For more than a decade, Nutrition Industry Executive (NIE) has worked to cultivate relationships between ingredient suppliers and finished product manufacturers by providing Science of Supplements sections to highlight the research supporting ingredients that can help finished products stand out. In the interest of furthering that cause and providing greater insight into suppliers’ efforts, NIE offers its Human Clinical Studies section.

Human clinical trials provide the clearest support for an ingredient’s safety and efficacy.If a study is successful, it can yield significant returns on investment for a company.The payoff of a successful study can include health claims substantiation, use in scientific conference presentations and publication in peer-reviewed medical journals—all resulting in increased sales and distribution with manufacturers eager to incorporate proven ingredients in their formulas.

NIE has given companies a chance to provide detailed descriptions of the trials that have been conducted on their specific ingredients—study intention, design, results and conclusions—and highlight the applications for which these ingredients have proven safe and efficacious. NIE has also provided ample company information to foster immediate connections with parties interested in learning more.

Rice Protein Performance Similar to Whey in Sports Study

As the building material for muscles, protein is vital to athletes.In the past, sports nutrition literature has indicated that low doses of plant-based proteins do not increase muscle protein synthesis compared to animal-based proteins.1,2 While whey has long reigned as the go-to sports protein, greater awareness of environmental issues and a desire to resort to more “natural” ingredients have paved the way for more plant-based products rather than animal-based. Additionally, scares related to the meat and dairy industries with hormone contamination and chemical-infused manufacturing processes are some of the reasons consumers may be turning away from whey.

Until recently, nothing was known about rice protein’s ability as a sports nutrition supplement, though its novelty, hypoallergenic nature and prospective health benefits have made it a valuable candidate in today’s food ingredient market. For the first time, researchers at the University of Tampa investigated the effects of rice protein vs. whey protein paired with resistance exercise in a group of trained athletes. The objective of the study, published June 2013 in Nutrition Journal, was to determine if high doses of rice protein isolate could increase recovery and elicit adequate changes in body composition compared to equal amounts of whey protein isolate, if given following periodized resistance-training.3

Design 

Twenty-four healthy, college-aged males with a minimum of one year of strength training experience were recruited, and randomly and equally divided into two groups. Each group consumed isocaloric supplements containing either 48 g of rice protein isolate (Growing Naturals utilizing Oryzatein® created by David Janow and manufactured by Axiom Foods) or whey protein isolate (NutraBio) immediately following training. The training protocol was provided three times a week for eight weeks under direct supervision.Two weeks before and throughout the study, subjects were placed on a weight-maintenance diet by a registered dietician who specialized in sports nutrition.The diet consisted of 25 percent protein, 50 percent carbohydrates and 25 percent fat, and was closely monitored to ensure compliance. To measure acute recovery, participants gave ratings for perceived recovery, soreness and readiness to train before and after the first training session. Otherwise, participants were measured and recorded for muscle thickness, body composition, bench press and leg press strength at baseline (week 0), midway (week 4) and end (week 8).

Results 

Results showed there were no significant differences in the ratings between the groups supplemented with rice versus whey for recovery. In other words, both supplements produced a similar effect. Moreover, both groups experienced significant changes in body composition, strength and power from week 0 to week 8. Specifically, muscle mass, strength and power increased while body fat decreased and the changes observed were similar for both groups.Whey protein did not confer additional benefit over rice protein.

Despite rice protein’s suspected inferior quality, it was able to perform similarly to whey in this study. The authors assert that protein type or composition is of less significance when key nutrients are adequately provided. In this case, the one key nutrient was leucine. The leucine levels provided by the brown rice protein supplement appeared to be above the 2-3 g threshold needed to maximize muscle protein synthesis.4 

Conclusion 

Although more research is needed, these results indicate that at 48 g, rice protein can serve as a substitute for whey protein for building muscle and strength. This would be especially beneficial for those athletes who follow a vegan or other plant-based lifestyle, are unable to easily digest dairy proteins and/or are looking for an alternate protein source.

While the trend toward more natural products surges, Oryzatein appears to have utility over some dairy-based and soy-based proteins because it is not genetically modified (non-GMO), does not contain lactose or major food allergens, is manufactured without hexane, does not come from an animal known to be treated with growth hormones (rbST/bGH), anabolic steroids (AAS), estrogens and other hormones, antibiotics or other chemicals known to, suspected of, affecting or having an impact upon human health.

References: 

1 Wilkinson SB, Tarnopolsky MA, Macdonald MJ, et al. Consumption of fluid skim milk promotes greater muscle protein accretion after resistance exercise than does consumption of an isonitrogenous and isoenergetic soy-protein beverage. Am J Clin Nutr. 2007; 85: 1031-1040.

2 Norton LE, Layman DK, Bunpo P, et al. The leucine content of a complete meal directs peak activation but not duration of skeletal muscle protein synthesis and mammalian target of rapamycin signaling in rats. J Nutr.2009; 139: 1103-1109.

3 Joy J, Lowery RP, Wilson JM, et al. The effects of 8 weeks of whey or rice protein supplementation on body composition and exercise performance. Nutrition J. 2013; 12:86.

4 Norton LE, Layman DK. Leucine Regulates Translation Initiation of Protein Synthesis in Skeletal Muscle after Exercise. J Nutr. 2006; 136(2): 533S-537S.

Human Clinical Study Confirms kollaGen II-xs Efficacy for Joint & Connective Disorders

Certified Nutraceuticals, Inc. is pleased to announce the positive initial results of the ongoing human clinical studies for the efficacy of patented kollaGen II-xs™ – avian sternum collagen type II powder hydrolysate. This is the natural blend of mucopolysaccharide compounds and amino acids, which are the building blocks of joint cartilage. The process preserves all important nutrients and capable amino acids in order for kollaGen II-xs to be effective after enzyme digestion in the human digestive tract.

Positive Clinical Responses: 

For this study, 15 patients participated between the ages 17 and 81 years (eight males/seven females) with confirmed joint damage and cartilage injuries, diagnosed with imaging/scoping with low to high pain scales. The optimal dosage administered is 1,500 mg – 2,500 mg daily dietary supplement taken with citric juice on an empty stomach.

At the completion of the 30-day clinical trial with kollaGen II-xs, results confirmed:

• General pain (87.9 percent reduction; P = 0.007)

• Range of motion associated pain (76. 1 percent reduction; P = 0.021)

• Flexibility (62.4 percent increase; P = 0.005) 

The study also showed a normalizing of saliva pH levels, which is often indicative of a reduction in inflammation.

Conclusion 

The study results confirm that kollaGen II-xs, when taken at a dosage of 375 mg – 500 mg twice per day, appears to benefit joint inflammation, secondary mobility and other tertiary effects. KollaGen II-xs taken at a dosage of 1,500 mg – 2,500 mg daily significantly reduced pain and inflammatory response. This study demonstrated that kollaGen II-xs may be a viable treatment option for the management of joint and connective tissue disorders.

There were no adverse events reported during the study and the treatment was reported to be well-tolerated by study participants.

The ongoing human clinical trial is performed by Morton Scientific Group of Cambridge, ON, Canada, and overseen by qualified medical doctors.Certified Nutraceuticals supplies the world market with kollaGen II-xs in bulk powder, which is manufactured at its FDA-USDA-approved facility and proudly promotes the products as “Made in USA.” 

About kollaGen II-xs 

kollaGen II-xs utilizes an exclusive proprietary water extraction technology process to extract denatured avian sternum collagen type II powder without the use of solvent (ethanol) or harsh chemicals. This process preserves important nutrients and molecules to yield more hyaluronic acid (HA) and more chondroitin for optimum assimilation to help damaged cartilage. Additionally, natural enzymes are used to solubilize (hydrolysate) the product for maximum hydration and to control HA and chondroitin molecular weight (MW). Other hydrolyzed collagen products on the market are processed and produce very low MW collagen, which is not suitable for chicken sternum due to the contents of the delicate carbohydrates (HA and chondroitin), which needs to be at a higher MW. The low MW is suitable for bovine, porcine and fish collagen type I & III.

Certified Nutraceuticals’ CEO and the original inventor, Ahmad Alkayali, first introduced hydrolyzed chicken collagen type II in 1995. Since then, continued research and improvement has led to this new advanced collagen breakthrough. Alkayali was the first to introduce collagen supplements to the market more than a quarter of a century ago. Certified Nutraceuticals specializes in innovative quality collagen and anti-aging nutrients for longevity and good health.

KollaGen II-xs powder is 100 percent water soluble and can be made easily into capsules, tablets, beverages, functional foods and cosmetic applications.

For more information, visit www.certifiednutra. com, or contact its sales and marketing team, Infiniti Marketing Group, Inc., at [email protected] or(949) 455-9708 or www.infinitimg.com.

Study: Libifem Improves Sexual Desire in Women

Female hyposexual desire disorder, or female loss of libido, is widely prevalent, affecting one out of every four women. It is associated with severe effects, including depression, anxiety, stress, relationship difficulties, separation and divorce. A clinical study was conducted in Australia in 2012 under the auspices of the University of Queensland to test the efficacy of LibifemTM, or Trigonella foenum-graecum, fenugreek seed extract. Libifem is known for its aphrodisiac properties and is offered as an ingredient by Gencor. The study explored whether Libifem could safely and naturally restore a woman’s healthy libido, sexual vitality and desire.

Design 

Researchers selected 80 women aged 21 to 49 years to participate in the double-blind, randomized, placebocontrolled study. Participants were required to be healthy, with regular menstrual cycles and in stable monogomous relationships that they perceived to be secure and communicative. Those who were pregnant, depressed or taking prescription medications other than oral contraceptives were excluded. Sexual functioning was measured using the DISF-SR (female) QOL. Total score and domain scores were measured at baseline, four and eight weeks. Stress, fatigue and quality of the relationship were also measured. The study took place in Brisbane, Australia.

Results 

The total sexual functioning score increased significantly in those receiving Libifem compared to the control group at the one- and two-month data collection points. Sub-analysis showed significant increases in five domains, including sexual cognition, sexual arousal, sexual experience, orgasm and sexual drive/relationship at both one and two months in the group that received Libifem. No significant difference was detected in the placebo group. Hormone profiles, blood chemistry, cholesterol and liver function tests showed no difference between groups. The product was well-tolerated and no significant difference in metabolic or health parameters was observed. Reductions in perceived self-reported fatigue level were noted in the Libifem group.

Conclusions 

Researchers concluded that Libifem has a positive effect in enhancing libido in healthy, menstruating women in stable relationships. They noted positive changes for physiological aspects and psychosocial aspects of libido, as well as fatigue reduction.

In summary, Libifem offers a scientifically supported option for women who wish to increase their sexual desire. It is a natural product, and easy to use in product formulations.

Libifem is an extract of fenugreek, a traditional but relatively unknown remedy for sexual dysfunction, standardized to Fenuside™, Gencor’s trade name for a group of furostanol saponins. Fenugreek extracts have a long history of safe use.

About Gencor 

Gencor supplies value-added, sciencedriven ingredients that are designed to improve quality of life for consumers in a broad range of life stages. Rooted in ayurvedic tradition, Gencor specializes in herbal extracts manufactured under GMP compliance. Gencor markets specialized ingredients in more than 50 countries worldwide.

For more information, visit www.gencorpacific.com.

Reference: 

Steels E, Rao A, Vitetta L. Influence of Libifem, a Specialized Extract of Trigonella foenum-graecum (Fenugreek) on sexual function, hormones and metabolism in healthy menstruating women in a randomized, placebo-controlled study. Pending publication.

Proven Vitamin D Benefits From Mushrooms

Agrowing trend toward vegetarianism and veganism has arisen among Americans due to increasing consumer awareness of health, the environment and animal welfare. A 2013 Public Policy Polling survey found that six percent of Americans identify as vegetarian and seven percent as vegan.1 As the population of vegetarians, vegans and educated consumers grows, there is an increased demand for vegan-friendly food and nutritional supplement options that can work to provide adequate nourishment.

For vegan consumers, vitamin D can be especially hard to come by without the use of supplements or fortified foods, because it is mostly found in animal-based products. Mushrooms are gaining attention because studies have shown they are a naturally great source of vitamin D. This finding is significant because there have been few natural or reliable sources of vegan-friendly vitamin D. 

Monterey Mushrooms, Inc., the world’s largest supplier of fresh mushrooms, has developed a new post-harvest treatment in collaboration with the United States Department of Agriculture, and now enhances a large percentage of its fresh mushrooms with 400 IU of vitamin D. The demand for a natural source of vitamin D led Monterey to the development of High Vitamin D Mushroom Powder.

High Vitamin D Mushroom Powder is a natural, vegan, whole-food source of vitamin D2. It is an effective vitamin D2 ingredient, derived from certified organic Agaricus bisporus mushrooms (also known as white button, crimini, Portabella or champignon mushrooms).This product provides high levels of vitamin D2, containing 5,000 Ius/gram.

Recently, a study investigating High Vitamin D Mushroom Powder was published in the Journal of Dermato- Endocrinology, entitled, “Photobiology of Vitamin D in mushrooms and its bioavailability in humans.” This study examined the bioavailability of vitamin D2 in High Vitamin D Mushroom Powder compared with the bioavailability of commercially available vitamin D2 or vitamin D3 supplements, which are normally produced from animal extracts. Thirty healthy adults were enrolled in the study (six male, 19 female, mean age 35.2 years) and were randomized to ingest capsules containing 2,000 IU vitamin D2, 2,000 IU vitamin D3 or 2,000 IU mushroom vitamin D2 once a day for three months during the winter. The results demonstrated that ingestion of High Vitamin D Mushroom Powder was as effective at increasing and maintaining total serum 25(OH)D levels as supplemental vitamin D2 and vitamin D3.2 

In addition to High Vitamin D Mushroom Powder being a proven excellent source of D2, it also provides all of the nutritional benefits found in mushrooms. High Vitamin D Mushroom Powder contains nutrients including B vitamins, minerals, carbohydrates such as beta glucan and chitin glucan, fatty acids such as conjugated linoleic acid (CLA), and hard-to-find nutrients like Lergothioneine.

High Vitamin D Mushroom Powder has evidentiary support demonstrating that the low energy UVB light process used to convert ergosterol to vitamin D2 (ergocalciferol), thus allowing the mushrooms to create the vitamin D in the product, does not change the nutritional components or composition of the mushroom.

The study, entitled, “Vitamin D Mushrooms: Comparison of the Composition of Button Mushrooms (Agaricus bisporus) Treated Post Harvest with UVB Light or Sunlight,” compared the nutritional and compositional changes occurring in mushrooms exposed to sunlight with those occurring in mushrooms exposed to UVB light. Agaricus bisporus mushrooms from Monterey Mushrooms, Inc. were divided into control, sunlight and UVB light groups, and 5 kg of mushrooms were allotted per group. The results showed that other than the increase in vitamin D content, no other nutritionally or toxicologically significant changes in mushroom composition were identified in the UVB light group. Furthermore, the changes in vitamin D concentration occurring as a result of the UVB light were equivalent to those imparted by 2.5 h of sunlight exposure.3 

High Vitamin D Mushroom Powder is non-GMO, contains no carriers and is 100 percent organic certified mushroom powder. This vitamin D product also works to deliver well-balanced nutrition, is truly a dynamic whole food and an innovative, exciting new ingredient.

References: 

1 Jensen, Tom (26 February 2013). “Food issues polarizing America”. Public Policy Polling. Retrieved 28 February 2013.

2 Keegan, R. J. H., Lu, Z., Bogusz, J. M., & Holick, M. F. (2012). Photobiology of vitamin D in mushrooms and its bioavailability in humans. Dermato-Endocrinology. 4(4), 0-1.

3 Simon, R. R., Phillips, K. M., Horst, R. L., & Munro, I. C. (2011). Vitamin D mushrooms: comparison of the composition of button mushrooms (Agaricus bisporus) treated postharvest with UVB light or sunlight. Journal of Agricultural and Food Chemistry. 59(16), 8724-8732.

New Clinical Trial Confirms Viability of High-Dose Methylcobalamin Lozenges in Vitamin B12 Deficiency 

The prevalence of cobalamin deficiency among people over 65 years living in Western countries is estimated to be no less than five percent and could be as high as 20 percent.1 Normally, the body stores from 2,000 to 5,000 mcg of vitamin B12 (mostly in the liver), and it might take years to develop discernible symptoms.Diagnostically, serum levels of 200 pg/ml or less are regarded as deficient.However, a strong case has recently been made to view serum concentrations between 200 and 350 pg/ml as suboptimal for human health.2 

One of the reasons the elderly are predisposed to developing B12 deficiency is because absorption of cobalamin requires robust digestion in the stomach and intact production of intrinsic factor (IF). Gastric juices enable extraction of cobalamin from food, while IF binds with cobalamin for further absorption in the small intestine.Declining digestive function combined with limited consumption of red meat (the main dietary source of vitamin B12) may reduce the amount of cobalamin taken up by the body. Eventually, body reserves are depleted and symptoms of deficiency emerge. Understandably, strict vegetarians are also at a significantly higher risk of becoming cobalamin- depleted.

Non-specific symptoms of vitamin B12 deficiency may include fatigue, depression, memory loss, sensory peripheral neuropathic pain, etc. Thus, measuring cobalamin level in the blood becomes a critical diagnostic tool.Other signs that might be suggestive of deficiency among the older population include chronic gastritis, microcytic anemia and increased homocysteine level, especially when general malaise and depression are present.

Regardless of the mechanism, correction of cobalamin reserves is always indicated, and injections are thought to be preferred (to bypass the digestive tract). Typical protocol includes first weekly and then once-a-month 1,000 mcg vitamin B12 injections indicated for the rest of the patient’s life. As a result, many patients fall out of compliance once they start feeling better.

But even if the physiology of gastric secretion were intact, IF-enabled mechanism allows for absorption of only up to 3 mcg of vitamin B12 at a time.3 

Fortunately, a small percentage of B12 can also be absorbed by passive diffusion, which occurs throughout the entire GI tract, including the oral cavity, and without IF participation.3 Although only about one percent of cobalamin can enter the circulation via this mechanism, it becomes relevant when larger doses are administered. Because vitamin B12 has no known toxicity, very high doses can be given orally without safety concerns.Research shows that after oral administration of 10,000 mcg of cobalamin, about 100 mcg of vitamin B12 can be absorbed. A series of recent human bioavailability studies using 10,000 mcg methylcobalamin lozenges support this conclusion. (Unpublished, NOW Foods, Bloomingdale, IL; 2012).

The most recent confirmation of the effectiveness of high-dose methylcobalamin lozenges in treating vitamin B12 deficiency comes from the study conducted at ABC Wellness Clinic (Sterling Heights, MI) in collaboration with NOW Foods. The findings were presented at the 2012 Conference by the American Association of Naturopathic Physicians.4 In this clinical trial, 10 patients with newly diagnosed cobalamin deficiency were randomly assigned to receive either once-a-week B12 injections (1,000 mcg) or daily high-dose 10,000 mcg methylcobalamin lozenge for eight weeks. The study demonstrated that the lozenges were in fact as effective as the injectable regimen. Both treatments resulted in complete normalization of serum cobalamin levels in all patients (Figure 1). Additionally, homocysteine levels returned to normal and general symptoms improved regardless of the type of the treatment. The results demonstrate that a high-dose daily methylcobalamin lozenge regimen is a viable and convenient option to vitamin B12 injections, and should be considered in practice as equally effective.

Additionally, lozenge supplementation offers a significant cost advantage as compared to injections. In this study, the supplementation was approximately $35 for eight weeks. The cost of just one office visit and a single injection was estimated to be $100, adding up to $800 for the duration of the study. This makes high-dose methylcobalamin lozenges a regimen that is more economical and has potentially better patient compliance.

References: 

1 Clarke R, Grimley Evans J, Schneede J, et al. Vitamin B12 and folate deficiency in later life. Age and ageing.Jan 2004;33(1):34-41.

2 Spence JD, Stampfer MJ. Understanding the complexity of homocysteine lowering with vitamins: the potential role of subgroup analyses. JAMA. Dec 21 2011;306(23):2610-2611.

3 Andres E, Dali-Youcef N, Vogel T, Serraj K, Zimmer J. Oral cobalamin (vitamin B12) treatment. An update. Int J Lab Hematol. Feb 2008;31(1):1-8.

4 Culik DA BL, Sharpee RL, Pacholok SM. Effect of Daily High-Dose Methylcobalamin Lozenge Regimen or Weekly Injections in Patients with Cobalamin Deficiency. A Single Center Prospective Randomized Open-Label Trial. AANP 2012 Conference: ABC Wellness;2012.

UC-II Offers Joint-Health Efficacy at 40 mg a Day

UC-II® is a patented undenatured type II collagen for joint health support. UC-II has undergone rigorous third-party research and testing for efficacy, safety and quality. The research path began when researchers, including those at Harvard University Medical Center, found the benefits of undenatured type II collagen for joint health and published research in peerreviewed journals. InterHealth has continued to systematically build the research portfolio for UC-II. Its latest research study was conducted on 55 healthy, active adults.

Healthy Subject Research 

The efficacy of UC-II in supporting joint function in healthy subjects was studied in a randomized, double-blind, placebo-controlled study of 55 people.Subjects took 40 mg of UC-II or placebo for 120 days. The physical stressor was induced by placing subjects on a standardized stepmill procedure until they complained of knee discomfort of at least 5 on an 11-point Likert scale.While on the stepmill, the “time to onset of discomfort” was measured.When subjects got off the stepmill the “time to offset of discomfort” was measured. Goniometry was used to assess the knee range of motion.1

• The average knee extension at day 120 was significantly greater for people taking UC-II compared to placebo. The UC-II group demonstrated a statistically significant increase in average knee extension at day 90 and day 120 compared to baseline.

• The minimum time to onset of joint discomfort compared to baseline was significantly greater in the UC-II group at day 90 and day 120, while no significant changes were observed in the placebo group.

• The percent change in maximum time to offset of discomfort in the UC-II group showed greater statistically significant reductions compared to baseline of up to 31.9 percent at day 60; 51.1 percent at day 90; and 51.9 percent at day 120. Comparisons between groups did not reach statistical significance.

Comparative Study of UC-II & Glucosamine + Chondroitin 

A randomized, double-blind, clinical study was conducted in North America on 52 people with osteoarthritis of the knee. Subjects took 40 mg of UC-II or 1,500 mg of glucosamine + 1,200 mg of chondroitin for 90 days. UC-II significantly decreased joint pain, discomfort and immobility compared to baseline using three different assessment tools: WOMAC, VAS and Lequesne functional index.2

• UC-II reduced WOMAC score by 33 percent. Glucosamine + chondroitin reduced WOMAC score by 14 percent.

• UC-II reduced VAS score by 40 percent. Glucosamine + chondroitin reduced VAS score by 15 percent.

• UC-II reduced Lequesne score by 20 percent. Glucosamine + chondroitin reduced Lequesne by six percent.

Pilot Study for Proof of Principle 

In a human pilot study, five women with osteoarthritis took 40 mg of UC-II a day for 42 days. UC-II significantly reduced pain, morning stiffness and stiffness following periods of rest. Average reduction in pain was 26 percent.3 

Safety 

UC-II is an FDA-notified, published new dietary ingredient (NDI), and is a nonnovel food in the E.U. It is sourced and manufactured in the U.S. in a GMP-certified facility. A comprehensive safety profile on UC-II has been established demonstrating a wide margin of safety for human consumption based on an array of toxicological studies. UC-II has been determined GRAS by one of the nation’s leading toxicology groups. UCII is also non-GMO tested.

Summary 

UC-II is supported by two clinical studies, both conducted in North America.With increased FDA regulatory scrutiny over dietary supplement structure/function claims, it becomes more important to have healthy subject research to substantiate these types of claims. UC-II healthy subject research may help substantiate reduction in exercise-induced joint pain claims as well as provide strong substantiation for healthy joint flexibility, mobility and comfort claims.UC-II has also been extensively studied in dogs and horses for animal health and nutrition. Additionally, UC-II’s 40 mg dosing works well in any formulation and will not increase pill size in combination products.

References: 

1 Udani JK. UC-II for joint health: a randomized, double- blind, placebo-controlled adaptive design, pilot study [study abstract]. JACM. 2013;19:A4.

2 Crowley DC, Lau FC, Sharma P, et al. Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: a clinical trial. Int J Med Sci. 2009; 6:312-321.

3 Bagchi D, Misner B, Bagchi M, et al. Effects of orally administered undenatured type II collagen against arthritic inflammatory diseases: a mechanistic exploration. Int J Clin Pharm Res. 2002;22:101-110.

LACIDOFIL: The Probiotic Blend Backed By 20+ Clinical Studies

Lallemand Health Solutions has just announced that its key probiotic blend LACIDOFIL® (L. Rhamnosus R0011 and L. helveticus R0052) has been elected for a large-scale paediatric clinical study in around 900 children with gastroenteritis across Canada. Following a pilot study, the new multicenter, randomized, placebo-controlled study has been instigated by Dr. Stephen Freedman of the University of Calgary and Alberta Children’s Hospital Research Institute. The aim is to evaluate the efficacy of LACIDOFIL in the treatment of acute gastroenteritis in patients admitted to children’s hospital.

The choice of LACIDOFIL for this study has been motivated by a solid clinical substantiation: the probiotic formula is supported by 22 clinical studies, but also many in-vivo and in-vitro studies on the behavior and modes of action of the probiotic in the gut. In December 2011, scientists from University of Florida have published a comprehensive review of these studies.1 

LACIDOFIL is a specific probiotic blend that was developed approximately 20 years ago by Lallemand to support and maintain the digestive microflora, and both the finished product formulation and the individual strains have been extensively researched over the years.Altogether, mechanistic and animal data suggest that the LACIDOFIL strains individually, as well as the finished product, have the ability to directly influence pathogen-host interaction, modulate the immune pathways, primarily by downregulating pro-inflammatory responses, and to help maintain the protective gut barrier. These properties are illustrated by the probiotic benefits shown in the numerous clinical studies, encompassing different health segments, in and beyond gut health. Here is a quick overview of these applications2:

• Prevention of antibiotic-associated and acute diarrheas: LACIDOFIL is particularly effective in preventing and reducing the development of digestive pathogens such as C. difficile and preventing AAD (antibiotic-associated diarrhea) in both children and adults (see Figure 1). A recent Indonesian study indicates that LACIDOFIL is also beneficial in the management of acute diarrhea in adults.3

• Pediatric gastrointestinal (GI) disorders: due to the high incidence of diarrhea and intestinal infections in infants and children, many researchers have investigated the use of LACIDOFIL in the paediatric population. They showed that LACIDOFIL induced a faster recovery in children with GI diseases and diarrhea. Moreover, some investigators have shown positive effects of LACIDOFIL on the immune status of children with acute intestinal infection. Professor Freeman’s on-going clinical study is expected to bring further evidence for this indication.

• Lactose intolerance: the probiotic blend has been shown to improve symptoms of lactose maldigestion in patients.

• H. Pylori eradication: when added to conventional therapy in H. pylori infected patients, LACIDOFIL both improved symptoms of the conventional therapy, and increased eradication of H. Pylori.

• Irritable bowel syndrome (IBS) management: two studies have shown positive effects of LACIDOFIL on IBS symptoms in patients (stool frequency and consistency, bloating, abdominal pain, etc.).

• Atopic dermatitis (AD): beyond digestive health, this skin disorder represents another potential area of application for LACIDOFIL blend. Clinical trials have been carried out so far in AD patients (children) and showed a significant improvement of clinical symptoms, associated with an improved quality of life for patients and their families. The probiotic also demonstrated positive effects on immune responses and milk tolerance in patients.

• Vaginal dysbacteriosis: lactobacilli have also been shown to help stabilise the vaginal microflora. Two trials investigating the impact of LACIDOFIL supplementation on vaginal dysbacteriosis have been carried out in women who underwent caesarean section delivery.LACIDOFIL helped prevent vaginal dysbacteriosis in both studies.Moreover, it also prevented the development of AAD.

Finally, this wealth of clinical evidence has gained the formula several positive health claims in Canada: “Probiotic to benefit health and/or confer a health benefit”, “Restoring and maintaining intestinal flora” and “Helps to reduce the risk of antibiotic associated diarrhea (in children and adolescents from 2 to 18 years of age)” (Claim NPN 80020017).

LACIDOFIL is available either as an ingredient to formulate custom food supplements or as a finished product under various galenic forms: capsules, sachets, sticks or liquid drops, which have recently been developed and are well-suited for children.

References: 

1 Foster, L.M. et al., Beneficial Microbes. 2(4): 319-334 (2011).

2 Maydannik, V., et al., Pediatrics, Obstetrics and Gynecology. 3: 53-57 (2010).

3 Simadibrata M., et al., Journal of Clinical Medicine and Research. Vol. 5 (2), pp. 23-28 (2013)

Capros: Product of Choice to Help Improve Cardiovascular Health

Capros® is an aqueous extract derived from edible fruits of Phyllanthus emblica (Indian gooseberry), containing emblicanin-A, emblicanin-B, punigluconin and pedunculagin as bioactives, and is a super antioxidant with a combined ORAC value (superoxide anion, hydroxyl, peroxynitrite, peroxyl and singlet oxygen) of 47,000 µmoles TE/g. A recently published randomized, double- blind, placebo-controlled clinical study1 has shown Capros to have excellent properties to support cardiovascular health by improving endothelial function and endothelial biomarkers; reducing total, LDL and VLDL cholesterols, triglycerides and hsCRP; increasing HDL and decreasing glycosylated hemoglobin.

In the clinical study, Capros was examined at 250 mg BID and 500 mg BID dosages with Atorvastatin 10mg OD and placebo as controls for 12 weeks with 80 type 2-diabetic subjects who have been on treatment with Metformin.Endothelial function, nitric oxide (NO), glutathione, MDA, total cholesterol, HDL, LDL, triglycerides, hsCRP and HbA1c were measured at the beginning and end of 12 weeks. Capros showed dose-dependent significant improvement in all the parameters and, at 500 mg BID dosing, it is comparable to Atorvastatin 10 mg OD in many of the parameters, although Atorvastatin performed better in decreasing NO, total cholesterol and triglycerides.

Additional Clinical Studies Pending Publication 

The following randomized, doubleblind, placebo-controlled studies were completed and submitted for publication in PubMed listed peer-reviewed journals, and also support the cardiovascular benefits of Capros.

• A 30-subject, 60-day study in smokers with 250 mg BID dosage has shown that Capros

• A 40-subject, 12-week study with 500 mg BID dosage in type 2-diabetic subjects stabilized on Glimiperide treatment

• A 59-subject, 12-week study with 250 mg BID and 500 mg BID dosages in healthy volunteers with pre-metabolic syndrome symptoms

• A platelet-aggregation study in 10 healthy volunteers in each group receiving

(a) single 500 mg dose of Capros, (b) single 500 mg dose of Capros + single 75 mg dose of Clopidrogel, (c) 500 mg of Capros for 10 days + single 75mg dose of Clopidrogel, and (d) 500 mg of Capros for 10 days + single 75mg dose of Ecospirin

• A 12 healthy volunteer, 14-day, cross-over, cold pressor-induced cardiovascular changes study with 500 mg BID dosing

• A 10 healthy volunteer, 14-day, cross-over, mental stress-induced cardiovascular changes study with 500 mg BID Capros 

Structure-Function Claims

• Protects against oxidative stress by serving as a broad-spectrum natural antioxidant.

• Is a cascading antioxidant prolonging the free radical-scavenging effects.

• Is a superior antioxidant that does not produce pro-oxidant effects.

• Helps to maintain the integrity of cellular DNA by protecting it against damage from oxidative stress.

• Supports healthy skin during sun exposure, protecting cells from the potentially harmful effects of oxidative stress produced by UV-light.

• Inhibits the activity of collagenase thus protecting the skin’s collagen, an important factor in maintaining healthy skin and protecting skin from premature aging.

• Is an effective detoxifier and rejuvenator.

• Supports cardiovascular health.

Capros is a product of choice for cardiovascular support, energy and diabetic support formulations. Unlike omega-3 fatty acids and CoQ10, Capros is watersoluble and stable, and thus is an ideal product to be formulated into beverages, though it can also be formulated into solid dosage forms.

* 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.

References: 

1 P.Usharani, N.Fatima and N. Muralidhar. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy. 2013:6 1-10.

Dr. Richard Bloomer’s Clinical Study Findings on Capsimax

By Dr. Jayant Desphande, Chief Technology Officer

In response to the growing prevalence of obesity and overweight, Dr. Richard Bloomer and fellow scientists at the Cardiorespiratory and Metabolic Laboratory of the Department of Health and Sport Sciences at the University of Memphis researched the effect of oral intake of capsaicinoids on body fat and weight loss parameters. Bloomer et. Al., conducted a randomized, placebo-controlled, double-blind, cross-over study involving 20 young, healthy, exercisetrained men and women to explore the effects of Capsimax® on lipolysis and catecholamine secretion. Lipolysis is the breakdown of lipids (or fats) through hydrolysis to produce free fatty acids (FFA), which can then be utilized by the body for energy.Catecholamines include hormones such as epinephrine and norepinephrine, which serve as targets for most stimulant drugs. These hormones prepare the body for physical activity, but in turn put the body in an unnecessary state of “stress.” They are of particular interest due to the rise in safety issues surrounding the impact many weight loss supplements and commercial drugs have had on catecholamine levels.

In this study, subjects rested for 48 hours prior to and received a standardized diet 24 hours prior to Test Day 1.On Test Day 1, subjects were randomized to receive either a placebo or 100 mg of Capsimax (providing 2 mg capsaicinoids) following a 30-minute rest period at which time heart rate (HR) and blood pressure (BP) were observed and blood samples were drawn. The subjects followed blood sampling with ingestion of treatment and a two-hour rest period. Following the two-hour rest period, HR and BP were again observed and a second blood sample was drawn.Subjects were subsequently exercised on a treadmill for 30 minutes at 65 percent of maximal heart rate reserve. A third blood sample was drawn within one minute of cessation of exercise and a fourth 90 minutes following cessation of exercise. In addition to their observation when blood was drawn, HR and BP were also observed at one and three hours post treatment intake. Exactly one week later, subjects underwent the same protocol, receiving the alternate treatment.

What Bloomer and his team found was that ingestion of low dose (2 mg) Capsimax was associated with an increase in blood FFA and glycerol at selected times post ingestion, as compared to placebo with no difference noted in HR, systolic BP or diastolic BP between placebo and Capsimax. In terms of percent change from preexercise, FFAs were higher in the Capsimax treatment group as compared to the placebo group at two hours (p = 0.025) and at 2.5 hours (p = 0. 015), and glycerol was higher in the Capsimax treatment group as compared to the placebo group at four hours (p = 0.011). Additionally, no differing effect on epinephrine or norepinephrine in response to supplementation or placebo was observed. It is also important to note that the study concluded without any adverse events reported. These data suggest that Capsimax may safely mobilize fat metabolism and improve body composition to aid weight management.

Reference: 

Bloomer RJ, Canale RE, Shastri S, Suvarnapathki S. Effect of oral intake of capsaicinoid beadlets on catecholamine secretion and blood markers of lipolysis in healthy adults: a randomized, placebo controlled, doubleblind, cross-over study. Lipids Health Dis. 2010 Jul 15;9:72. Doi: 10.1186/1476-511X-9-72.

The Calming & Cognitive Benefits of Zembrin

By Barbara A. Davis, PhD, RD, Director of Medical & Scientific Affairs

Consumer concern over cognitive health, including lack of mental sharpness/focus and stress, is significant. In fact, according to data from the HealthFocus® International 2012U. S. Trend Survey, almost half (46 percent) express a high degree of concern over both issues. This same report also reveals that many look to dietary supplements in support of mental focus (41 percent) and stress management (33 percent). However, to date, few clinically supported ingredients have been available to meet these needs.

Zembrin® is a standardized, characterized and patented botanical extract from the Sceletium tortuosum herb. It is a sustainable and socially responsible product, based on more than 300 years of documented indigenous use and has been developed for modern use in conjunction with recognized representatives of the indigenous knowledge- holders, the South African San Council.

This unique botanical extract is experiential—users can actually “feel” its benefits. It has a patented dual mechanism of action involving phosphodiesterase- 4 (PDE4) and serotonin (5-HT) re-uptake inhibition.1 

The safety and efficacy of Zembrin has been documented in three clinical trials. The first study, designed to evaluate safety and tolerability, was a randomized, double-blind, placebo-controlled trial conducted in 30 healthy individuals for three months. Zembrin was confirmed to be safe and well tolerated at 8 and 25 mg per day. Intriguing positive effects on stress, mood, coping and quality of sleep were spontaneously self-reported in subject diaries of the two Zembrin groups but not in the placebo group.2 

A second clinical trial was designed to evaluate the effect of daily Zembrin administration on cognition using a double blind, placebo-controlled, crossover design in healthy adults.3 In this study, 21 subjects were administered 25 mg capsules of either Zembrin or placebo once daily for three weeks. After a three-week washout period, they were switched to the respective placebo or Zembrin arm for an additional three weeks. Cognitive function was evaluated by the validated CNS VitalSign® inventory.

Statistically significant improvements in executive function (p<0.022) and in cognitive set flexibility (p<0.032) were observed with 25 mg Zembrin daily compared to placebo in this cohort of healthy, cognitively intact subjects.

A third clinical trial has recently been completed.4 This groundbreaking functional- magnetic resonance imaging (fMRI) study examined anxiety-related activity in the amygdala and its connectivity within the threat circuit of the brain. In a double-blind, placebo-controlled, cross-over design, 16 healthy participants were scanned during performance of perceptual load and emotion- matching tasks two hours after ingesting a single 25 mg capsule of Zembrin or placebo. Results from this study showed that a single dose of Zembrin acts on areas of the brain that recognize and respond to threat, confirming the calming effect of this botanical extract.

These initial studies provide clinical evidence for the dual action of Zembrin in cognitive function enhancement and calming activity. This unique “alert-serenity” signature is useful for dealing with the stresses of everyday life. Stress is documented to negatively impact cognitive function5, suggesting the calming effects of Zembrin may contribute to the observed cognitive benefits. Encouraged by these positive results, an ongoing clinical research program is being planned for Zembrin.

Zembrin is self-affirmed GRAS and can be delivered in supplements, with a single daily dosage of only 25 mg, or in foods and beverages with dosages up to 12.5 mg per serving. 

References: 

1 Harvey AL, Young LC, Viljoen AM, Gericke NP (2011). Pharmacological actions of the South African medicinal and functional food plant Sceletium tortuosum and its principal alkaloids. J Ethnopharmacol. 137: 1124–1129.

2 Nell H., Siebert M., Chellan P., and Gericke N. (2012) A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Extract Sceletium tortuosum (Zembrin) in Healthy Adults. The Journal of Alternative and Complementary Medicine. 18:1-7.

3 Chiu S, Farmina-Woodbury M, Cernovsky Z, Bureau Y, Hou J, Raheb, H, Terpstra K, Badmeav, V & Gericke N. The effect of extract Sceletium tortuosum (Zembrin), targeting Phosphodiesterase subtype-4 ( PDE-4), on cognitive function: a proof-of-concept randomized doubleblind, single site, placebo-controlled cross-over study in healthy adults. (Manuscript submitted).

4 Terburg D, Syal S, Rosenberger LA, Heany S, Phillips N, Gericke N, Stein DJ & van Honk J. Acute effects of (Zembrin), a dual 5-HT reuptake and PDE4 inhibitor, in the human amygdala and its connection to the hypothalamus. Neuropsychopharmacology. 21 August 2013; doi:10.1038/npp.2013.183. 

5 Shanksy RM & Lipps J. Stress-induced cognitive dysfunction: hormone-neurotransmitter interactions in the prefrontal cortex. Frontiers in Human Neuroscience.05 April 2013; doi: 10.3389/fnhum.2013.00123.

Study: Almega PL’s EPA Absorption, Bioavailability Better than Krill

Astudy recently published in the journal Lipids in Health and Disease showed that on a gram-by-gram basis the algal oil in Almega PL™ offers better omega-3 bioavailability than krill oil.1 

Almega PL, manufactured by Qualitas Health, is a vegetarian, EPArich, polar lipid-structured omega-3 oil. Sourced from a researched strain of microalgae selected for its high level of EPA omega-3 and unique polar-lipid structure, Almega PL contains omega-3 fatty acids conjugated with phospholipids and glycolipids that provide superior absorption and digestibility.

Study Background 

The long-chain n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have human health benefits. For environmental sustainability, alternatives to fish and krill as sources of EPA and DHA are needed. Oil from the micro-algae Nannochloropsis oculata contains a significant amount of EPA conjugated to phospholipids and glycolipids and no DHA. Krill oil contains EPA and DHA conjugated to phospholipids. The study compared the appearance of fatty acids in blood plasma of healthy humans after consuming a high fat meal accompanied by either algal oil or krill oil.

Methods 

Ten healthy males aged 18 to 45 years consumed a standard high fat (55 g) breakfast followed by either algal oil (providing 1.5 g EPA and no DHA) or krill oil (providing 1.02 g EPA and 0.54 g DHA). All participants consumed both oils in random order and separated by a seven-day washout period. Blood samples were collected before the breakfast (baseline) and at several time points up to 10 hours after taking the oils. Fatty acid concentrations (g/ml) in plasma were determined by gas chromatography.

Results 

Fatty acids derived mainly from the breakfast appeared rapidly in the plasma, peaking about three hours after consuming the breakfast, and in a pattern that reflected their content in the breakfast. There were time-dependent increases in the concentrations of both EPA and DHA with both algal oil (P<0.001 for EPA; P=0.027 for DHA) and krill oil (P<0.001 for both EPA and DHA).

The concentration of EPA was higher with algal oil than with krill oil at several time points. The maximum concentration of EPA was higher with algal oil (P=0.010) and both the area under the concentration curve (AUC) and the incremental AUC for EPA were greater with algal oil (P=0.020 and 0.006). There was no difference between oils in the AUC or the incremental AUC for DHA.

Conclusion 

Study researchers concluded that the algal oil in Almega PL results in greater concentration of EPA in plasma than krill oil, even taking into account the different EPA contents of the two oils. This difference, the researchers suggested, may relate to the different chemical constituents of the two oils, namely the presence of glycolipids. The results showed that the polar-lipid -rich algal oil in Almega PL is a good source of EPA in humans, offering superior absorption and bioavailability of EPA compared to krill oil.

About Qualitas Health 

Qualitas Health develops high-value vegetarian food supplements and pharmaceutical ingredients based on microalgae. With deep experience and expertise in algae cultivation and extraction gained from the biofuels sector, Qualitas has developed a unique and proprietary technology for strain selection, sustainable algae farming, harvesting and oil processing. This allows for the effective production of premium omega-3 algae oil for a wide range of applications.

Reference: 

1 Kagan ML, West AL, Zante C, et al. Acute appearance of fatty acids in human plasma – a comparative study between polar-lipid rich oil from the microalgae Nannochloropsis oculata and krill oil in health young males. Lipids Health Dis. 2013 Jul 15;12:102. Doi:10. 1186/1476-511X-12-102.

Review of Curcumin Studies

In recent times, researchers and consumers have both shown substantial interest in naturally derived health supplements for both preventive care and management of various health conditions.Today, when inflammation is recognized as the root cause of several chronic disease affecting millions of people across all ages and races, focus has shifted to Curcuminoids, outstanding anti-inflammatory and antioxidant agents, which have a long history of use in Indian traditional medicinal system— ayurveda. Curcuminoids are obtained from rhizomes of turmeric and occur as a mixture of three compounds: curcumin (dominant), demethoxy curcumin and bisdemethoxy curcumin. Sabinsa secured a patent on an optimized composition containing all the three curcuminoids described in U.S. patent 5861,415 for its brand Curcumin C3 Complex®. In last 15 years, Curcumin C3 Complex has been part of more than 60 research studies published in peer-reviewed journals, with several of them in clinical settings. Growing scientific evidences have shown benefits of C3 Complex in several chronic inflammatory conditions such as arthritis, asthma, liver dysfunction, diabetes, obesity, oral lichen planus, Alzheimer’s disease and many more.

Recently a group of researchers published the effect of C3 Complex on the lipid profile in obese subjects in the peer-reviewed journal Phytotherapy Research showing the potential of Curcumin in improving the lipid profile in obese subjects.1 

The study provides evidence regarding the benefits of C3 Complex in the management of obesity related health conditions. Today, obesity is one of the major health concerns in not only developed countries but also in developing countries largely attributed to changing dietary habits. For example, 30 percent of the population in Mexico is considered to be obese. Obesity is also recognized as a primary risk factor for several diseases such as diabetes, hyperlipidemia, cardiovascular disease and joint problems.

The study was carried out as randomized, double-blind, cross-over study on 30 obese subjects aged between 18 and 65 years for a four-week period. The subjects recruited for the study had BMI= 30, LDL cholesterol ranging between 130 and 190 mg/dl and with no history of taking any lipid lowering drugs. The subjects were randomized to either one of the two treatment regimens receiving curcuminoids or placebo for 30 days before crossing over to receive alternate regimen.

The subjects in treatment group were provided with 500 mg of capsules Curcumin C3 Complex containing BioPerine® (patented extract from black pepper fruits), with 1 g dosage of curcuminoids to be taken every day.BioPerine has been clinically found to enhance the bioavailability of curcuminoids in earlier studies.

The results of the study showed C3 Complex supplementation (1 g/day) in obese subjects was associated with significant lowering of triglyceride levels.This lowering of triglyceride levels in obese subjects can reduce the chances diseases such as cardiovascular disease and diabetes developing. The lowering of triglyceride levels was attributed to the insulin sensitizing effects of curcuminoids.Further, the study also showed that Curcumin-BioPerine supplementation was safe and well-tolerated in obese subjects. Effects of triglyceride lowering can be beneficial in obesity, metabolic syndrome and cardio vascular diseases.

Also a dose of 1 g/day of C3 Complex was found effective in reducing oxidative stress burden.2 

In another study performed by Tufts University, the safety of composition of Curcumin C3 Complex and BioPerine was studied. The results showed that use of BioPerine and Curcumin C3 Complex is safe and unlikely to cause any significant interaction with drugs such as Midazolam (CYP3A substrate), flurbiprofen (CYP2C9) or paracetamol/acetaminophen (UGT and SULT substrate).3 

In a fourth study, University of Rochester researchers showed oral C3 Complex reduced the severity of radiation dermatitis in breast cancer patients receiving radiotherapy.4 

Also C3 Complex was the active ingredient in an oral formulation tested tolerability and efficacy for oral mucositis (resulting from chemotherapy involving doxorubicin) in a clinical trial involving pediatric patients.5 

In a randomized, double-blind, placebo- controlled trial on sulfur-mustardinduced chronic pruritus, the researchers concluded that C3 Complex was effective in reducing pruritus severity score and other parameters including on the levels of substance P and antioxidant enzymes.6 

These clinical trials are but the most recent ones that were published on Curcumin C3 Complex in addition to several other earlier ones.

References:

1 A Mohammadi et al. Phytotherapy Research. 2013: 27(3): 374-37. 

2 A Sahebkar et al. Phytother Res. 2013 Mar 15. doi: 10.1002/ptr.4952. 

3 LP Volak et al. Br. J Clin Pharmacol. 2012: 75(2): 450-462. 

4 JL Ryan et al., Radiat Res. 2013: 180(1):34-43. 

5 S Elad et al., Altern Ther Health Med. 2013: 19(3):21-4. 

6 Y Panahi et al., Br J Nutr. 2012, 108(7), 1272-9.