A Manufacturers’ Guide to Ingredients, Products and Services
For A decade, the Nutrition Industry Executive Science of Supplements section has been crafted to help manufacturers gain a better understanding of the ingredients and services available that can make their products stand out in a crowded market. It gives the magazine’s advertisers an opportunity to describe in some detail the research that substantiates their branded ingredients, products and company services.
These companies have responded to this opportunity with background information about the health concerns their products are intended to address, histories of nutrients behind their ingredients and details of research that has been carried out.
We’ve also provided company addresses, phone numbers,email and website addresses to make obtaining additional information as easy as possible.Following is an index of companies participating in the Nutrition Industry Executive Science of Supplements: Spring Issue section:
Albion Human Nutrition
100 Maple Park Blvd., Ste. 110
St. Clair Shores, MI 48081
Phone: (800) 222-0733
Fax: (586) 774-8838
Email: firstname.lastname@example.org • Website: www.albionminerals.com
Chelated Mineral? The Proof is in the Bonds
By Stephen D. Ashmead
Chelated minerals have become a popular mineral supplement choice with claims of increased bioavailability, lower toxicity and, in some cases, improved palatability. All of these desired functions are attributed to the chelation effect. Since so many attributes are dependent on the effect, discriminating buyers want proof of chelation.
Methods for proving chelation vary in sophistication and availability. They can range from very expensive and specific methods that would require a laboratory equipped like a university is, to simple methods that any skilled technician can perform on a laboratory bench.
In recent years, these simple methods have received increased attention and various methods have been proffered as standard methods for proof of chelation. Examples of these methods utilize solubility1, molecular sieving, ion specific electrodes2 and elemental analysis. While all analytical methods have their limitations, each of these simple methods begin with the basic assumption that the product is chelated before the assay is performed. Because of this flawed assumption, it allows for unscrupulous manufacturers to put together products that claim to be a chelate according to the described test and yet, have nothing more than an admixture with no actual chelates present in the product. A simple example is ion specific electrode technology, which cannot tell the difference between an insoluble inorganic salt and a truly chelated mineral.
Even recently published research3 has aggravated the situation by perpetuating the use of flawed methods. Because of this, it is imperative that whatever method is chosen or developed can provide direct evidence of chelation bonds from the chelating ligand to the metal.
Albion’s research team has developed a method for the analysis of metal amino acid chelates via Fourier-transforming infrared spectroscopy (FT-IR). This method is ideal for this application because it analyzes for the vibrational energies of the chemical bonds that are present in the molecule and form the chelate bonds. The model for this method was zinc bisglycinate chelate that was analyzed and structurally confirmed as chelated through X-ray crystallography. Albion’s team was able to identify the changes in the FT-IR spectrum that were associated with the formation of the chelation bonds. In addition, the company was able to confirm and identify through FT-IR means the formation of the heterocyclic ring structure that is a requirement of metal chelation. It’s team was also able to successfully extend the model to other metal amino acid chelates.
Once the team had identified the infrared spectral differences between the free ligand and the chelated product, it turned its attention to the development of a quantification method for the amount of metal that is chelated in a sample. It was successful in developing a model and method for glycine. This method will allow the company to detect as low as one percent free glycine with a typical relative standard deviation of about five percent. The team has confirmed that the kind of metal that is chelated does not have an effect on this assay. From a theoretical point, this method will work for all amino acids. The team is in the process of developing standards to confirm this.
For the first time, there is an analytical method coupled with standard chemical analysis that is an effective compromise between the complexity, cost and definitive answer of a test, such as X-ray crystallography, and the low cost, simplicity, but very vague results of solubility, molecular sieving, ion-specific electrode analysis and other misapplied or compromised tests. FT-IR analysis can produce positive proof of the existence of chelation bonds and can provide a means for the quantification of the amount of metal chelated to amino acids. This will allow buyers and their QA/AC staff and researchers to determine the veracity of the manufacturer’s claims.
1 Brown TF and Zeringue LK, J.Dairy Sci
2 Leach PA and Patton RS, Feedstuffs,
March 31, 1997, p. 13.
3 Cao J, et al., J Anim Sci 2000;78:2039.
Stephen D. Ashmead is vice president of research and development at Albion Advanced Nutrition, a leading manufacturer of metal amino acid chelates. He can be contacted at email@example.com.
P.O. Box 357
Big Bend, WI 53103
Phone: (262) 662-5533
Fax: (262) 662-2828
In Any Form, GLA is Essential for Good Health
Research for gamma linolenic acid (GLA) has shown benefits in cardiovascular health, joint health, women’s health, weight management and skin health. Any time a natural ingredient can target several areas, cost-savvy supplement manufacturers and multitasking customers both benefit.
It helps, of course, if GLA is readily available. With borage oil in short supply after a couple of surplus stock years, CONNOils now offers GLA from borage oil and GLA safflower oil in the form of Arcadia Biosciences’ SONOVA™ 400 GLA Safflower Oil, which has received new dietary ingredient certification from the Food and Drug Administration.
Chemically identical to what is found in other GLA sources, such as evening primrose and borage, GLA safflower oil is the most concentrated and economical source of GLA available. SONOVA 400’s quality is guaranteed via its processing, which is performed at the lowest possible temperatures using proprietary techniques and conditions designed to minimize oxidation.
The vehicle for GLA may have changed, but the lack of GLA in our bodies has not. Bad lifestyle habits and health conditions (such as diabetes) contribute to insufficient quantities.
GLA’s glowing research illuminates the value of this versatile omega-6 fatty acid:
• In 2002, researchers from Broussais Hospital in Paris found that exogenous supplementation of GLA over three months (on 10 mobile, elderly subjects) was associated with a beneficial reduction of cardiovascular risk factors, such as HDL cholesterol.1
• In 2002, researchers at the University of Massachusetts Medical School, department of medicine, discovered that GLA reduced joint inflammation in patients with rheumatoid arthritis.2 In 1996, a study from the University of Massachusetts Medical Center determined that “treatment with GLA for six months resulted in statistically significant and clinically relevant reductions in the signs and symptoms of disease activity in patients with RA [rheumatoid arthritis].”3
• In a 2011 Brazillian study, capsules of polyunsatured acids (including 210 mg GLA) were given to 120 women suffering from PMS divided into three groups. Symptoms were recorded over a six-month period using the Prospective Record of the Impact and Severity of Menstruation (PRISM) calendar. In the 1 g treatment group, a significant reduction was found when the median PRISM score recorded in the luteal phase at baseline (99) was compared with the median score recorded in the third month (58). In the 2 g group, these differences were even more significant (baseline score: 98; third month: 48; sixth month: 28).4
• In a yearlong study, researchers at the University of California, Davis’ department of nutrition concluded that GLA reduced weight regain in formerly obese humans following major weight loss.5
• A randomized, double-blind, placebo- controlled Swiss study of healthy adults tested the effects of GLA (in evening primrose oil) on the skin. Supplements were administered orally in soft gel capsules, 3 x 500 mg b.i.d. for 12 weeks. After 12 weeks, transepidermal water loss, elasticity, firmness, fatigue resistance and roughness had improved by 12.9, 7.7, 4.7, 16.7, 14.2 and 21.7 percent, respectively, in the evening primrose group compared with placebo.6
Along with providing quality natural products and contract manufacturing solutions, CONNOils is committed to providing first-rate customer service. The company welcomes any questions regarding GLA and its myriad formulation possibilities. For more information, call (262) 662-5533 or visit www.connoils.com.
1 The effect of gamma-linolenic acid on plasma and membrane lipids and renal prostaglandin synthesis in older subjects. Hornych A., Oravec S., Giault F. Broussais Hospital, Paris, France. Bratisl Lek Listy, 2002: 103(3); 101-7.
2 Oral administration of gamma-linolenic acid, an unsaturated fatty acid with anti-inflammatory properties, modulates interleukin-1beta production by human monocytes. Furse RK, Rossetti RG, Seiler CM, Zurier RB. University of Massachusetts Medical School, Department of Medicine, Worcester 01655, USA. J Clin Immunol. 2002 Mar;22(2):83-91.
3 Gamma-Linolenic acid treatment of rheumatoid arthritis: A randomized, placebocontrolled trial. Zurier RB, Rosetti RG, Jacobson EW, et al. University of Massachusetts Medical Center, Worcester, USA. Arthritis Rheum, 1996 Nov;39(11): 1808-17.
4 Essential fatty acids for premenstrual syndrome and their effect on prolactin and total cholesterol levels: a randomized, double blind, placebo- controlled study. Rocha Filho, EA, Lima JC, Pinho Neto, JS. Department of Maternal and Child Healthcare, School of Medicine, Federal University of Pernambuco, Recife, Pernambuco, Brazil. Reproductive Health 2011, 8:2 doi:10.1186/1742-4755-8-2.
5 Gamma-linolenate reduces weight regain in formerly obese humans. Shirmer, MA, Phinney, SD. Department of Nutrition, University of California, Davis, CA, USA. Journal of Nutrition, 2007, June; 137(6): 1430-5.
6 Systemic evening primrose oil improves the biophysical skin parameters of healthy adults. Muggli, R. AdviServ Consulting, Rotbergstrasse 11, CH-4114 Hofstetten, Switzerland. International Journal of Cosmetic Science, 2005, 27, 243–249.
Cyvex Nutrition, Inc.
(A Subsidiary of Omega Protein Corporation)
1851 Kaiser Ave.
Irvine, CA 92614
Phone: (949) 622-9030
Fax: (949) 622-9033
Email: firstname.lastname@example.org • Website: www.cyvex.com
DPA: An Increasingly Crucial Link for Heart Health and Cognitive Function
Building the Case for DPA
For more than 30 years, extensive scientific and clinical research has been conducted on the potential therapeutic and nutritional value of long-chain omega-3 fatty acids in human health and nutrition. Long-chain omega-3 fatty acids are required for human health, but are not produced by the body. The collective research on omega-3 fish oils has demonstrated therapeutic benefits in regards to neural function, inflammation, cardiovascular disease, and cholesterol and lipid profiles.
In recent years, research has been tailored to reflect specific individual fatty acids, of which the most popular include EPA and DHA. These two fatty acids are commonly found in numerous fish species. However, there is another fatty acid, an intermediary between EPA and DHA called docosapentaenoic acid (DPA), which has recently been called the “missing link” to the larger health puzzle.
DPA has increasingly caught the attention of the medical and scientific communities, as developing research is showing its distinct and powerful role as a nutritional and therapeutic supplement in such diverse conditions as cardiovascular disease, cognitive decline, and cholesterol and triglyceride health.
DPA: A Current Scientific Overview
While a variety of fish oils are good sources of omega-3 fatty acids, the majority of these lack a meaningful amount of DPA. Emerging evidence now seems to indicate DPA plays a substantial role in nutritional supplementation, as it has therapeutic potential to work synergistically with EPA and DHA, and as a stand-alone fatty acid. Below is a summary of the most significant, current scientific findings:
• Protective Role in Cardiovascular Health:
While much work has previously shown that omega-3 fatty acids can play a protective role in preventing cardiovascular disease, two clinical studies have demonstrated a positive correlation between DPA and the prevention of cardiovascular disease in humans.
First, researchers in Eastern Finland published a study demonstrating DPA’s role in reducing the risk of acute coronary events. Second, a Japanese study published five years later further corroborated these findings and additionally found a significant association between DPA supplementation and reduced cardiovascular disease.
In addition, DPA has been reported to have a positive role in reducing the expression of inflammatory genes, thereby improving cardiovascular health.
• Reducing Triglycerides and Cholesterol:
Over the years, numerous studies have demonstrated that EPA and DHA can lower triglycerides (TG) and cholesterol levels in the plasma and liver. Recently, similar research has shown that DPA also possess lipid metabolism improving effects similar to EPA and DHA. Results point to a synergistic potential of the three compounds in nutritional supplementation for improving cholesterol and TG levels.
• Protective Role in Cognition:
Within the last year, researchers at Trinity College in Dublin, Ireland, published a groundbreaking study that demonstrated DPA plays a significant role in protecting against normal cognitive decline due to aging and general loss of synaptic function. By supplementing the normal diets of rats with DPA, it was found that DPA possesses neuro-restorative effects in the hippocampus of these rats by decreasing two major biochemical mechanisms: microglial activation and oxidative stress.
Menhaden: A Significant Source of DPA
Fish oil sourced from the menhaden species—marketed as OmegaPure® for functional foods and OmegaActiv™ for dietary supplements—is regarded as the No. 1 source of DPA, based on USDA (US Department of Agriculture) National Nutrient Database Release 22 (SR22). DPA is important to overall bodily function, as nearly one-third of the long-chain omega-3 fatty acids circulating in human blood are attributable to DPA.
Omega-3 fatty acids have consistently been shown to play a positive role in preventative and protective health and are now thought to be an important part of any healthy lifestyle. While more scientific and clinical work remains to be done to fully understand and comprehend the role of DPA as a nutritional supplement, it is becoming clear that fish oil supplementation containing DPA —in addition to EPA and DHA—most likely represents a more powerful synergistic nutritional supplement compared with oil extracts containing EPA and DHA alone.
Choi J., et. al. J Med Food. 2009 Apr;12(2):320-6.
Matsumoto K. J Agric Food Chem. 2002 Dec 4;50(25):7244-8.
Miyazaki K, et. al. J Agric Food Chem. 2008 Dec 10;56(23):11485-92.
Shan Q, et.al. J Biomed Biotechnol.2009:564737.
Shindo M, et. al. J Nutr Sci Vitaminol (Tokyo). 2007 Feb;53(1):90-3.
Steed L, et al. J Food Sci. 2008 Jun;73(5):S215-21.
Suda I, et. al. Eur J Clin Nutr. 2008 Jan;62(1):60-7.
Wang YJ, et. al. Neurochem Int. 2010 Feb;56(3):424-30.
Draco Natural Products
539 Parrott St.
San Jose, CA 95112
Phone: (408) 287-7871
Fax: (408) 287-8838
Email: email@example.com • Website: www.dracoherbs.com
Health Benefits of a New Super-Food: Purple Sweet Potato
Purple sweet potato (PSP) is a purple variety of sweet potato with the predominant pigments as red and purple anthocyanins, which are also found in berries and grapes. Originally from South and Central America and the West Indies, the purple version has spread all over the world, including China and Japan, where it is quite popular. The sweet potato is known botanically as Ipomoea batatas, a species in the morning glory family (Convolvulaceae), and is only remotely related to the potato (Solanum tuberosum). It occurs naturally with many colors based on the variation of carotenes and anthocyanin plant pigment groups, and is a potent source of many other nutrients.
PSP is used in other countries to provide a unique flavor, natural color, antioxidants and nutrients to native cuisine, beverages and processed foods. In the Philippines, a medium bright lavender color from purple sweet potatoes is known as “ube,” which gives a beautiful color to foods, including pastries, ice cream and puddings, and contributes to a pleasant flavor. A concentrated PSP juice is used for similar purpose and also increasingly as a health food.
Many health benefits have been discovered for purple sweet potato. Blood pressure lowering effects were observed in hypertensive animals fed with one percent anthocyanins from PSP. In another study, atherosclerotic lesions, glycation of protein and oxidation of LDL cholesterol was reduced by the extract. It has valuable physiological effects in the brain similar to those of blueberries and includes reduction in cognitive deficits, oxidative damage and inflammation in aging mouse brain induced by toxins. Other studies found reduced death of brain cells caused by beta-amyloid oxidative stress (a key marker in Alzheimer’s disease), reduced inflammation of the aging brain, and improvements in spatial learning and memory deficits by expression of synaptic proteins.
The other phenolic-rich compounds found in PSP include caffeic acid (also found in artichokes, apples and herbs) and ferulic acid also found in brown rice. These amounts are about 1,000 to 2,000 mg total per 100 g of the juice, and are thought to be very beneficial type antioxidants that reduce inflammation, have preventative effects in diabetes and reduce cancer risk. The rich level of several phytocompounds in PSP extract has been shown to significantly increase plasma antioxidant capacity within ranges reported for various purple- colored fruits and vegetables.
A randomized, doubleblind, placebo-controlled, parallel human study of liver health found that a purple sweet potato drink providing 200 mg of anthocyanins significantly decreased serum levels of hepatic GGT enzymes. The improvement of liver enzymes indicated an improvement of liver function in men with borderline hepatitis.
Since deep red anthocyanins are found in higher concentrations in PSP, their relationship to various human health benefits from studies of anthocyanins from other food sources should be considered. A wide range of benefits were found with the following dosages of anthocyanins: 200 mg improved myopia (near-sightedness) and night vision; 320 mg lowered LDL cholesterol by 13 percent; 34 mg reduced oxidative stress in rowers; just 19 mg reduced LDL oxidation in human subjects; 240 mg lowered oxidative stress in humans following exercise (important for physical recovery); 300 mg lowered systemic inflammation in adults; and 50 mg of anthocyanin improved adaptation to darkness, video display terminal eye fatigue and subjective asthenopia symptoms (visual fatigue).
The wealth of other nutrients in PSP includes potassium, magnesium, manganese, copper, iron, calcium, vitamin C and B vitamins. PSP juice concentrate contains very generous levels of the electrolyte potassium with 100 g per day providing 1,300 mg of potassium and 142 mg of magnesum. Other levels of minerals include a modest amount of calcium (62 mg), which supports strong bones, teeth and muscle function, and also helps control blood pressure. Zinc and iron are also present in modest amounts with about 2 mg and 2.5 mg, respectively, in 100 g of PSP juice concentrate.
Choi J., et. al. J Med Food. 2009
Matsumoto K. J Agric Food Chem. 2002
Miyazaki K, et. al. J Agric Food Chem. 2008
Shan Q, et.al. J Biomed
Shindo M, et. al. J Nutr Sci Vitaminol (Tokyo).
Steed L, et al. J Food Sci. 2008
Suda I, et. al. Eur J Clin Nutr. 2008
Wang YJ, et. al. Neurochem Int. 2010
Ecuadorian Rainforest, LLC
25 Main St., Bldg. #6
Belleville, NJ 07109
Phone: (973) 759-2002
Fax: (973) 759-3002
Email: firstname.lastname@example.org • Website: www.intotherainforest.com
Managing Weight Like Brazilians
Nutrition industry manufacturers are facing tighter budgets and fierce competition. Finding costeffective ingredients as well as ones that can help continue to innovate is imperative. Often this means looking beyond North America for supplies.
Yet at the same time, importing ingredients can be fraught with problems.
With the long overdue FDA enforcement of good manufacturing practices (GMPs) and heightened consumer wariness about imported foodstuffs, manufacturers can’t afford to sacrifice rigorous quality oversight for savings or new finds.
However, it doesn’t need to be a trade-off.
South American countries can provide ingredients that are not only cost-effective and high-quality, but also bring novelty and innovation to the arena. But for manufacturers to make the most of South America’s potential as a source for high-value ingredients, they need to find an ingredient supply partner who meets certain criteria.
Prevalence of Obesity in the United States 2009-2010
The prevalence of obesity in the United States has remained an alarmingly high percentage over the past years.
According to the Center for Disease Control:
• More than one-third of U.S. adults (35. 7 percent) are obese.
• No state has met the nation’s Healthy People 2010 goal to lower obesity prevalence to 15 percent. The number of states with an obesity prevalence of 30 percent or more has increased to 12 states in 2010. In 2009, nine states had obesity rates of 30 percent or more. In 2000, no state had an obesity prevalence of 30 percent or more.
• Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of death.
• In 2008, medical costs associated with obesity were estimated at $147 billion; the medical costs paid by thirdparty payers for people who are obese were $1,429 higher than those of normal weight.
Chá de bugre: Bikini-Loving Brazil’s Hoodia
Hit any beachside refreshment stand in Rio and you’re likely to find some version of Chá de bugre. Chá de bugre tea, extracts and tinctures are sold throughout Brazil as weight-loss aids and cellulite erasers.
Chá de bugre contains some caffeine, along with potassium, allantoin and allantoic acid. However, the caffeine levels do not seem to be the sole reason behind its role as a weight-loss aid. Chá de bugre has some diuretic effects.* And most notable, users report it suppresses appetite without creating a dramatic craving for food when it wears off. The allantoin and allantoic acid may be a factor in the ingredients effect on cellulite.
While Brazil’s bikini-clad bodies may testify to Chá de bugre’s effectiveness, it still has not been researched extensively as a weight-loss aid. Animal studies on its toxicity show it is very safe to ingest.* And other preliminary research reveals it may affect viruses and help in regulating healthy cell growth. Traditionally, Chá de bugre is also used as a heart tonic, for renal health, to relieve coughs and heal wounds.
Chá de bugre’s bright red berries give it the name of the café do mato (coffee of the woods). A small tree of 8-12 meters, Chá de bugre grows in Brazil, Argentina and Paraguay.
Potential Beyond a Weight- Management Ingredient
Other scientific studies have been conducted by various organizations on the benefits of chá de bugre (cordia salicifiolia):
• According to the Toyama Medical and Pharmaceutical University Toyama, Japan, an extract of cordia salicifolia showed an inhibitory effect on herpes simplex virus type 1.
• The extract of cordia salicifolia, along with other ingredients, was used to create a virudicdal formula by The Stephan Angeloff Insititute of Microbiology, Bulgarian Academy Of Sciences Sofia, Bulgaria. The formula was studied for its surface disinfecting properties, sterilization of blood and as a product for antiviral chemotherapy.
Caparroz-Assef SM et al. Toxicity studies of Cordia salicifolia extract. Acta Sci. Health Sci. 2005 27(1), p. 41-44.
Taylor, L. The Healing Power of Rainforest Herbs. Garden City Park, NY: Square One Publishing, 2005.
Navickiene S et al. Two-dimensional coordination polymer matrix for solid-phase extraction of pesticide residues from plant Cordia salicifolia. SE, Brazil J Sep Sci. 2009 Jun;32(12):2132-8.
Tirillini B. Phytochemical investigation on leaf extract of Cordia salicifolia Cham J Med Food. 2008 Mar;11(1):193-4.
* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
2213 Missouri Ave.
Carthage, MO 64836
Phone: (866) 804-8034
20 Research Park Dr.
St. Charles, MO 63304
Phone: (888) 403-5039
Natural Eggshell Membrane for Joint Health
Ease of body movement is one of the main components needed to support optimal health, and this movement depends upon the proper functioning of our joints. Our joints enable the basic movements necessary to facilitate normal daily activities and provide the flexibility for maintaining an active lifestyle. Unfortunately, our joints take a lot of abuse. We exercise erratically, carry too much weight and experience the normal joint deterioration that results from aging.
There are numerous dietary supplement products designed to address joint tissue health. Most of these products contain one or more ingredients that are recognized as playing some role in joint tissue structure. Ingredients such as glucosamine, chondroitin or MSM are familiar to those who are interested in natural ways of protecting and maintaining healthy joint tissue, and products containing one or more of these ingredients are popular with the end consumer.
However, another ingredient is beginning to gather attention for its noteworthy benefits to joint health. Natural eggshell membrane, or NEM®, is an ingredient derived from the inner membrane of chicken eggshells. NEM is a natural source for many substances known to comprise healthy joint tissue including glycosaminoglycans, such as chondroitin sulfate and hyaluronic acid, as well as collagen and tissue-supporting proteins and amino acids. This unique combination of joint-supporting substances may explain NEMs striking benefits.
NEM has been extensively studied, both for its safety and for its positive effects on joint functioning. Multiple studies have demonstrated that not only does NEM work as well or better than other ingredients in this category, but it also offers some noticeable advantages.
The results from two open-label studies demonstrated the positive effects of NEM in decreasing joint pain and stiffness. Both studies evaluated levels of pain and one study also evaluated improvements in range of motion. The dosage for both was a single daily 500 mg dose of Membrell’s (ESM Technologies) JOINThealth, a retail product containing NEM. It should be noted that the small single daily dose of 500 mg is considerably less than the recommended dosage for other joint support products, such as glucosamine or chondroitin.
In a separate randomized, multi-center, double-blind, placebo-controlled clinical study, 500 mg daily of Membrell’s NEM was found to statistically reduce both pain and stiffness in patients with knee osteoarthritis in as little as 10 days. None of the participants experienced the gastric or cardiovascular side effects often associated with NSAIDS, a result that is significant for those who take joint health products on a regular basis.
Two more recent studies have investigated NEMs safety and its effects in suppressing inflammatory cytokines. The first study examined the effects of NEM on the production of immune system mediators including tumor necrosis factor- á. The results were positive and, in particular, the suppression of TNF-á production in the presence of NEM subjected to in vitro digestion provided an additional indicator that NEM might offer benefits as a consumable antiinflammatory product.
The results of the second study reinforced the safety profile of NEM. In this study NEM was evaluated via in vitro and in vivo (animal) toxicological studies. Cytotoxicity, genotoxicity and oral toxicity (single acute dose and 90-day repeated-dose) at doses up to 50 times the clinically tested human equivalent dose were evaluated. Except for individuals with an allergy to egg, NEM is safe, even for extended long-term use.
NEM can be used by ovo-vegetarians, is derived from a domestic renewable source and is free from contaminants. From individuals who engage in regular sports or athletic endeavors to those who simply want to remain active into middle age and beyond, a supplement containing NEM can be an important addition to any supplement regimen.
Benson KF, Ruff KJ, Jensen GS. “Effects of natural eggshell membrane (NEM) on cytokine production in cultures of peripheral blood mononuclear cells: Increased suppression of tumor necrosis factor-· levels after in vitro digestion”. J Med Food. December, 2011, ahead of print.
Ruff KJ, Endres JR, Clewell AE, Szabo JR, Schauss AG. “Safety evaluation of a natural eggshell membrane-derived product”. Food Chem Toxicol 50(3-4):604-611 (2012).
Ruff KJ, DeVore DP, Leu MD, Robinson MA. “Eggshell membrane: a possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies”. Clin Interv Aging 4: 235-40 (2009).
Ruff KJ, Winkler A, Jackson RW, DeVOre DP, Ritz BW. “Eggshell membrane in the treatment of pain and stiffness from osteoarthritis of the knee: a randomized, multicenter, double-blind, placebo-controlled clinical study”. Clin Rheumatol 28(8): 907-14 (2009).
1550 Utica Ave. S., Ste. 770
Phone: (952) 400-0403
Fax: (952) 937-7667
Email: email@example.com • Website: www.humaneticsingredients.com
The Science of 7-Keto: All Natural, Clinically Proven Weight Loss
7-Keto® (a trade name for the compound 3-acetyl-7-oxo dehydroepiandrosterone, or 7-oxo DHEA) is a substance found naturally in the human body. Its presence in human urine was first documented in 1958.1,2 It is a natural metabolite of the hormone DHEA, and like DHEA, it is known to decline with age.2
7-Keto is structurally different from DHEA and has unique characteristics that render its functionally distinct from DHEA. Unlike DHEA, 7-Keto does not convert to testosterone or estrogens in the body,3,4 7-Keto is not a steroid hormone precursor, nor does it have androgenic or anabolic potential.5
Using 7-Keto as a dietary supplement is, functionally, reclaiming what has been lost through the aging process. The documented science behind 7-Keto provides strong support that it is safe and effective for helping consumers lose weight and maximize results from diet and exercise.
7-Keto is marketed as a non-stimulant thermogenic agent to increase metabolism for weight loss. It is protected by several patents including (U.S. 7,199,116) for the use of 7-Keto for Modulating the Basal Metabolic Rate.
7-Keto’s efficacy is supported by two randomized, double-blinded, placebocontrolled (RDBPC) weight loss clinical trials. The first study indicated that 7-Keto increased weight loss over an eight-week period by 200 percent more than placebo.6 A second trial confirmed these results. The second trial, also RDBPC, confirmed that weight-loss over an eight-week period could be increased by a factor of three times.7 Importantly, each of these studies confirmed that majority of the weight lost was body fat. Each study controlled for diet, exercise and diuresis effects, and both have been published in international peer reviewed journals.
Results of an additional human clinical study reveal that administration of 7- Keto to overweight adults in conjunction with a calorie-restricted diet will effectively reverse the decline in resting metabolic rate normally associated with dieting. In this study, a cross-over design in which each participant served as his or her own control, 7-Keto plus a restricted-calorie diet demonstrated an increase in resting metabolic rate by 1.4 percent above baseline levels versus a 3.9 percent decrease in resting metabolic rate in the restricted calorie diet only group. Therefore, the addition of a 7-Keto to a restricted-calorie diet produced a statistically significant 5.4 percent increase in daily resting metabolic rate when compared to a calorie-restricted diet alone.8
Since introduction as a dietary ingredient in 1998, 7-Keto has been the subject of study in 10 well-controlled human clinical studies, including a Phase I safety assessment conducted at the Chicago Center for Clinical Research.4 Each of these studies monitored laboratory values and adverse events. In all studies, in addition to over 800 million daily doses in sales, no serious adverse events were attributed to the ingestion of 7-Keto.
1 Gallagher TF. Adrenocorticol Carcinoma in Man. The Effect of Amphenone on Individual Ketosteroids. Clin Endocrinol Metab. 1958;18:937-949.
2 Marenich LP. Secretion of Testosterone, Epitestosterone, Androstenedione, and 7- Keto(r)-Dehydroepiandrosterone in Healthy Men of Different Ages. Prob Endokrinol. 1979;25(4):28-31.
3 Lardy H, Kneer N, Wei Y, Partridge B, Marwah P. Ergosteroids II: Biologically Active Metabolites and Synthetic Derivatives of Dehydroepiandrosterone. Steroids. 1998;63:158-165.
4 Davidson M, Marwah A, Sawchuk RJ, Maki K, Marwah P, Weeks C, Lardy H. Safety and Pharmacokinetic Study with Escalating Doses of 3-acetyl-7-oxo-dehydroepiandrosterone in Healthy Male Volunteers. Clin Invest Med. 2000;23:300-310.
5 Miyamota H, Yeh S, Lardy H, Messing E, Chang C. Delta-5-Androstenediol is a Natural Hormone With Androgenic Activity in Human Prostate Cancer Cells. Proc Natl Acad Sci. 1998;95:11083-11088.
6 Kalman DS, Colker CM, Swain MA, Torina GC, Shi Q. A Randomized, Double-Blind, Placebo Controlled Study of 3-Acetyl-7-Oxo- Dehydroepiandrosterone in Healthy Overweight Adults. Current Therapeutic Research 2000;61:435-442.
7 Zenk JL, Helmer TR, Kassen LJ, Kuslowski MA. The Effect of 7-Keto Naturalean on Weight Loss: A Randomized, Double-Blind, Placebo- Controlled Trial. Current Therapeutic Research 2002;63:263-272.
8 Zenk JL, Frestedt JL, Kuskowski MA. HUM5007, A Novel Combination of Thermogenic Compounds, and 3-Acetyl-7-Oxo- Dehydroepiandrosterone: Each Increases the Resting Metabolic Rate of Overweight Adults. J Nutrit Biochem 2007;18:629-634.
Icon Group LLC
167 Main St., #208
Brattleboro, VT 05301
Phone: (802) 257-5345
WellTrim Ultima: The Ultimate African Mango Weight-Loss Nutraceutical
As the number of overweight people continues to rise, consumers are seeking innovative approaches to weight management, including consumption of patented, clinically proven dietary supplement ingredients with multiple mechanisms of action. African mango (Irvingia gabonensis) has a long history of use for both culinary and medicinal purposes, including weight management and metabolic wellness.
Now, Icon Group introduces the proprietary, branded ingredient WellTrim® Ultima, which features two clinically proven nutraceuticals, IGOB131® and SensorilTrim®. IGOB131 is the only clinically proven African mango extract patented for weight loss. SensorilTrim is a multi-patented, standardized extract of the revered ayurvedic botanical, ashwagandha (Withania somnifera), which enhances the benefits of IGOB131 through stress and cortisol reduction.
WellTrim Ultima Mechanisms of Action
The ingredients in WellTrim Ultima possess well-defined mechanisms of action that help improve functioning of the body’s adipocyte command signal network and reduce cortisol levels. This network consists of important fatderived hormones (leptin and adiponectin) and glycerol-3-phosphate dehydrogenase (G3PDH) enzyme.1
Leptin enhances satiety, metabolism, thermogenesis and blood sugar balance by crossing the blood-brain barrier and binding to receptors in the brain. Research has found that in overweight people with increased levels of inflammation, leptin function decreases when leptin becomes bound by C-reactive protein (CRP) and is prevented from crossing the bloodbrain barrier.2 This leptin resistance often causes weight gain.
Adiponectin potentiates leptin function and also acts independently to modulate blood sugar levels. Weight loss can be impeded in overweight people who normally have lower adiponectin levels. Because G3PDH converts blood sugar into stored fat, high G3PDH activity can contribute to weight gain. Research has shown that improving leptin function by reducing CRP and leptin levels, increasing adiponectin and lowering G3PDH activity are effective weight-loss mechanisms.3,4
Persistent stress and increased levels of cortisol, which are prevalent in people on calorie-restricted diets, may inhibit overall weight management results.5 This, in part, is due to the fact that cortisol, a stress hormone, can disrupt the adipocyte command signal network. The incorporation of SensorilTrim with African mango IGOB131 in WellTrim Ultima helps reduce overall stress levels and corresponding cortisol levels, which is an important strategy in optimizing leptin and adiponectin function for superior weight management.
WellTrim Ultima Contains Clinical Proven Ingredients
Multiple randomized, double-blind, placebo-controlled, human clinical trials have demonstrated the weight management benefits of the ingredients in WellTrim Ultima.6,7 In a 10-week trial, 102 healthy subjects (BMI 26 and greater) received the amount of IGOB131 African mango extract found in a dose of WellTrim Ultima, or placebo, twice daily. The IGOB131 group lost 28 pounds, 6.7 inches in waist circumference and 6.3 percent in body fat; CRP levels dropped by 52 percent and leptin was reduced 49 percent while adiponectin rose 159 percent in study participants. In a separate ex vivo study, researchers found that IGOB131 inhibited G3PDH activity by 71.6 percent compared to a control.8
In a 60-day trial involving 98 subjects, consumption of the amount of SensorilTrim found in a dose of WellTrim Ultima resulted in significant reductions in stress (69.9 percent) and cortisol levels (24. 2 percent) as well as enhanced mood.7 CRP levels also dropped by 36. 6 percent. By increasing resistance to stress and reducing cortisol and CRP levels, SensorilTrim acts synergistically with IGOB131 to help support healthy functioning of the body’s adipocyte command signal network. Because stress is a major cause of carb cravings and snacking for many consumers who are trying to lose weight, the stressreducing properties of SensorilTrim also help WellTrim Ultima promote increased resistance to stress-induced overeating.
In both clinical trials, subjects also experienced significant improvements in blood sugar balance and cholesterol levels. Subjects experienced no adverse effects in either trial. The results of the combined studies demonstrate the ability of WellTrim Ultima ingredients IGOB131 and SensorilTrim to help improve leptin and adiponectin function by reducing CRP, leptin and cortisol levels, as well as increasing adiponectin levels. These combined results substantiate structure/function claims in the areas of weight management, satiety, appetite control, thermogenesis, stress reduction and overall metabolic wellness.
1 Meier U and Gressner AM, Clin Chem 50(9):1511-1525.
2 Chen K, et al. 2006. Nat Med 12:425-432.
3 Okauchi Y, et al. 2009. Diabetes Care 32(10):e122.
4 Verdich C. 2001. Obes Res 9(8):452-461.
5 Block JP, et al. 2009. Am J Epidem 170(2):181-192.
6 Ngondi JL, et al. 2009. Lipids Health Dis 8:7-13.
7 Auddy B., et al. 2008. JANA 11:50-56.
8 Oben JE, et al. 2008. Lipids Health Dis 7:44-49.
5451 Industrial Way
Benicia, CA 94510
Phone: (800) 783-4636
Websites: www.interhealthusa.com • www.facebook.com/InterHealthNI • www.twitter.com/InterHealthNI
Meratrim: Two-Week Weight Management Results
Meratrim™ was shown in two randomized, double-blind, placebo-controlled clinical studies to be safe and effective for reduction in body weight as well as hip and waist circumference. With these statistically significant results, Meratrim can help consumers achieve significant weight management benefits in just two weeks.
Meratrim is a proprietary blend of two plant extracts, Sphaeranthus indicus flower heads and Garcinica mangostana fruit rind. Each plant contributes an essential part to Meratrim’s ability to affect multiple pathways involved in fat cell formation and breakdown. Pooled data from these two randomized, doubleblind, placebo-controlled studies compared The weight-loss effects of 800 mg of Meratrim (400 mg twice a day) or a placebo on 100 people for eight weeks.
Clinical research results demonstrate that the weight management effects of Meratrim occur as early as two weeks after starting supplementation. After two weeks, Meratrim reduced body weight by 4.5 pounds and both waist and hip by more than an inch.
James Lugo, PhD, InterHealth’s director of research and development and one of the Meratrim researchers, said he believes that the two-week data findings are especially important. “These are important findings because they indicate that individuals who are on a 2,000 calorie standard diet and use Meratrim may, in many cases, experience a relatively quick response, both with respect to weight loss and body remodeling, thereby receiving the early encouragement needed to remain on their weight-loss plan.”
By the end of the research, Meratrim significantly reduced body weight by 11. 5 pounds and waist and hip circumference by 4.7 and 2.5 inches, respectively. In contrast, placebo reduced body weight by 3.3 pounds and waist and hip circumference by 2.4 and 1.2 inches, respectively, after eight weeks.
Two Clinical Trials
Both clinical studies were randomized, double-blind, placebo-controlled and included parameters that reflect real-life weight-loss scenarios. Study participants walked 30 minutes five days a week and followed a standard calorie diet (2,000 kcal/day) as opposed to being placed on a low-calorie diet which is a common practice in weight control studies. With this approach, the studies addressed and avoided the well-documented failure of individuals to maintain their diet restrictions.
“We believe that the results derived from this research are more readily applicable to personalized diet planning, and emphasize the need to combine a healthy lifestyle change that includes a healthy diet and moderate increases in physical activity together with Meratrim supplementation to achieve results,” said Dr. Lugo.
Two Areas of the Body
Body fat is stored in a number of places, including in the waist and hip.
Meratrim has been clinically shown to reduce inches off these particular areas, helping to slim the stomach and hips, in just two weeks. Meratrim’s ability to reduce body weight, hip and waist circumference may be due to its clinically studied ability to significantly increase the fat-burning hormone, adiponectin.
Additionally, preliminary data demonstrates Meratrim’s ability to Reduce the expression of several key biomarkers involved in the formation, growth and storage of fat. Based on these findings, it can be inferred that Meratrim increases fat metabolism and decreases fat accumulation.
Comprehensive Safety Profile
Both S. indicus and G. mangostana have a history of use spanning hundreds of years in traditional medicinal preparations from Southeast Asia. A comprehensive safety profile on Meratrim has been established demonstrating a wide margin of safety for human consumption based on human clinical trials and an array of toxicological studies.
Judith Stern, ScD, RD headed the research. Dr. Stern is a distinguished professor in the Departments of Nutrition and Internal Medicine/Division of Clinical Nutrition and Metabolism at the University of California, Davis. According to Dr. Stern, “Results are encouraging and there does not appear to be significant risks. However, more research, including studying Meratrim for a longer period of time, should be conducted.”
Lau FC, Golakoti T, Krishnaraju AV, Sengupta K, Peerson J, Stern J. Multi-clinical trial evaluation on the weight management potential of Meratrim™ – A novel herbal formulation of Sphaeranthus indicus and Garcinia mangostana. Poster presented at: 61st Annual Obesity and Associated Conditions Symposium; October 26- 30, 2011; Las Vegas.
Durainpandiyan V, Kannan P, Ignacimuthu S. Antimicrobial activity of Sphaeranthus indicus. L. Ethnobotanical Leaflets. 2009;13:422-430.
Jung HA, Su BN, Keller WJ, Mehta RG, Kinghorn AD. Antioxidant xanthones from the pericarp of Garcinia mangotana (mangosteen). J Agric Food Chem. 2006;54:2077-2082.
* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Jost Chemical Company
8150 Lackland Rd.
St. Louis, MO 63114
Phone: (314) 428-4300
Fax: (314) 428-4366
Email: firstname.lastname@example.org • Website: www.jostchemical.com
Jost Chemical Company Introduces Calcium Magnesium Citrate Co-Salt
By J.R. Hardimon, P.H. Merrell, Y. Logoviyer, D.M. Akers
Jost Chemical Co. Has developed a proprietary process to produce a unique calcium magnesium citrate co-salt. This co-salt contains calcium and magnesium in a 2:1 Ca:Mg molar ratio. Isolation and characterization by EDTA titration, FTIR, ICP/MS and XRD have indicated the co-salt has a chemical formula of Ca2Mg(C6H5O7)2. 5H2O possessing a molecular weight of 572. 7 g/mol. Homogeneity and segregation studies have demonstrated that the cosalt is a unique compound and not a simple dry blend of calcium citrate and magnesium citrate. The FDA has approved this new product as an NDI (new dietary ingredient) for Jost Chemical Co.
Jost offers two product codes: Code 2200, Purified Powder and Code 2206, Purified Granular.
Code 2200, Purified Powder will prove beneficial to customers that desire aqueous suspensions of Ca and Mg with excellent mouth feel and unmatched suspension stability. It has been reported that dry blends of calcium citrate and magnesium citrate micronized powders combined and slurried in water (20-30 percent w/w) display extensive thickening, solidification and/or hardening. The two citrate salts react in the aqueous phase and precipitate a unique compound whose suspension is extremely thixotropic. This resulting mixture does not remain fluid and completely solidifies over time, providing difficult if not impossible dosing from the finished goods container. The solidification process is generally slow; however, experimental data demonstrates rapid acceleration of this reaction when heat (sterilization) is applied to the system. Jost’s calcium magnesium citrate co-salt stays in suspension and therefore alleviates solidification, hardening and flowability issues, even over an extended period of time.
Code 2206, Purified Granular will be most beneficial to customers that desire a directly compressible magnesium source for tablet manufacturing. Magnesium salts are typically very difficult to tablet. It is with great enthusiasm that we report the compressibility of calcium magnesium citrate co-salt exceeds that of Jost Chemical’s industry leading calcium citrate. Also noteworthy is the superior compression of code 2206 compared to a dry blend of calcium citrate and magnesium citrate.
The table above shows how compressibility of the metal citrates increases in the following order: magnesium citrate < 2:1 calcium citrate/magnesium citrate dry blend < calcium citrate < calcium magnesium citrate co-salt.
Nutritionally, calcium magnesium citrate co-salt closely matches the RDI (recommended dietary intake) of calcium and magnesium in a single dose. The RDI for Ca is 1,000 mg/day while that of Mg is 400 mg/day. Because of their respective molecular weights, this ratio of calcium to magnesium is very close to the correct RDI ratio. For example, if one takes 7,143 mg of this product, 1,000 mg of Ca and 303 mg of Mg would be provided.
This new calcium magnesium citrate co-salt, like many other products manufactured by Jost, has low levels of vagrant metals including a lead limit of 0. 2 ppm maximum.
Contact Jost Chemical for more information regarding this new co-salt and other mineral salts the company manufactures.
2D Janine Pl.
New Brunswick, NJ 08901
Phone: (732) 296-1080
Fax: (732) 296-1075
Email: email@example.com • Website: www.natreoninc.com
Capros: A Super Fruit Extract to Improve Endothelial Function, Mitigate Cardiac Risk Factors
Cardiovascular disease (CVD) is a major cause of death globally— more people die annually from CVDs than from any other cause.1 Smoking, hypertension, high LDL cholesterol, low HDL cholesterol and diabetes mellitus (DM) are the five major risk factors for CVD.2 DM is associated with an increased risk of atherosclerosis, which may result in coronary artery disease (CAD).3 Physiological impairments that link DM with a marked increase in atherosclerotic vascular disease include platelet hyper-reactivity, a tendency for negative arterial remodeling, impaired fibrinolysis, increased inflammation and endothelial dysfunction. Endothelial dysfunction, present at disease onset, may be the cause of atherogenesis that is present throughout the course of DM and associated with late-stage adverse outcomes.4,5 The endothelial dysfunction results from reduced bioavailability of the vasodilator nitric oxide (NO) due to accelerated NO degradation by reactive oxygen species.5 Oxidative stress, through superoxide production, is the most common pathogenic factor leading to insulin resistance, ß-cell dysfunction, impaired glucose tolerance (IGT) and ultimately to type 2 DM (T2DM). Thus, therapies aimed at reducing oxidative stress would benefit patients with T2DM and those at risk for developing diabetes.6,7,8
Phyllanthus emblica (Indian gooseberry, amla) is widely used in India as a vital food in many forms, such as pickles, juice, dried fruit and desserts, and in ayurveda for the treatment of various diseases. In-vitro and animal studies have indicated that Phyllanthus emblica has potent free radical scavenging effect, thus helping in systemic augmentation of antioxidant enzymes in animals and people.9 Capros®, which is a very well defined and standardized extract of Phyllanthus emblica from Natreon, Inc., was chosen to study its potential to improve cardiovascular health.
Capros, (Patents: U.S. 6,124,268, U.S. 6,290,996, U.S. 6,235,721, U.S. 6,362,167, U.S. 6,649,150 and E.P. 1 465 589 B1), a natural super antioxidant derived from the edible fruits of Phyllanthus emblica (Indian gooseberry) and standardized to contain at least 60 percent of combined emblicanin-A, emblicanin-B, punigluconin and pedunculagin as active ingredients, and having a very high ORACFN value of 47,110 ìmole TE/g (Brunswick Laboratories), has improved endothelial function and reduced cardiac morbidity, as evidenced by three pilot clinical studies: a 12-week, double-blind, randomized, parallel and placebo as well as positive (Atorvastatin 10 mg OD) controlled clinical study at a dose of 250mg BID with type 2 diabetic subjects having compromised endothelial activity; and two randomized, 14-day, double-blind, placebo-controlled crossover studies in healthy human subjects, at a dose of 500 mg BID, to assess the changes in cardiovascular parameters and aortic wave reflections induced by cold pressor stress test and mental stress test.
Capros, at 250 mg BID dosing, has shown significant improvement in endothelial activity in type 2 diabetics, compared to placebo, as evidenced by a increase in reflective index (RI), NO and glutathione, and a decrease in malonyldialdehyde (MDA). Capros has also improved the lipid profile as shown by a decrease in total cholesterol, LDL, triglycerides, Hs C-reactive protein (Hs-CRP) and platelet aggregation, and an increase in HDL. The decrease in LDL and the increase in HDL with Capros were almost comparable to the results obtained with Atorvastatin (10 mg OD), and inhibition of platelet aggregation with Capros is Nearly three times that of Atorvastatin.
Reduction of Hs-CRP by Capros is 45 percent compared to 70 percent by Atorvastatin. However, Atorvastatin is more than three times as effective as Capros in reducing triglycerides. All the results were statistically significant and are shown in the graphs below:
In addition, the two placebo-controlled crossover studies in healthy human subjects, at a dose of 500 mg BID, were designed to assess the changes in cardiovascular parameters and aortic wave reflections induced by cold pressor stress test and mental stress test indicated that Capros may decrease arterial stiffness by decreasing the augmentation index, which indicates decreased wave reflections from the periphery and/or delayed return of the reflected wave.
In the above three studies, no serious side effects have been observed with Capros, as would be expected of a natural extract of a staple food item. Safety would be of paramount advantage with Capros compared to statins.
The potential of Capros is being further explored with additional studies with more subjects and higher doses.
2 Vijay Achari, AK Thakur, Arun K Sinha. Metabolic Syndrome – Its Prevalence and Association with Coronary Artery Disease in Type 2 Diabetes JIACM 2006; 7(1): 32-8.Review Article.
3 Assunta P et al .Chronic hyperglycemia and nitric oxide bioavailiability play a pivotal role in proatherogenic vascular modificatios.Genes & Nutrition.Volume 2, Number 2, 195-208, DOI: 10.1007/s12263-007-0050-5 Review.
4 Raja Babu Panwar, Rajeev Gupta, Bal Kishan Gupta, Sadiq Raja, Jaishree Vaishnav, Meenakshi Khatri & Aachu Agrawal. Atherothrombotic risk factors & premature coronary heart disease in India: A case-control study. Indian J Med Res July 2011, 134, pp 26-32.
5 Jousha A. Beckman M D. Pathophysiology of Vascular Dysfunction in Diabetes. December 2004 .Volume 8, Issue 10.
6 Maria Assuna Potneza, Sara Gagliardi, Carmela Nacci, Maria Rosaria Carratu and Monica. Endothelial Dysfunction in Diabetes: From Mechanism to Therapeutic Targets. Current Medicinal Chemistry, 2009, 16, 94-112.
7 Silvio E. Inzucchi, MD. Oral Antihyperglycemic Therapy for Type 2 Diabetes. Scientific Review and Clinical Applications. Journal of American Medical Association. January 16, 2002—Vol 287, No. 3.
8 Wright E, Jr.JL Scism-Bacon, and LC Glass. Oxidative stress in type 2 diabetes: the role of fasting and postprandial glycaemia Int J Clin Pract. 2006 March; 60(3): 308-314.
9 Antony B et al. A pilot clinical study evaluate the effect of Emblica officinalis extract (AmlamaxTM) on markers of systemic inflammation and dyslipidemia. Indian J. Clin. Biochemistry, 2008 23(4) 378-381.
167 Main St., #208
Brattleboro, VT 05301
Phone: (802) 257-5345
Sendara: Created Exclusively to Support Women’s Anti-Aging and Wellness
Women possess unique nutritional needs based on their agerelated, gender-specific, physiological requirements. As women age, it can create imbalances that may affect their appearance, health and well-being. The combination of aging, stress and hormonal changes may make women more susceptible to visible and physiological signs of aging that affect skin health, weight gain, cardiovascular function, mental cognition and immune support.
To address these issues, NutraGenesis has developed patent-pending Sendara®, a holistic, anti-aging nutraceutical that supports women’s wellness during the phases of a woman’s life. Sendara provides gender-specific nutritional components that optimize healthy age management for women by nourishing mind and body. It keeps women feeling and looking their best as they age by addressing the challenging results of stress, fatigue, menopause, cognitive deficits, weight management issues and metabolic dysfunction.
Sendara is composed of multipatented, standardized extracts of two of nature’s most revered ayurvedic botanicals. Sendara combines Sensoril, a clinically proven extract of ashwagandha (Withania somnifera) with Capros®, a clinically researched extract of the ultimate superfruit, Indian gooseberry (Phyllanthus emblica). Each botanical is a renowned adaptogen replete with anti-aging, anti-stress, and health restoring properties.
Reducing Cortisol and Stress
Women today experience greater levels of stress from the many roles they juggle in their daily lives. Cortisol is an Adrenal hormone produced in response to stress, as well as aging and menopause.1,2 It negatively affects a woman’s body by causing a number of health challenges including: anxiety, irritability, fatigue, sleeplessness, poor memory and concentration, food cravings, abdominal obesity and metabolic dysfunction. Medical professionals recognize that women’s health can benefit from reducing cortisol and stress during the many phases of a woman’s life.
A key aspect of Sendara’s ability to provide comprehensive health benefits for women is that it contains Sensoril, which possesses cortisol-lowering glycowithanolide bioactives.3 In a 60-day, randomized, double-blind, placebocontrolled clinical trial involving 98 subjects, consumption of the amount of Sensoril found in the recommended dose of Sendara reduced cortisol by 24. 2 percent.4 Subjects experienced reduced stress and stress-related factors, such as anxiety, irritability and difficulty sleeping. Improvements were also observed in subjects’ cognitive functions (memory and ability to concentrate), energy levels and mood.
In the trial, factors associated with metabolic and cardiovascular health also improved. Blood sugar levels decreased by 4.7 percent. LDL cholesterol and triglyceride levels dropped significantly. The level of Creactive protein, a systemic marker of inflammation also was reduced by 36.6 percent. These combined results demonstrate that Sendara can help women feel better while improving biochemical factors associated with improved health.
Supporting Healthy Weight Management
Sendara can also help women manage their weight. A major cause of overeating and weight gain in women is increased cortisol caused by stress, aging and menopause. Elevated cortisol levels often lead to greater cravings for calorie-laden comfort foods containing refined carbohydrates and fats.5 These foods stimulate brain chemicals like Serotonin that produce feelings of wellbeing. As a result of its cortisol-lowering properties, Sendara helps provide resistance to food cravings, snacking and overeating. Behavioral changes of this type may help women manage their weight for improved health.
Sendara also contains Capros, a standardized extract of Indian gooseberry. This polyphenol-rich super fruit contains low molecular weight hydrolysable tannins, which provide beneficial skin-rejuvenating, anti-aging, long-lasting antioxidant properties. These tannins protect the skin and body from agingassociated oxidative stress and enzyme degradation. When UV light (the No. 1 cause of premature skin aging) is absorbed by the skin, it can lead to wrinkling and dryness. This is because enzymes are produced that break down collagen and hyaluronic acid, which are components that add strength and moisture retention to the skin. In laboratory tests, Sendara inhibited collagenase and hyaluronidase, the enzymes that break down collagen and hyaluronic acid, illustrating its skin rejuvenating properties.6 Another consequence of UV light exposure of the skin is that iron is released from dermal storage proteins. This free iron causes accelerated production of free radicals in a process called the Fenton Reaction, which can lead to damage of dermal matrix components from the resulting oxidative stress. A HORAC assay demonstrated that Sendara inhibits UV-related oxidative stress in the skin by binding free iron with a superior iron chelation property, rendering the iron less harmful.6
1 Powell LH, et al. 2002. Psychosom Med 64:502-509.
2 Sapolsky RM, et al. 2000. Endocrine Rev 21(1):55-89.
3 Bhattacharya SK, et al. 1987. Phytother Res 1:32-37.
4 Auddy B, et al. 2008. JANA 11:50-56.
5 Dallman MF, et al. 2003. PNAS 100(20):11696-11701.
6 Proprietary testing conducted at an independent lab.
10 Henderson Dr.
West Caldwell, NJ 07006
Phone: (973) 882-7773
Natural Health Products Directorate of Heath Canada Conducts InDepth Review of Advantra Z/Bitter Orange
Based on the evidence reviewed, the botanical material bitter orange peel, at the doses typically used in herbal medicine and food, is not considered to pose any risk to the health of consumers.” This is the finding of “Synephrine, Octopamine and Caffeine Health Risk Assessment Report,” prepared by Robin Marles, PhD, director, Bureau of Clinical Trials and Health Sciences, Natural Health Products Directorate (NHPD) of Heath Canada. Health Canada is the Canadian counterpart to the U.S. Food and Drug Administration.
The 49-page health risk assessment report includes the most comprehensive and up-to-date clinical studies and scientific literature available on Advantra Z®/bitter orange, focusing on the dominant amine psynephrine and citing more than 160 references. It examines p-synephrine’s chemistry; new in vitro, animal and human studies; indepth review articles on the safety and efficacy of p-synephrine alone and in combination with caffeine; and a review of comparative adrenergic receptor binding studies of the isomers and enantiomers of p-synephrine and related protoalkaloids. There are also summaries of clinical case reports; and Canadian clinical case reports. Finally, the report addresses misconceptions and misinformation concerning the safety of psynephrine.
P-Synephrine—a stable synephrine isomer—is the dominant amine in Advantra Z, a patented bitter orange (Citrus aurantium) extract and the industry’s leading natural thermogenic ingredient. It is frequently combined with caffeine in weight loss, energy and sports nutrition products.
In response to the positive findings, the report establishes new dosing guidelines:
• 1 to 50 mg of p-synephrine per day for healthy adults is now classified as a Type III health risk: “a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.”
• Products providing up to 40 mg of p-synephrine in combination with a maximum of 320 mg of caffeine per day also have Type III classifications.
• Products containing greater amounts of these ingredients are now classified as Type II: “a situation in which use of, or exposure to, a product may cause temporary adverse consequences or where the possibility of serious adverse health consequences is remote.”
The report also states that Health Canada will require cautionary label statements on products containing more than 50 mg p-synephrine, noting that this dosage should be avoided by children, women who are pregnant and nursing, and people who take blood pressure and/or thyroid medications, sympathomimetics or monoamine oxidase inhibitiors (MAOIs).
Previously, Health Canada’s “Guidelines for the Use of Synephrine” limited daily intake of p-synephrine to 30 mg. Products containing both psynephrine and caffeine were prohibited without extensive human clinical studies.
The new report notes that some types of orange juice may contain 20-25 mg or more of p-synephrine in one 8- oz. Glass. It also states that although psynephrine- containing products have been implicated in adverse event case reports, “causality is not likely due to the p-synephrine content on its own, but rather due to other ingredients.”
The daily dosing guidelines and health risk classifications for poctopamine are identical to those for p-synephrine. P-octopamine is a protoalkaloid that is structurally and pharmacologically related to p-synephrine, and exists in citrus species as lemons (C. Limon), but is absent or present in only trace amounts in bitter orange extract.
To review “Synephrine, Octopamine and Caffeine Health Risk Assessment Report,” as well as other Advantra Z/bitter orange research studies, visit www.nutratechinc.com/advz and click on Scientific Research.
Distributed worldwide exclusively by Nutratech, Inc., Advantra Z is the industry’s leading, all-natural thermogenic ingredient, patent protected for stimulating thermogenesis, reducing weight, increasing the percentage of lean muscle, improving athletic performance and suppressing appetite.
OmniActive Health Technologies, Inc.
67 E. Park Pl., Ste. 500
Morristown, NJ 07960
Phone: (866) 588-3629
Fax: (877) 588-3629
Email: firstname.lastname@example.org • Website: www.omniactives.com
Capitalizing on Capsimax
Global obesity statistics are now all too familiar. With billions of people overweight and hundreds of millions obese, this epidemic weighs heavily on health care.12 Despite recent trends toward healthier diets and more frequent exercise, many people appear to be losing the battle of the bulge. Clearly, new strategies for weight management are needed, including those for appetite control, reduced fat and calorie absorption, increased thermogenesis (heat production) and increased lipolysis (fatty acid mobilization). The use of prescription drugs for these purposes is commonplace, though not without risk.4
Ingredients that boost thermogenesis are useful additions to weight management and sports nutrition formulas. While several ingredients are thermogenic, many have undesirable side effects, like increasing heart rate, raising blood pressure and interfering with sleep. The heat generated from chili (Capsicum annuum) is a preferred thermogenic agent, since it does not adversely affect metabolism or sleep. Indeed, capsaicinoids—the active principle in chili peppers—are associated with a variety of health benefits. For our purposes, there is an association between Capsicum consumption and a lower incidence of obesity.20 Yet, many people cannot tolerate the heat from doses required to produce such effects. Designed by nature to deter herbivores and fungi, capsaicinoids also deter many humans, especially at pharmacologic doses. The challenge was to make an extract to be taken conveniently as a supplement, while not causing irritation to consumers. Capsimax™ is a red pepper extract that uses novel delivery technologies to mask the irritating effects of capsaicinoids.
The evidence linking capsaicinoids to weight management is compelling.1 During the past 30 years, in vivo and in vitro studies conducted on capsicum and its extracts have elucidated their metabolic effects and mechanisms.18 Specifically, red chili pepper, or its Extract, has been shown to reduce appetite, increase diet-induced thermogenesis, increase lipolysis and improve body composition. Diet-induced thermogenesis— wherein calories are expended as heat rather than converted to fat— increased significantly in human subjects after a meal containing capsicum. 15,22,23 Increased lipolysis after capsaicinoid intake has also been reported in animals10 and humans2,10,22, suggesting it may aid in body fat loss. Capsaicinoids have also been shown to reduce food intake in animals.21,23,24
In a randomized, placebo-controlled, double-blind, cross-over study, subjects ingesting 100 mg of Capsimax (2 mg capsaicinoids) showed a significant increase in serum free fatty acids and glycerol (byproducts of lipolysis) at selected time intervals post ingestion. Capsimax also increased blood catecholamine levels without significant changes in heart rate or blood pressure compared to placebo, thus supporting its safety.2 These doses were also well tolerated. Indeed, capsaicinoid doses from 3-10 mg have been used in studies with little or no adverse outcomes. By incorporating a novel beadlet technology that delivers optimum doses, while avoiding the oral and gastric irritation associated with hot red pepper, Capsimax brings safety and tolerability to another level.6
Either alone or in combination with other ingredients, capsaicinoids can improve body composition.8,9 In animals and humans, capsaicinoid ingestion reduced body fat and improved insulin resistance.7 Supplements containing capsaicin and green tea extract significantly enhanced body fat loss in one human clinical study.19 Capsimax Plus™—a dietary blend of capsaicinoids, niacin, piperine and caffeine— was shown to increase calories burned before, during and after moderate exercise in a randomized, placebo-controlled clinical trial (unpublished data). Thus, Capsicum consumption promotes negative energy balance, especially in synergy with other agents.13
The biochemistry of capsaicinoid action is complex. Thermogenesis is stimulated by activating and uncoupling sarcoplasmic reticulum Ca+-ATPase to increase heat energy production.14 Capsaicinoids may also stimulate vasodilation, which indirectly impacts thermogenesis. 3 They also stimulate transient receptor potential vanilloid subfamily member 1 (TRPV1), which releases substance P, a neurotransmitter that activates neurokinin-1. This results in activation of the sympathetic nervous system and release of the catecholamines epinephrine and norepinephrine from the adrenals. These stimulate hormone-sensitive lipase and mobilization of fatty acids to undergo oxidation5, and are also responsible for reduction in appetite.17 By reducing lipogenic enzyme activity and increasing hormone- sensitive lipase activity, capsaicinoids help improve fat metabolism.16
In summary, there is solid support for increased thermogenesis, lipolysis and appetite control with capsaicinoids. Capsimax goes beyond typical human capsaicinoid intakes, allowing researchers to optimize the dose used in clinical trials, and to combine it conveniently with other weight-management ingredients. In this light, insights into appetite control, lipolysis and thermogenic mechanisms can be further studied, and results optimized with continuing research.18
1 Bloomer RJ, Canale RE, Fisher-Wellman KH. The potential role of capsaicinoids in weight management. AgroFood Industry Hi-tech 2009;20:60-2.
2 Bloomer RJ, Canale RE, Shastri S, et al. Effect of oral intake of capsaicinoid beadlets on catecholamine secretion and blood markers of lipolysis in healthy adults: a randomized, placebo controlled, double-blind, cross-over study. Lipids Health Dis. 2010;9:72.
3 Fragasso G, Palloshi A, Piatti PM, et al. Nitric-oxide mediated effects of transdermal capsaicin patches on the ischemic threshold in patients with stable coronary disease. J Cardiovasc Pharmacol. 2004;44:340-7.
4 Idelevich E, Kirch W, Schindler C. Current pharmacotherapeutic concepts for the treatment of obesity in adults. Ther Adv Cardiovasc Dis. 2009;3:75-90.
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LeanGard: A Clinically Proven Choice for Weight Management
LeanGard® is Sabinsa Corporation’s proprietary blend of GarCitrin®, ForsLean® and BioPerine®, with the suggested use level of 500 mg twice daily. Composition of LeanGard and its bioactive ingredients is as follows:
• GarCitrin (25 to 30 percent Hydroxycitric Acid + 2-3 percent Garcinol)
• ForsLean (4-5 percent Forskolin)
• BioPerine (0.3-0.5 percent Piperine) The key advantage of LeanGard is that it combines two different groups of bioactive ingredients with complementary mechanisms of action for weight management.
As far as GarCitrin is concerned, hydroxycitric acid (HCA) causes inhibition of fatty acid synthesis and stimulation of fatty acid oxidation (ß oxidation). This is done via competition of HCA with citrate for the enzyme citrate lyase. HCA also suppresses appetite. Garcinol modulates regulatory cell signal pathways and, therefore, facilitates the uptake of HCA into the cells.
As far as ForsLean is concerned, Forskolin facilitates production of cyclic adenosine monophosphate, or cAMP, which in turn facilitates the action of various hormonal and bioactive substances in the body (such as insulin and thyrotropin) leading to increase in the metabolic rate and thermogenesis, and buildup of lean body mass. CAMP also leads to subsequent activation of protein kinase leading to breakdown of triglycerides, and decrease in body fat.
As far as BioPerine is concerned, it is a clinically proven, natural bioavailability- enhancer for nutrients.
BioPerine, a standardized extract obtained from black pepper, is a selfaffirmed GRAS (generally recognized as safe) substance with the recommended use level of 5 mg/dose.
Sabinsa Corporation conducted a clinical trial to investigate the efficacy and safety of LeanGard with following parameters:
• Design: placebo-controlled, randomized, double-blind, parallel-group
• Subjects: 50 overweight subjects in each group comprising of 24 men and 26 women ranging in age from 25 to 55 years
• Study Duration: 12 weeks
• Dosage: 500 mg of the LeanGard or placebo, twice a day
The study suggested that LeanGard caused 7.5 percent reduction in the body weight, 8.15 percent reduction in the body fat and 4.36 percent increase in the lean body mass of the test group compared to negligible values for the placebo group. Furthermore, LeanGard did not cause significant changes in blood pressure, heart rate, hematological parameters, liver function, renal function, thyroid function and plasma lipid levels.
Based on the results of above clinical trial, LeanGard is considered an effective and clinically safe dietary supplement in support of weight management. LeanGard should be considered complimentary to, not substitute for, sensible diet and exercise.