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Science Of Supplements: Winter Issue

K2VITAL®
 
Albion Minerals®

An annual feature since 2002, this special section of Nutrition Industry Executive (NIE) is designed to help manufacturers gain a better understanding of the ingredients and services available that can make their products stand out. It gives the magazine’s advertisers an opportunity to describe in detail the research that goes into their branded ingredients, products and company services.

The key difference for 2011 is that NIE is responding to the increased demand for science and research by offering this section twice—first in April (the Summer Issue) and then again in November (the Winter Issue)—providing our advertisers with two Science of Supplements opportunities to describe their efforts to our readers.

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, e-mail and website addresses to make obtaining additional information as easy as possible.

Following is an index of companies participating in the Winter NIE Science of Supplements section:


Chemi Nutra

4463 White Bear Pkwy., Ste. 105
White Bear Lake, MN 55110
Phone: (866) 907-0400
Website: www.cheminutra.com

A-GPC: Demonstrated Benefits for Memory, Reaction, Alertness, Fatigue and Focus

Alpha-GPC is a Crucial Building Block of Acetylcholine 
Alpha-glyceryl phosphoryl choline (AGPC), derived from natural, high phosphatidylcholine (PC) soy phospholipids, is a nutrient that occurs naturally in the human body, where it is involved in a multitude of very crucial biochemical functions. Phosphorylcholine, formed from A-GPC, migrates to the synaptic nerve endings found throughout the entire central nervous system, and in turn increases the synthesis and release of acetylcholine (AC). AC is a vastly important neurotransmitter present in both brain and muscle tissue.1 In the brain, AC plays a key role in basically every cognitive function, while in muscle it is vitally involved in muscle contraction.

A-GPC Vitally Impacts Neuron to Neuron Communication 

A-GPC provides a rapidly absorbed form of choline 

that has been shown to raise free plasma choline levels faster than other choline precursors.2 These health benefits extend to cognitive function and dementias, healthy aging, exercise performance and hormone health, and are supported by an abundance of published scientific and clinical studies involving both humans and animals.3 Acetylcholine and Improved Muscular Performance It has been demonstrated through scientific study that engaging in intense exercise can cause a significant reduction in plasma choline levels, thus reducing global stores of AC, and causing a negative impact on endurance and muscular performance. Thus, A-GPC can enhance essentially all physical movements— explosive power output, agility, jumping ability—since muscle contraction is related to available AC stores, and because A-GPC maximizes AC.

Acetylcholine, Growth Hormone and Health 

AC has been shown to potentiate the secretion of human growth hormone (HGH), a master hormone that in part regulates basal metabolism and body composition. Since A-GPC has been shown to naturally increase AC, it offers additional health benefits realized by increasing HGH.4 Since the intrinsic release of HGH declines significantly after adolescence, boosting HGH can improve resistance to illness, vitality, recovery, muscle mass gains, decreases in fat mass and improvements in sleep patterns.

Recent Research Involving A-GPC: Influence on Reaction Time, Alertness, Fatigue and Focus

A very exciting placebo-controlled, double-blind, human study was recently performed to explore A-GPC administration and reaction time, alertness, energy, fatigue and focus, compared to a placebo. Nineteen physically active subjects were randomly assigned to a group that either consumed a supplement containing 150mg AlphaSize® AGPC or placebo.

Afterward, the subjects were asked to complete a short questionnaire describing feelings of energy, fatigue, alertness and focus. Then the subjects engaged in four-minute quickness and reaction tests on a Makoto testing device. Next, the subjects performed a 10-minute exhaustive exercise bout that included a 30-second Wingate Anaerobic Power Test, followed by performing a maximum number of pushups and sit-ups in one minute. Finally, subjects repeated the questionnaire and reaction testing sequence with the Makoto testing device.

Synopsis of Findings: A-GPC Manintaned Reaction Performance to Both Visual and Auditory Stimuli Following a High-Intensity Bout of Exhaustive Exercise 

Subjects who consumed the A-GPCcontaining supplement maintained time performance between pre- and postmeasures, while a significant decline between pre- and post- measures were observed in subjects consuming the placebo. In summary, acute A-GPC supplementation resulted in the ability of subjects to maintain focus and alertness following an acute bout of exhaustion, while subjects consuming the placebo realized significant declines in both focus and alertness.5 

Alphasize A-GPC is a Natural, Safe, GRAS Ingredient 
AlphaSize A-GPC is tasteless, watersoluble and extremely stable natural GRAS ingredient, and it offers excellent performance in all solid and liquid applications in dietary supplements, functional foods and medical foods.

References: 

1 Jager, R, Purpura, M, and Kingsley, M. Phospholipids and sports performance.J Int Soc Sport Nut 4: 5-28, 2007.

2 De Jesus Moreno M., “Cognitive improvement in mild to moderate Alzheimer’s dementia after treatment wi5th the acetylcholine precursor choline alfoscerate: A multicenter, double-blind, randomized, placebo-controlled trial.” Clin. Therapeutics 2002;25:178-193.

3 Parnetti L. et al., “Cholinergic precursors in the treatment of cognitive impairment of vascular origin: Ineffective approaches or need for re-evaluation?” Jour. Neur. Sci., 257 (2007) 264-269.

4 Ceda GP, et al. “Effects of an acetylcholine precursor on GH secretion in elderly subjects.” In: Bercu, BB, Walter, RF, eds. Growth Hormone II: Basic and Clinical Aspects. Springer-Verlag; 1994.

5 Hoffman, J., et al. The effects of acute and prolonged CRAM supplementation on reaction time and subjective measures of focus and alertness in healthy college students. J International Soc Sport Nut 7:39, 2010.


CONNOils LLC

P.O. Box 357
Big Bend, WI 53103
Phone: (262) 662-5533
Fax: (262) 662-2828
e-Mail: stacy@connoils.com • Website: www.connoils.com

Soy Lecithin and the Choline Connection

CONNOils is proud to offer soy lecithin for manufacturers in the natural products industry. Supporting the body from head to toe, lecithin is ideal for a number of applications—functional foods, supplements, even cosmetics, where it’s an integral ingredient in everything from shampoos to lipsticks. Soybeans are the primary commercial source of lecithin.

Soy lecithin’s importance can be traced to its high level of phosphatidylcholine, an important source of choline. The value of this latter nutrient cannot be overstated. It is essential for the structural integrity of cell membranes, signaling in the nervous system, body cell function/ carbon metabolism, and lipid-cholesterol transport and metabolism.1 The bioavailability of choline speeds the synthesis and release of acetylcholine, an important nervous system-signaling molecule involved in numerous important functions throughout the body (e.g., learning and memory).

Acetylcholine release may be reduced by strenuous exercise, which could ultimately lead to reduced endurance and performance.2 Reduced amounts of free choline have been associated with weakened impulse transmission and impaired performance in skeletal muscle.2 If the muscle cell membranes are depleted of phospholipids, these cells may not endure as much mechanical stress.3 Therefore, it is possible that supplementing with choline or lecithin during exercise could benefit individuals engaged in strenuous activities.4 

Evidence indicates that choline deficiency may also be associated with negative health consequences in the liver, blood vessels and neurological tissue.5 In fact, it could be said that the sooner one takes choline, the better.

Preclinical studies have shown that perinatal supplementation of choline enhances memory and learning functions. More importantly, these changes endure across the lifespan.6 Choline is critical during fetal development as it influences stem cell proliferation and apoptosis.7 Researchers discovered that low levels of maternal choline indicated a risk factor for neural tube defects; higher levels were deemed a protective factor.8,9 

Animal studies also revealed stunning benefits. Supplementing the maternal diet with excess choline during pregnancy and lactation dramatically improved attention function of the adult offspring in a mouse model of Down syndrome.10 Rat pups that received choline supplements through their mother (i.e., in utero and for two weeks after birth) had enhanced brain function that resulted in lifetime memory enhancement.11 Animals whose mothers had extra choline continued to show improved memory even when the offspring were older. The conclusion: having adequate choline early in development may be critical for improved longterm memory.11 

To learn more about the science behind soy lecithin and choline, visit CONNOils’ website (www.connoils.com) or call (262) 662-5533.

References: 

1 Zeisel SH, Blusztajn JK. Choline and human nutrition. Annu Rev Nutr 1994;14:269-96.

2 Conlay LA, Sabounjian LA, Wurtman RJ. Exercise and neuromodulators: choline and acetylcholine in marathon runners. Int J Sports Med 1992; 13 Suppl 1:S141-2.

3 da Costa KA, Badea M, Fischer LM, Zeisel SH. Elevated serum creatine phosphokinase in choline deficient humans: mechanistic studies in C2C12 mouse myoblasts. Am J Clin Nutr 2004; 80:163-70.

4 Penry JT, Manore MM. Choline: an important micronutrient for maximal endurance-exercise performance. Int J Sport Nutr Exerc Metab 2008; 18:191-203.

5 Li Z, Vance DE. Phosphatidylcholine and choline homeostasis. J Lipid Res 2008; 49:1187-94.

6 Zeisel SH. The fetal origins of memory: the role of dietary choline in optimal brain development. J Pediatr 2006; 149:S131-6.

7 Zeisel SH. Choline: critical role during fetal development and dietary requirements in adults. Annu Rev Nutr 2006; 26:229-50.

8 Shaw GM, Finnell RH, Blom HJ, et al. Choline and risk of neural tube defects in a folate-fortified population. Epidemiology 2009; 20:714-9.

9 Shaw GM, Carmichael SL, Yang W, Selvin S, Schaffer DM. Periconceptional dietary intake of choline and betaine and neural tube defects in offspring. Am J Epidemiol 2004; 160:102-9.

10 Moon J, Chen M, Gandhy SU, et al. Perinatal choline supplementation improves cognitive functioning and emotion regulation in the Ts65Dn mouse model of Down syndrome. Behav Neurosci 2010; 124:346-61.

11 Zeisel SH. Choline: needed for normal development of memory. J Am Coll Nutr 2000; 19:528S-31S.


ESM Technologies

2213 Missouri Ave.
Carthage, MO 64836
Phone: (866) 804-8034
Fax: (866) 907-5061
Website: www.esmingredients.com

Natural Eggshell Membrane for Joint Support

Joint comfort is important to all of us. Basic movement necessary to engage in normal activities depends upon joint flexibility without pain. Unfortunately, an active lifestyle, excess weight, genetics and the aging process are all factors that can put stress on our joints.Consequently, dietary supplement products addressing joint health are prevalent within the natural products industry.Most of these products contain glucosamine, chondroitin or both, frequently in combination with other dietary ingredients, such as MSM, hyaluronic acid and various anti-inflammatories.Many of these ingredients have been extensively studied and the results have been generally positive.

Natural Eggshell Membrane (NEM®) derived from the inner membrane of chicken eggshells, is an alternative choice for supporting joint health. NEM is a unique, naturally occurring source of several important glycosaminoglycans, including chondroitin sulfate and hyaluronic acid, as well as collagen and other important proteins and amino acids that are integral to joint health.More importantly, the research support for NEM is impressive, not only because it works as well as or better than other ingredients in this category, but because it offers some distinct advantages.

The results from two open-label studies demonstrated the positive effects of NEM in ameliorating the joint pain and stiffness associated with damage to joints and the surrounding connective tissue.Both studies evaluated levels of pain and one study also evaluated improvements in range of motion. In both studies a single daily 500mg dose of NEM found in Membrell’s JOINThealth, resulted in a significant response in as few as seven days of treatment.

In a separate randomized, multicenter, double-blind, placebo-controlled clinical study, 500mg 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 which should be particularly important, not only for individuals with arthritis, but also for those who regularly engage in sports or other athletic activities and experience the joint discomfort, inflammation and stiffness resulting from frequent joint motion.

Another finding from this study was the NNT, or number needed to treat. NNT is used in clinical practice to measure therapeutic effectiveness in treating a particular affliction, such as reducing pain from arthritis. The lower the NNT, the better the treatment modality. The NNT for NEM was 5.0 (60 days), meaning that one out of every five patients should experience at least a 50 percent reduction in pain within 60 days. NEM’s NNT was much better than the NNT for celecoxib(14. 9, 13 weeks) and was nearly five times better than a combination of glucosamine/ chondroitin (23.8, six months).The NNT values for NEM in reducing stiffness, measured at 10, 30 and 60 days, were equally as striking, especially at 60 days when the NNT was 2.4. 

It is noteworthy that all of these studies utilized a relatively small single 500mg dose of NEM. In comparison, the therapeutic dose for glucosamine products is 1,500mg, typically split into three 500mg doses. The recommended dosing for chondroitin is 1,200mg, also split between three 400mg or two 600mg doses. From a convenience standpoint, NEM provides a preferable option. In addition, the most recent large studies have called into question the therapeutic value of glucosamine and chondroitin.

The safety profile for NEM is significant as well. Even after long-term use, there are no known side effects with the exception of the obvious egg allergy concern. This is especially important for individuals who have conditions that warrant extended use, as well as for those who want to remain active into middle age and beyond.

NEM can be used by ovo-vegetarians, as it is derived from a domestic renewable source and is free from contaminants.It is clinically proven to enhance comfort and flexibility, naturally replenish joint and connective tissue nutrients, and promote faster recovery from exercise and competition. Whether the goal is managing the discomfort associated with aging joints or supporting the active lifestyle of the sports enthusiast, a product containing NEM could not only be the best choice, but also the obvious choice.

References: 

Ruff KJ, DeVore DP, Leu MD, Robinson MA. “Eggshell membrane: a possible new natural therapeutic for joint and connective tissue disorders. Results from two openlabel 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).

Http://www.mayoclinic.com/health/glucosamine/ NS_patient-glucosamine/DSECTION= dosing.

Icon Group, LLC

167 Main St., #208
Brattleboro, VT 05301
Phone: (802) 257-5345
Fax: (802) 251-6981
e-Mail: info@icongroupllc.com • Website: www.icongroupllc.com

Synetrim CQ Provides Three-Way Weight Management in One Ingredient 
By Dr. Bruce Abedon, director of scientific affairs

According to recent Centers for Disease Control figures, 68 percent of American adults are overweight or obese.Obesity-related health issues such as metabolic syndrome, diabetes and cardiovascular disease are becoming more common, and consumers seeking healthy solutions to manage their weight and improve their overall health are increasingly rejecting costly, unsafe pharmaceuticals. Instead they are choosing healthy diet and lifestyle changes accompanied by supplementation with efficacious, all natural products derived from botanicals, which have comprehensive safety profiles.

Synetrim CQ is a Clinically Proven Weight Management Ingredient 

SynetrimCQ® is an all natural, multipatented, standardized extract of Cissus quadrangularis, a botanical with a long history of human consumption in India and West Africa for culinary and medicinal uses. This novel, branded ingredient helps reduce body fat while contributing to overall metabolic health via a variety of unique weight management mechanisms of action. Synetrim CQ is the only extract of Cissus quadrangularis that is patented for weight loss.

The multi-dimensional weight management benefits of Synetrim CQ have been demonstrated in multiple randomized, double-blind, placebo-controlled human clinical trials. In a 10-week trial involving 48 subjects, Synetrim CQ consumption resulted in significant reductions (Figure 1) in weight (19.2 lbs.), body fat (14.6 percent) and waist size
3. 4 inches). Significant weight loss was also observed in subjects participating in a different six-week trial.

Synetrim CQ Possesses Triple Action Digestive Enzyme Blocking 

Synetrim CQ uniquely reduces absorption of dietary fat, carbohydrates and starchderived sugar in one comprehensive ingredient. Synetrim CQ reduces the activity of enzymes responsible for digesting these dietary components, which lowers the caloric contribution of these nutrients to weight gain. This novel tripleaction mechanism helps inhibit the activity of the fat-digesting enzyme, lipase, as well as á-amylase and á-glucosidase, enzymes that break down starch carbohydrates as well as starch-derived sugar.

Synetrim CQ Helps Balance Blood Sugar Levels 

Glycemic index is a measure of how fast glucose enters the bloodstream after a meal. Starch-rich processed foods have a high glycemic index because they are rapidly digested by á-amylase and á-glucosidase.The sudden spike in post-meal blood glucose levels can lead to fat deposition and weight gain. By reducing the activity of these enzymes, Synetrim CQ helps lower spikes in serum glucose for enhanced healthy weight management.In fact, in the 10-week clinical trial, ingestion of Synetrim CQ resulted in significant reductions in blood sugar levels.

Synetrim CQ is Clinically Proven to Help Improve Blood Lipid Levels 

Synetrim CQ contains plant sterols called photogenic ketosterones. Studies indicate these sterols block absorption of cholesterol from the digestive tract, resulting in reduced serum cholesterol levels for improved cardiovascular health. In both the six- and 10-week clinical trials, Synetrim CQ consumption resulted in significantly lower levels of total cholesterol by the end of each study. LDL cholesterol and triglycerides were also reduced.

Synetrim CQ Helps Enhance Mood and Increase Satiety by Raising Serotonin Levels 

People trying to lose weight often become irritable. Ironically, this can cause additional weight gain because research indicates that stress and irritability often lead to overeating and cravings for calorie- rich comfort foods. These cravings can result from reduced levels of serotonin, a neurotransmitter that affects mood and satiety. Snacking helps improve a person’s mood because these foods temporarily raise serotonin levels. Synetrim CQ helps enhance mood by elevating serotonin levels, as was demonstrated in the six-week trial, which may help reduce stress-related overeating.

Synetrim CQ Possesses a Comprehensive Safety Profile 

All natural Synetrim CQ has an extensive safety record and is well tolerated with no adverse effects reported in multiple human clinical trials and acute toxicity studies. Icon Group is a leading provider of patented, all natural, clinically tested weight management ingredients that enhance human health. The company’s ingredients feature market-ready substantiated structure/function claims in a number of leading condition-specific areas including: weight management, satiety, appetite control, thermogenesis, cardiovascular health, blood sugar balance, mood enhancement, metabolic balance/ wellness and inflammation response.

References: 

Jainu M and CSS Devi. Afr J Biomed Res. 2005;8:95-99.

Mishra G, et al. Int J PharmTech Res. 2010;2(2):1298-1310.

Oben J, et al. Lipids Health Dis. 2006;5:24-40.

Oben JE, et al. Lipids Health Dis. 2007;6:4-26.

Oben JE, et al. Lipids Health Dis. 2008;7:12-23.

Sathyaprabha G, et al. J Pharm Res. 2010;3(12):2970-2973.

Shah U. Int J Pharm Pharmaceut Sci.2011;3:Suppl 4.

Sharp H, et al. Nat Prod Comm. 2007;2(8):817-822.


InnoVactiv

2 St. Germain St. E., Ste. 200
Rimouski, QC, Canada G5L 8T7
Phone: (418) 652-9598
Fax: (418) 652-7418
e-Mail: info@innovactiv.com • Website: www.innovactiv.com

InSea2: Recent Publications Confirm Dual-Action Mechanism

Physiologists will say that sugar is essential to maintain proper body functions.Our body’s main use of sugar is as an energy source. But just how much sugar do we need?

The Dietary Guidelines for Americans recommends that about 45 to 65 percent of our energy comes from carbohydrates.1 However, consumption of added sugar has risen to alarming levels in recent years. From 1970 to 2005, annual sugar consumption increased by 19 percent, adding 76 calories to the daily diet of Americans2, enough to add about seven pounds of body weight every year!

The fact is that now almost every food product contains hidden sugars. It is no surprise then to learn that the average American consumes over 71 pounds of added sugar each year.2 

When carbohydrates are ingested, most of them are not in a state where they can pass into the bloodstream. This is the case for large starch molecules as well as for table sugar. The intestine secretes two digestive enzymes (called á-amylase and á-glucosidases) that cut carbs into smaller pieces, making them ready for absorption.

Research has recently shown that some sugars and carbs have a very high impact on our blood glucose, while others don’t. Carbs that are rapidly digested and absorbed, such as table sugar, provoke a sharp increase in postmeal blood glucose and insulin.Those carbs have a high glycemic index (GI). For diabetic patients, the impact of eating those carbs is a challenge in the daily management of their condition. For nondiabetics, elevated blood glucose levels coming from high GI carbs are associated with an increased risk of developing heart diseases3, or diabetes4. Carbs that are digested at a slower pace (low GI) have a lesser impact on blood glucose and insulin, making them a preferable choice for people concerned about their blood glucose levels.But how to choose the right carbs, when there’s so much added sugars everywhere? Here’s help from Mother Nature that will ensure we make the right choice every time.

InSea2 is the first and only dualaction carb blocker. It is a polyphenol- rich extract coming from wildcrafted brown seaweeds. It works by inhibiting á-amylase and á-glucosidases (more specifically sucrase) within the gut. By doing so, InSea2 offers a natural, safe and effective solution for those concerned with starch and sugar intake or looking for a natural help to maintain their blood sugar metabolism in an optimal state.

A first paper featuring in vitro experiments showing the unique dual mechanism of action of InSea2 against á-amylase and á-glucosidase enzymes, as well as results demonstrating the carb-blocking effect of InSea2 in laboratory animals was accepted for publication in Food Research International5, a journal of the Canadian Institute of Food Science and Technology. Unpublished data also demonstrated that InSea2 possesses more inhibitory activity against sucrase, and was as a consequence able to minimize the rise in blood sugar caused by common table sugar.

A second publication presented results from a recent human clinical trial that confirmed the efficacy of InSea2 to help stabilize blood sugar and insulin response following a meal (see figure).Following intake of 500mg of InSea2 and 50g of carbohydrates, healthy volunteers experienced a statistically significant 48 percent reduction in blood glucose response when using InSea2 (P=0.04) over placebo. Overall insulin secretion was reduced by 12 percent (P=0.02) and the Cederholm Index of insulin sensitivity was increased by eight percent in (P=0.047). The results from this study have been accepted for publication in Applied Physiology, Nutrition and Metabolism, and were presented orally at the Experimental Biology meeting.6 

For more information on InSea2, visit www.innovactiv.com, send an e-mail to info@innovactiv.com or call(418) 652-9598 ext. 252.

References: 

1 U.S. Department of Health and Human Services and U.S. Department of Agriculture. Dietary Guidelines for Americans, 2005. 6th Edition, Washington, DC: U.S. Government Printing Office, January 2005.

2 Johnson RK, et al. American Heart Association Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism and the Council on Epidemiology and Prevention. Dietary sugars intake and cardiovascular health: a scientific statement from the American Heart Association. Circulation. 2009 Sep 15;120(11):1011-20.

3 DECODE Study Group, European Diabetes Epidemiology Group. Is the current definition for diabetes relevant to mortality risk from all causes and cardiovascular and noncardiovascular diseases? Diabetes Care. 2003 Mar;26(3):688-96.

4 Salmerón J, et al. Dietary fiber, glycemic load, and risk of non-insulindependent diabetes mellitus in women. JAMA. 1997 Feb 12;277(6):472-7.

5 Roy MC, et al. Effect of a commercially- available algal phlorotannins extract on digestive enzymes and carbohydrate absorption in vivo. Food Research International, In Press.

6 Lamarche B, et al. Study of the acute impact of polyphenols from brown seaweeds on glucose control in healthy men and women. Annual Meeting of FASEB, April 2010, Anaheim, CA.


InterHealth Nutraceuticals

5451 Industrial Way
Benicia, CA 94510
Phone: (800) 783-4636
Fax: (707) 751-2801
e-Mail: info@interhealthusa.com • Website: www.interhealthusa.com

Merastin: Clinically Proven Weight-Management Ingredient

Merastin™ is a proprietary blend of two plant extracts, Sphaeranthus indicus flower heads and Garcinia mangostana fruit rind. Each plant contributes essential components to Merastin’s ability to affect multiple pathways involved in fat formation and fat breakdown for ultimate weight management benefits. The safety and efficacy of Merastin in the management of body weight was evaluated in two randomized, double-blind, placebo-controlled studies.

Clinical Research Demonstrates Reduction in Weight, Waist and Hip Size 

Pooled data from two randomized, double- blind, placebo-controlled studies compared the weight-loss effects of 800mg of Merastin or a placebo on 95 people (average weight = 180.1 lbs; BMI = 33.5 kg/m2) for eight weeks.Study participants took either 400mg of Merastin or placebo twice daily (30 minutes before breakfast and dinner).Merastin significantly reduced body weight, waist and hip size in two weeks, reducing body weight by 4.5 lbs; waist by 4.7 inches and hip by 2.5 inches. By the end of the study, Merastin significantly reduced body weight by 11.5 pounds and waist and hip size by 4.7 inches and 2.5 inches, respectively. The difference between the placebo and the Merastin results were statistically significant.Merastin was also shown to help burn fat and support healthy adiponectin levels. Figures presented here in this article represent eight-week results from one of the Merastin clinical studies used in the pooled analysis. In this clinical study, Merastin significantly reduced body weight by 11.2 lbs., waist size by 4.66 inches and hip size by 2.57 inches. Twoweek data from this study also demonstrated significant findings for both weight loss and waist size reduction.

Study participants in both studies walked 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. By taking this approach, the researchers addressed, as well as avoided, the well-documented failure of individuals adhering to their diet restrictions. Therefore, the researchers believe that the results derived from the Merastin studies are more readily applicable to real-life weight loss scenarios, and emphasize the need to combine a healthy lifestyle change that includes improved nutrition and moderate increases in physical activity together with Merastin supplementation to achieve optimal results.

Supporting Efficacy 

In vitro studies on Merastin demonstrated modulating effects on several biomarkers and biochemical parameters involved in fat formation and fat breakdown. Animal research demonstrated enhanced weightmanagement effects. The effects of Merastin on reducing body weight were also investigated in high fat diet-induced rat model. After eight weeks, Merastin prevented body weight gain more than eight-fold as compared to animals fed an identical diet plus placebo.1


Comprehensive Safety Profile on Merastin Demonstrates Wide Margin of Safety 

Merastin is derived from plants, a fruit and a flower, traditionally used in Southeastern Asian culture. Clinical research demonstrates no side effects attributed to the blend. A comprehensive safety profile on Merastin, including a 90-day broad-spectrum safety evaluation, indicates no observed adverse effect (NOAEL) and the maximum tolerated dose (MTD) exceed 5,000mg/kg body weight a day.1

Merastin is easily incorporated into weight management products. The ingredient offers a twice-a-day convenient dose that has been clinically shown in two randomized, double-blind, placebo- controlled studies to decrease body weight, waist and hip size in two weeks with even greater benefits seen at eight weeks. Two clinical studies demonstrating significant weight management benefits offers a chance to establish a Oral Refresh™ stimulates and supplements saliva, a vital component in maintaining a healthy mouth. Saliva acts as a moisturizing lubricant to protect the mouth from abrasion and to aid in swallowing. This fluid also works to wash away many microorganisms before they adhere to oral surfaces. In addition, saliva contains specific compounds, which act as antimicrobial agents. Unfortunately, many of us do not secrete enough saliva to reap its inherent benefits. Whether due to aging, medication, smoking or other factors, a dry mouth can have a serious impact on our oral health.

Oral Refresh is a unique combination of enzymes, proteins, probiotics, antioxidants and xylitol that helps stimulate and replenish the production of saliva. These ingredients work synergistically with saliva to help maintain a healthy mouth.

Oral Refresh provides lactoferrin, lactoperoxidase and lysozyme. The supplemental use of lysozyme, lactoferrin and lactoperoxidase to support oral health has been the subject of research for over 30 years. Lactoferrin is an antimicrobial protein that participates in defending the body from microbial invasion. Lysozyme is an antimicrobial enzyme that destroys the cell walls of cariogenic bacteria and fungi.Lactoperoxidase is an enzyme that catalyzes the oxidation of various substrates by hydrogen peroxide creating antimicrobial compounds. These proteins work synergistically with saliva’s enzymes to defend against bacterial, viral and fungal pathogens. Recent studies with oral products containing the combination of these enzymes showed significant improvement in the symptoms of dry mouth with 32 percent of subjects reporting major improvement. The benefits of lactoferrin in maintaining oral health were further supported in a recent human trial. The study evaluated oral administration of lactoferrin and its beneficial effect on periodontal disease.

Oral Refresh also provides a natural source of thiocyanate from alfalfa, which is transformed by salivary peroxidases into the potent antimicrobial compound hypothiocyanite. The interaction between thiocyanate and salivary peroxidases is a natural part of a healthy oral system.

Oral Refresh also supplements the probiotic Lactobacillus salivarius. This probiotic has been shown to have beneficial effects in maintaining oral health, from reducing bad breath to positively impacting the microflora of the mouth. A 2008 randomized, double- blind, placebo-controlled study investigating the effect of L. salivarius on periodontal parameters concluded that the probiotic was useful in the maintenance of oral health.

In addition, xylitol is a non-caloric sweetener. A common ingredient in sugar-free gums and candies, xylitol offers no energy source for oral pathogens. Xylitol also stimulates salivary flow and recent studies indicate that regular use supports the reduction of cariogenic bacteria. One recent study compared the effects of xylitol supplements in children on both cavity- causing Streptococcus mutans and beneficial Lactobacillus spp. The study concluded that while S. mutans populations were reduced, the number of Lactobacillus spp remained virtually unchanged.

References: 

Dirix et al. Efficacy of the BioXtra dry mouth care system in the treatment of radiotherapy-induced xerostomia. Support Care Canc 2007 Dec; 15(12);1429-36.

Ihalin et al. Origin, structure, and biological activities of peroxidases in human saliva. Arch Biochem Biophys 2006 Jan 15; 445(2)-261-8.

Ishikado et al. Human trial of liposomal lactoferrin supplementation for periodontal disease. Biol Pham Bull 2010; 33(10);1758-62.

Ly et al. Xylitol gummy bear snacks: a school-based randomized clinical trial. BMC Oral Health 2008; 8:20.

Shimauchi et al. Improvement of periodontal condition by probiotics with Lactobacillus salivarius WB21: a randomized, double-blind, placebo-controlled study. J Clin Periodontol 2008 Oct; 35(10):897-905.


Natreon

2D Janine Pl.
New Brunswick, NJ 08901
Phone: (732) 296-1080
Fax: (732) 296-1075
e-Mail: info@natreoninc.com • Website: www.natreoninc.com

TruFulvic Provides Safe, True Energy

TruFulvic™ is a mitochondrial energy booster with spermatogenic, testosterone- enhancing, antioxidant and mineral bio-carrier properties, lending itself as a suitable ingredient for solid as well as liquid dosage formulations with its aqueous solubility and stability. It is derived from PrimaVie® Shilajit, a purified, standardized and consistent product from Natreon, backed by intellectual property (U.S. 7,250,181; U.S. 6,969,612; U.S. 6,440,436; U.S. 6,558,712; and EP 1 387 614), structurefunction claims, published and ongoing clinical studies, toxicity studies, human safety studies and extensive basic scientific research. TruFulvic is grandfathered as per the regulations of DSHEA (1994).

Chemistry 

TruFulvic is a fulvic acid complex with an assembly of naturally occurring low and medium molecular weight compounds comprising oxygenated dibenzo- a-pyrones (DBPs), both in reduced as well as in oxidized form, as the core nucleus, and acylated DBPs and lipids as part structure units. TruFulvic is a stable, water-soluble, multi-layer micellar structure that acts as a carrier for many classes of bioactive compounds, especially minerals. It is prepared by a novel process involving no solvents or microbes, thus eliminating the possibility of contamination by residual organic solvents or microbial toxins. Carbon, hydrogen and bitrogen analysis, and NMR spectroscopy have proven the authenticity of TruFulvic chemistry, compared to alluvial fulvic acids commonly available in the market.

Source of Essential Minerals 

TruFulvic contains more than 40 essential minerals and is rich in calcium, magnesium and potassium, low in aluminum and very low in heavy metals, with consistency from batch to batch. Super Antioxidant TruFulvic is a very strong antioxidant, better than many super fruits—ABTS and DPPH antioxidant assays have shown that the IC50 value of TruFulvic is 9. 5 and 43.6 ìg/ml respectively, compared to 3,990 and 2,000 ìg/ml for some alluvial fulvic acids. TruFulvic has an ORAC value of 2,373 ìmole TE/gm.

Spermatogenic Activity 

TruFulvic has shown spermatogenic activity in oligospermic patients. Twenty-eight patients who completed the treatment showed significant (P < 0. 001) improvement in spermia (+37.6 percent), total sperm count (+61.4 percent), motility (12.4–17.4 percent after different time intervals), normal sperm count (+18.9 percent) with concomitant decrease in pus and epithelial cell count compared with baseline value. Significant decrease of semen MDA content (18.7 percent) was observed. Moreover, serum testosterone (+23.5 percent; P < 0.001) and FSH (+9.4 percent; P < 0.05) levels significantly increased. HPLC chromatogram revealed inclusion of PS constituents in semen.1 

Energy Booster 

Treatment with TruFulvic for 15 days augmented energy synthesis during physical exercise (evaluated by “Harvard Step Test”) in human volunteers. This was established by increase in ATP and the established energy indices, e.g. AEC, TAN and ATP/ADP ratio in the whole blood indicating the efficacy of TruFulvic as an energy-booster.2 
Bioavailabiltiy Enhancer 

TruFulvic improved bioavailability of Coenzyme Q10 when administered in a hard gelatin capsule formulation providing bioavailability similar to soft gelatin capsules CoQSol® and Q-Gel.3 

Safety Profile 

Several toxicological, teratological, dermatological and genotoxicity studies of TruFulvic4-8 have shown that it has no toxicity. A 43-subject human study9 demonstrated safety of TruFulvic at a dose level of 250mg BID for 90 days. No significant change in the marker enzymes of liver and kidney function was observed.

References: 

1 T. K. Biswas, S. Pandit, S. Mondal, S. K. Biswas, U. Jana, T. Ghosh, P. C. Tripathi, P. K. Debnath, R. G. Auddy & B. Auddy. 2009. Andrologia, 42, 49-56.

2 Pilot Study on the Improvement of Human Performance with ReVitalET™ as Energy Booster (Note: RevitalET was the formerly used trademark of PrimaVie®/TruFulvic®), Project No.: NAT/CHEM-7/09/06.

3 Efficacy of TruFulvic™, prepared from Shilajit, in increasing the plasma energy/antioxidant status with reference to changes in CoQ10 levels in normal volunteers; Project No.: JBR/Res/02/2007, Natreon, India.

4 Kelginbaev, N.S., Sorokina, V.A., Stefandu, A.C. and Ismailova, V.N. 1973. Exp. Surg. Anesthes., 18, 31-35.

5 Anisimov, V.E. and Shakirzyanova, R. M. 1982. Kazan Med. J., 63, 65-68.

6 Acharya, S.B., Fortan, M.H., Goel, R. K., Tripathi, S.K. and Das, P.K. 1988. Ind. J. Exp. Biol., 26(10), 775-777.

7 Ghosal, S., Lal, J., Sing, S.K., Dasgupta, G., Bhaduri, J., Mukhopadhyay, M. and Bhattacharya, S.K. 1989. Phytother. Res., 3, 249-252.

8 Al-Hamaidi, A.R. and Umar, M. 2003. Online J. Biol. Sci., 3(8), 681- 684.

9 Clinical study for evaluation of safe use of purified and standardized Shilajit in normal volunteers; Project No.: JBR/Res/01/2009, J. B. Roy State Ayurvedic Medical College and Hospital, Kolkata, India.

NOW Foods/HealthCo
395 S. Glen Ellyn Rd.
Bloomingdale, IL 60108
Phone: (800) 477-3949
Fax: (630) 545-9080
e-Mail: info@healthco-intl.com • Website: www.healthco-intl

The Science of Enzyme-Treated Stevia 
By Michael Lelah, PhD, and Katrina Emmel, PhD

You have probably heard about Stevia. Stevia provides health benefits through its non-caloric value as a naturally derived sweetener. It differs from artificial sweeteners such as aspartame, in that it is not synthesized from chemicals, and it differs from natural sugars and sugar alcohols in that it has no caloric content.

Did you know that there are at least three different types of Stevia extracts available on the market? As a natural product, the Stevia that is used for sweetening beverages, foods and used in cooking is extracted from the Stevia rebaudiana Bertoni herb. The many glycoside and stevioside components in the leaves of Stevia provide the spectrum of sweetness (and bitterness) that it is known for. These components are extracted to make the commercially available products. The first type of extract is a natural product using water or ethanol to extract from the whole Stevia leaf, which is dried and sold as powder. The second type of extract is obtained by extraction, isolation and concentration of a specific stevioside— Rebaudioside A (Reb A). Both these types of extracts are sweet, but may require improvement to taste or masking of the bitter aftertaste with other sugars, sugar alcohols or flavors.

The third type of Stevia extract involves the treatment of the whole leaf extract with natural enzymes to enhance the flavor and reduce the bitter aftertaste through an enzymatic “glycosylation” process. This process adds sugartype molecules to the stevioside and glycoside components of the extract, which helps to reduce the bitter aftertaste and makes for a more palatable product. We have extensively investigated the chemistry of this extract and have published on the analytical chemistry details.1 During the enzyme treatment process, the naturally occurring glucose side chains of steviosides are extended, generally with between one and three additional glucose moieties. For example, Reb A naturally contains three glucose moieties attached to the basic steviol structure. We have determined that the enzyme treatment extends this to one (mono-glycosyl- rebudioside A), two (di-glycosly-rebaudioside A) or three (tri-glycosylrebaudioside A) components. The non-treated Stevia extract may contain about 35 percent Reb A, while the enzyme treated Stevia extract may contain 12 percent Reb A, 20 percent mono-glycosylated Reb A and five percent di-glycosylated Reb A. In this way the Stevia extract is “extended” by glycosylation through the enzyme treatment. What this means in practice is a better overall taste profile and a reduction in the bitter lingering aftertaste of Stevia extract.

We have also studied the hydrolysis of the enzymatic-treated Stevia in the body. Koyama et al.2 determined that non-enzymatic Stevia is hydrolyzed in the body eventually to Steviol. This occurs in the lower GI tract by the action of naturally occurring anaerobic bacteria in the lower GI. Steviol is not absorbed and is excreted in the urine. This is the basic mechanism as to why Stevia extract is noncaloric— the primary metabolite is excreted from the body. We have found that the mechanism for metabolism of enzyme-treated Stevia extract is similar to that for the non-enzyme treated extract. Similarly, the enzyme treated Stevia extract is hydrolyzed in the body to Steviol and is excreted in the same manner. Thus, the enzymatic treatment does not change the pathway for metabolism and therefore has similar properties in the body.

The science of the enzymatic treatment tells us that enzyme-treated Stevia extract, as found in NOW Foods’ product “Better Stevia®”, has been thoroughly researched, demonstrating that naturally enzyme-modified Stevia extract behaves similarly to Stevia extract, providing similar health benefits in terms of being a non-caloric sweetener, with the added advantage of an improvement in taste profile and a reduction in bitter aftertaste.

References: 

1 “High Performance Liquid Chromatography (HPLC) Characterization of the Enzymatic Glycosylation of Stevia rebaudiana: A Comparison of Enzyme Treated and Non-Enzyme Treated Stevia Extracts.” Waszkuc, T., Berkman, S., Emmel, K., Mohammed, F. Poster presented at the 38th Great Lakes Regional ACS Meeting (May 13-16, 2009), Lincolnshire, IL.

2 “High-Resolution TOF LC/MS Characterization of the Enzymatic Glycosylation of Stevia rebaudiana: A Comparison of Natural and Enzyme- Treated Stevia Extracts.” Emmel, K., Waszkuc, T., Kraemer-Berkman, S., Szczesniewski, A., D’Antonio, S. Poster presented at the 57th ASMS Conference on Mass Spectrometry and Allied Topics (May 31-June 4, 2009), Philadelphia, PA.

3 “High Performance Thin Layer Chromatography (HPTLC) Characterization of the Enzymatic Glycosylation of Stevia rebaudiana: A Comparison of Enzyme Treated and Non-Enzyme Treated Stevia Extracts.” Waszkuc, T., Berkman, S., Emmel, K., Jordan, S., Mohammed, F. Poster presented at the 2009 AOAC Int. Annual Meeting (September 13-16, 2009), Philadelphia, PA.

4 Koyama, E., Ohori, U., Kitazawa, K., Izawa, O., Kakegawa, K., Fujino, A., Ui, M. 2003. In vitro metabolism of the glycosidic sweeteners, Stevia mixture and enzymatically modified Stevia in human intestinal microflora. Food Chem. Toxicol. 41, 359-374.
NutraGenesis LLC 167 Main St., #208
Brattleboro, VT 05301
Phone: (802) 257-5345
Fax: (802) 251-6981
Website: www.nutragenesis.com

Sensoril Promotes Resistance to Stress and Enhances Mood 
By Dr. Bruce Abedon, director of scientific affairs

Stress has become an increasingly pervasive element in many people’s lives, negatively affecting their health and well-being by increasing anxiety and fatigue. Stress is caused by various forms of physical and emotional stressors that are difficult to avoid with today’s fast-paced lifestyles. These may include financial pressures, job stress and family demands. The body’s response to these stressors is known as the “fight or flight” response, which involves the hyypothalamus-pituitaryadrenal (HPA) axis.

When a person perceives a stressor, it initiates physiological changes in the hypothalamus region of the brain. The hypothalamus secretes corticotropinreleasing hormone (CRH), which migrates to the pituitary gland and stimulates the release of adrenocorticotropic hormone (ACTH). ACTH travels through the blood to the adrenal glands. The subsequent release of adrenaline and cortisol from these glands causes acute stress symptoms including rapid breathing, increased heart rate, anxiety/panic and other symptoms to prepare a person to confront or flee from the stressor.

Much of the stress in people’s lives is of a chronic or constant nature. This type of stress is most damaging to the body and mind. Under these conditions, many symptoms associated with acute stress diminish, being replaced by others such as anxiety, fatigue, memory problems, insomnia and difficulty concentrating that can manifest due to the continued presence of elevated serum cortisol levels. To improve their quality of life, consumers are increasingly seeking all natural solutions to stress management such as those provided by supplementation with proven stressreducing botanicals.

Sensoril is Clinically Proven to Reduce Stress 

Sensoril® is a clinically proven, multipatented, standardized extract of the revered ayurvedic, adaptogenic botanical, ashwagandha (Withania somnifera). Sensoril, which is marketed by NutraGenesis under exclusive license from Natreon, Inc., helps shield the body against the negative effects of stress via unique glycowithanolide bioactives that mimic the body’s own stress-reducing hormones. Adaptogens like ashwagandha are a small group of botanicals that increase the body’s ability to resist and recover from stress while stimulating an overall feeling of homeostasis. With its adaptogenic properties, Sensoril provides long-lasting relief from stress while improving mood, enhancing cognitive function, and reducing sleeplessness when taken daily.

In a double-blind, placebo-controlled human clinical trial that was 60 days in duration and involved 98 participants, subjects taking Sensoril experienced a statistically significant 69.9 percent reduction in an overall measure of stress-related symptoms (Figure 1). These subjects also experienced significant improvements in stress-related symptoms such as fatigue, inability to concentrate, memory issues and sleeplessness.

Sensoril Lowers Cortisol Levels to Help Enhance Mental Focus and Sleep 

Sensoril’s ability to reduce stress-related symptoms and improve mood stems from a novel mechanism of action that results in lower serum cortisol levels. Under conditions of chronic stress, cortisol levels can remain at high levels for long periods, which can lead to increased anxiety, weight gain, cognitive impairment, and trouble falling or staying asleep. In the same doubleblind, placebo-controlled human clinical trial, serum cortisol levels dropped significantly (by 24.2 percent) in subjects taking Sensoril (Figure 2). This reduction was accompanied by a significant rise in levels of DHEA, an energizing hormone that is associated with reduced fatigue. This trial also confirmed that supplementation with Sensoril improves markers of cardiovascular health, such as Creactive protein, lipid profile and blood sugar balance.

Sensoril Has a Comprehensive Safety Profile 

All natural Sensoril possesses an extensive safety record. It is well tolerated with no adverse effects reported in both human clinical and acute toxicity studies. Sensoril is GRAS-affirmed and can be used 365 days a year.

NutraGenesis is a leading provider of patented, all natural, clinically tested nutraceutical ingredients that enhance human health. NutraGenesis ingredients feature market-ready substantiated structure/function claims in a number of leading condition-specific areas including: stress, cognitive function, energy, weight management, cardiovascular health, blood sugar balance, immunity, anti-aging/beauty-from-within, inflammation response and antioxidant.

References: 

Auddy B, et al. JANA. 2008;11:50-56. 

Bhattacharya SK and A Muruganaodam. Pharmacol Biochem Behav. 2003;75:547-555.

Bhattacharya SK, et al. Indian J. Exp.Biol. 1997 ;35:236-239.

Bhattacharya SK, et al. Phytother Res.1987;1:32-37.

Choudhary M, et al. Chem Pharm Bull.2004;52:1358-1361.

Ghosal S, et al. Indian J Nat Prod.1988;4:12-13.

Ghosal S, et al. Phytother. Res. 1989:3:201-206.

Grandhi A, et al. J. Ethnopharmacol. 1994;44:131-135.

Karnick CR. Indian Med. 1991;3:1-5.

Kuppurajan K, et al. J Res Ayurveda and Siddha 1980;1:247-258.

Ray AB and N Gupta. Javascript:AL_get(this, ‘jour’, ‘Fortschr Chem Org Naturst.’); Fortschr Chem Org Naturst. 1994;63:1-106.


Nutratech, Inc.

10 Henderson Dr.
West Caldwell, NJ 07006
Phone: (973) 882-7773
Website: www.nutratechinc.com

The Safety of Advantra Z

Since Advantra Z®—the patented, all natural thermogenic ingredient for weight loss, fitness and energy—was introduced 15 years ago, research has consistently supported its safety and efficacy. Yet bitter orange, the source of Advantra Z, has been one of the media’s favorite “whipping boys,” with its safety frequently called into question.

Now Drs. Sidney Stohs and Harry Preuss—two of the country’s foremost researchers of performance enhancing ingredients—have put those questions to rest, publishing a definitive scientific analysis of the chemistry and safety of Advantra Z/bitter orange, drawn from 59 clinical research studies and reference sources: The Safety of Bitter Orange (Citrus aurantium) and pSynephrine, HerbalGram, Winter 2011.

Sidney J. Stohs, PhD, FACN, CNS, ATS, FASAHP, is Dean Emeritus, School of Pharmacy and Health Professions at Creighton University Health Sciences Center in Omaha, NE. Harry G. Preuss, MD, FACN, CNS, MACN, is Professor of Physiology, Medicine and Pathology at Georgetown University Medical Center in Washington, D.C. 

Their article concludes that, based on current research and the extensive ingestion of products containing bitter orange, Advantra Z/bitter orange is safe for human consumption and that challenges to the safety of this ingredient are without scientific basis. In the article, Stohs and Preuss explore six key topics.

The Chemistry of Bitter Orange 

The dominant amine in Advantra Z/bitter orange is p-synephrine, a stable synephrine isomer. PSynephrine primarily impacts beta3 receptors, which are found on every cell wall. Beta3 receptors are responsible for triggering thermogenesis and lipolysis— and they achieve this without affecting blood pressure.

Differences Between p- and m-Synephrine 

pSynephrine is often confused with msynephrine, which is found in nasal decongestants and sprays. MSynephrine impacts alpha, beta-1 and beta- 2 “excitory” receptors, increasing blood pressure and heart rate. MSynephrine does not appear to be inherent in bitter orange. Independent tests of the patented bitter orange extract, Advantra Z, showed it was not present at all (Sani-Pure Food Laboratories, 2010). Stohs and Preuss noted that potential negative side effects produced by msynephrine—which is not present in Advantra Z/bitter orange— couldn’t be attributed to psynephrine.

Differences Between Bitter Orange and Ephedrine?

Stohs and Preuss explain that the psynephrine found in Advantra Z/bitter orange is structurally similar to ephedrine, but pharmacologically different. These differences alter the ingredient’s lipid solubility, so it doesn’t cross the blood/brain barrier into the central nervous system. Consequently, Advantra Z and bitter orange exhibit little if any of ephedrine’s stimulant effects.

Safety/Toxicity Studies 

Stohs and Preuss point out that not one of the research studies published over the past eight years reported any serious or significant adverse events directly attributable to bitter orange. Nor did these studies demonstrate adverse cardiovascular or neurological events. This includes a recent study in human subjects given 50mg of psynephrine, which resulted in no heart rate or blood pressure effects relative to subjects given placebos. (Citrus aurantium Extract has No Effect on Blood Pressure or Heart Rate in Healthy Adults – Talbott, Experimental Biology, 2007) 

40-Year Safety Record 

Prescription and over-the-counter drugs are associated with 100,000 deaths each year (Centers for Disease Control). In contrast, there has been an annual average of only four adverse event reports (AERs) related to bitter orange since 1969—the year the FDA began monitoring AERs. Moreover, independent reviews of these reports could not establish bitter orange as the cause of the adverse events since there were many ingredients involved—plus health and lifestyle factors. (Review and Assessment of the Adverse Event Reports Citing Bitter Orange from 1969 to March 2004, American Herbal Products Association, September 2004; A Review and Assessment of the Adverse Event Reports Associated with Citrus Aurantium (Bitter Orange ) from April 2004 to October 2009, Stohs, August 2010).

GRAS Status?

Bitter orange has been considered a GRAS (generally recognized as safe) food ingredient by the FDA for decades. More than 100 million doses of products containing bitter orange have been consumed in the U.S.—as dietary supplements, fruits and juices— without any serious incidents shown to have been caused by bitter orange.

To review The Safety of Bitter Orange (Citrus aurantium) and pSynephrine, as well as other Advantra Z/bitter orange studies, visit www.nutratechinc.com/advz and click on Scientific Research.

Distributed worldwide exclusively by Nutratech, Inc., Advantra Z is the industry’s leading, allnatural thermogenic ingredient, patent protected for stimulating thermogenesis, reducing weight, increasing the percentage of lean muscle, improving athletic performance, and suppressing appetite.


OmniActive Health Techologies, Inc.

51 JFK Parkway, First Fl.W.
Short Hills, NJ 07078
Phone: (866) 588-3629
Fax: (877) 588-3629
e-Mail: usa@omniactives.com • Website: www.omniactives.com

Catotenoids in Focus: Lutemax 2020 Combines Lutein and Zeaxanthin for Sharper Results

Carotenoids are pigments that provide bright coloration (reds, oranges and yellows) and strong antioxidant action.1 While most carotenoids are found only in plants, lutein and zeaxanthin isomers are two carotenoids that naturally accumulate in the macula of the eye and are thought to protect against age-related degenerative diseases such as age-related macular degeneration, or AMD.1,2 Lutein and zeaxanthin supply the eyes with a yellow color known as the macular pigment.9,13 

Mechanism of Action 

The mechanisms by which lutein and zeaxanthin isomers are thought to provide protection to the eye are through their roles as blue light filters and as antioxidants. These macular pigments display antioxidant properties, including the ability to quench singlet oxygen and inhibit the peroxidation of membrane phospholipids. The macula is especially exposed to high light intensity and the high concentration of xanthophylls may exert a protective role against oxidative damage.

The Need to Reach Efficacious Levels 

As a natural component of the aging process, levels of lutein and zeaxanthin in the eye decrease with age, leaving the eyes susceptible to impairment.3 Epidemiological studies indicate that a dietary intake level of lutein and zeaxanthin at ~6mg/day would help counter this natural decline and have a positive effect on AMD prevention.3 However, current estimates of dietary intake of lutein and zeaxanthin in the US are around 1-3mg/day4,5,6, far below the level needed for optimum eye health. Given that AMD strikes an estimated 7. 1 percent of Americans aged 50-59, 14. 4 percent of those aged 70-79, and a startling 35.4 percent of Americans aged 80 and above, providing a means of supplementing dietary carotenoid intake is a pressing concern for modern eye health.14 

The Case for Combining Lutein and Zeaxanthin 

Many eye health ingredients supply carotenoids solely in the form of lutein, however, both lutein and zeaxanthin are vital to the health of the macula. A healthy human eye requires much higher concentrations of both.8,9 Zeaxanthin is isomeric with lutein. In the eye, lutein is present as a single stereoisomer, while zeaxanthin occurs primarily as a mixture of the 3R,3’R (i.e R. R Zeaxanthin) and 3R,3’S isomer (i.e R’S or meso-zeaxanthin). These three alltrans carotenoids are the major pigments in the retina.13 

Healthy diets typically have a 5:1 ratio of lutein to zeaxanthin.7 But traditional lutein ingredients contain only a 5:0.2 ratio. This is important to know because the two key zeaxanthin isomers are present in significantly higher levels in some parts of the eye. Lutein’s essential, but these zeaxanthin isomers have a stronger antioxidant power and an ability to absorb additional harmful radiation, which is crucial.1,15,16,17 

Lutemax 2020 Represents a Significant Eye Health Innovation 
To meet the need for an ingredient that delivers nutritionally relevant, enhanced levels of zeaxanthin isomers in addition to lutein, OmniActive introduced Lutemax 2020™ in late 2009. Lutemax 2020 delivers lutein and zeaxanthin isomers in significantly higher concentrations, for convenient and more beneficial nutrient availability for the eyes.

For a complete list of references, visit www.niemagazine.com.


Sabinsa Corporation

750 S. Innovation Cir.
Payson, UT 84651
Phone: (801) 465-8400
Fax: (801) 465-8600
Wesbsite: www.sabinsa.com

Terminalia arjuna Extract for Heart Health

Cardiovascular diseases continue to be the leading cause of morbidity and mortality globally, and dietary approaches to their management, need to address risk factors that are inherent in unhealthy diets and lifestyles.

In this context, an ancient remedy from the ayurvedic tradition, Terminalia arjuna, a tropical woody tree, has received renewed attention from scientists and medical researchers in recent times. Advocated for use in mixed formulations to support cardiovascular conditions, the use of the stem bark of “Arjuna” as a traditional medicine, can be traced back to the 7th century BC. Recent research has validated the beneficial role of Terminalia arjuna constituents in supporting normal lipid metabolism and antioxidant functions in the body.

Phytochemistry 

Scientists now attribute the beneficial effects of Terminalia arjuna to its active constituents including tannins, triterpenoid saponins (arjunic acid, arjunolic acid, arjungenin, arjunglycosides), flavonoids (arjunone, arjunolone, luteolin), gallic acid, ellagic acid, oligomeric proanthocyanidins (OPCs), phytosterols, calcium, magnesium, zinc and copper; concentrated in the stem bark (Figure 1).

Proposed Mechanisms of Action 

The ‘atherogenic lipid triad’ of high serum triglyceride levels, low serum high-density lipoprotein cholesterol (HDL-C) levels, and a preponderance of small, dense, low-density lipoprotein cholesterol (LDL-C) particles; and reduced activities of antioxidant enzymes are associated with the incidence of cardiovascular problems.

Pre-Clinical Observation 

Oral administration of Terminalia arjuna extract for 12 weeks resulted in the augmentation of serum levels of myocardial antioxidants, superoxide dismutase, catalase and glutathione, along with induction of heat shock protein, in animals. 1 Antihypertensive and cardioprotective effects were observed as well.2,3 

Interestingly, the cardioprotective effects were shown to be associated with the beneficial role of the phytonutrients in the stem bark in supporting the maintenance of normal blood lipid levels, and in increasing high-density lipoprotein levels.4 

In related research, ingestion of the stem bark extract was found to beneficially modulate lipolytic activity in the plasma, liver, heart and adipose tissues of hyperlipemic animals.5 The authors of this study hypothesized that the lipid lowering action was mediated through the enzyme systems involved in lipid metabolism. These effects are manifested in the inhibition of hepatic cholesterol biosynthesis, increased fecal bile acids excretion, enhanced plasma lecithin: cholesterol acyltransferase activity and the stimulation of receptor mediated catabolism of low density lipoprotein.

Clinical Validation 

The therapeutic role of Terminalia arjuna, long known in traditional medicine, has been validated in recent medical research. Early studies showed its beneficial role in subjects suffering from ischemic heart disease, with improvement in symptoms of angina pain and abnormal heart rhythm.6 

With reference to lifestyle factors, Terminalia arjuna was shown to benefit healthy smokers, who are at increased risk of developing cardiovascular diseases. Administration of Terminalia arjuna extract (500mg daily for two weeks) was found to significantly modulate endothelial functions in smokers.7 

A recent study evaluated the effects of Withania somnifera (ashwagandha) and Terminalia arjuna on physical performance and cardiorespiratory endurance in healthy young adults. Groups received 500mg of each plant extract, alone or in combination for 10 days. The researchers reported that both plant extracts appear to be safe for use in young adults under these conditions, and that Terminalia arjuna extract may improve cardiorespiratory endurance.8 
Terminalia arjuna extract is therefore an emerging phytonutritional approach to supporting normal cardiovascular functions, with a history of traditional use in single and mixed formulations. Additionally, isolated constituents such as Arjunolic acid are known to have anti-inflammatory properties with a potentially beneficial role in healthy aging in internal use as well as topical (cosmeceutical) applications.

References: 

1 Gauthaman K., et al. J. Ethnopharmacology, 2005 96 (3): 403-409.

2 Rose J, et al. Clin Nutr Insights 2000; 6:16.

3 Singh, G et.al J.Ethnopharmacology, 2008, 117(1):123-9.

4 Khanna, A.K, et al. Phytotherapy Res.1996; 10, 663-665 

5 Tiwari, A.K., et al. Int. J. Crude Drug Res. 1990; 1, 43-47 

6 Dwivedi, S et al. J Ethnopharmacol. 2007 114(2):114-29.

7 Bharani, A. et al. Indian Heart J. 2004; 56(2):123-8 

8 Sandhu JS, et al. Int J Ayurveda Res.2010; 1(3):144-9.


Soft Gel Technologies, Inc.

6982 Bandini Blvd.
Los Angeles, CA 90040
Phone: (800) 360-7484
Fax: (323) 726-7065
e-Mail: sales@soft-gel.com • Website: www.soft-gel.com

A Plant-Derived Anti-inflammatory Agent

Available exclusively from Soft Gel Technologies, Inc., Perluxan softgels contain a proprietary hops resin extract standardized to alpha acids—specific inhibitors of pro-inflammatory chemicals and derivatives—clinically demonstrated to reduce pain-causing compounds in a short time with a low dose. Not only does this unique botanical promote joint comfort quickly, it is also virtually free of phytoestrogenic and sleepinducing compounds.

Extensive in vitro, ex vivo and in vivo human clinical trials have been conducted over the last decade to establish the phytomedical credibility of Perluxan. Research has shown that Perluxan:

• Has a fast-acting effect, supporting joint health and soothing aches from overexertion of everyday activities within two hours of ingestion

• Moderately inhibits the pain-causing enzyme COX-2, thus managing minor pain without creating cardiovascular risk

• Only mildly inhibits the GI-protective enzyme COX-1, thus avoiding GI distress

• Significantly improves parameters of minor pain, with the ultimate outcome of increased function and better quality of life 

Perluxan Human Clinical Research 

Study #1: A dietary supplement is a selective COX-2 inhibitor both in vitro and ex vivo in healthy human volunteers.

A double-blind, randomized, parallel design trial was conducted on 19 healthy subjects. Subjects received a single dose of ibuprofen (400mg), a soft gel containing hops resin (450mg) or a capsule containing the hops resin converted to powder form (300mg 4x/day). Both supplement forms were standardized for hops alpha acids (150mg). Once again, levels of COX-1 and COX-2 were monitored at regular intervals over nine hours after the initial dose.

Study #1 Results 

The hops preparations were as effective as ibuprofen at inhibiting COX-2, but had significant COX-1 sparing activity over a nine-hour period. The hops resin soft gel was only administered once, whereas the hops powder capsules were administered in four divided doses over a nine-hour time period. The soft gel had a faster onset of action and gradually reduced pain-causing enzymes over the period of the study. This improved activity of the soft gel was probably the result of the natural state of the resin, solubilized in oil, as opposed to the conversion of resin-topowder for capsules and tablets.

Study #2: Efficacy of Oral Perluxan Intake in Subjects With Knee Osteoarthritis: A Randomized, Double- Blind Study 

A double-blind, placebo-controlled, randomized trial evaluated the effects of 14 days of Perluxan supplementation on 36 subjects with osteoarthritis of the knee. At baseline, they completed a Western Ontario McMasters Osteoarthritis Index (WOMAC) questionnaire to evaluate pain levels. The time to perform a 20-meter walk on a flat surface was also recorded.

Study participants were assigned to take Perluxan or a placebo. They were told to discontinue taking NSAIDs during the study period; however, up to 2,000mg of acetaminophen could be taken for pain relief, limited to two days weekly (rescue medication).

On day 15, the time to perform a 20-meter walk on a flat surface was again measured and improvements in pain relief were assessed using the WOMAC questionnaire.

Study #2 Results

• Perluxan intake showed a fast-acting effect on mean pain relief; significant improvement over placebo could be measured only two hours after the first ingestion.

• 1,000mg per day of Perluxan significantly improved parameters of osteoarthritis pain, including mean pain relief while in bed, sitting, lying and walking on a flat surface.

• The effectiveness of Perluxan was supported by the limited use of rescue medication in the treatment groups compared to placebo.

• The researchers concluded that Perluxan improved pain relief in patients with osteoarthritis, with the ultimate outcome of increased function and better quality of life.

Perluxan soft gels help support the body’s natural response to inflammation and provide a safe and effective option for worry-free joint support.

References: 

Lemay M, et al. Cyclooxygenase inhibiting activity of anti-inflammatory dietary supplements: Ex vivo evaluation. Nutrilite Health Institute, Access Business Group LLC, Buena Park, CA.

Lidbury, et al. The effects of AH88 on the activity of COX-1 and COX-2 using human whole blood and A549 cells. Pharmachem Laboratories, Kearny, NJ.

Lemay M, et al. A dietary supplement is a selective COX-2 inhibitor both in vitro and ex vivo in healthy human volunteers. Nutrilite Health Institute, Access Business Group LLC, Buena Park, CA.

Jager R, Purpura M. Efficacy of Oral Perluxan Intake in Subjects With Knee Osteoarthritis: A Randomized, Double-Blind Study. Pharmachem Laboratories, Kearny, NJ.

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