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Special Report: Branded Nutritional Ingredients

Kaneka
 
EuroMedica

Offering readers insight on the clinical backing and strategic development that has gone into top-tier ingredients.

Abranded ingredient on a finished product label has became shorthand for 1) an ingredient’s uniqueness and/or how it is produced, 
2) scientific studies back its safety and efficacy, 3) GRAS (generally recognized as safe) status is approved in the United States, and 4) it likely has clearance to be marketed in other countries as well. All of these components make them more appealing than their generic counter parts.

Here, Natural Practitioner examines four branded ingredients meticulously developed to meet the needs of four major health categories: stress, digestion, menopause/women’s health and cardiovascular.

Lactium from Pharmachem Laboratories

According to the 2010 Stress in America survey conducted by the American Psychological Association (APA), 44 percent of American adults said their stress levels have increased over the past five years. This type of unrelenting stress carries serious physical consequences, ranging from occasional problems sleeping, indigestion, weight gain, hormonal balance and reduced libido, said the APA.While Americans understand that this is not healthy, efforts to make changes can also be viewed as overwhelming and stressful.

“Practitioners know from patient feedback that prescribed antidepressants and anxiolytics often cause side effects.While these pharmaceuticals may indeed be effective, some practitioners may be interested in an integrative approach,” said Mitch Skop, senior director of new product development for New Jersey-based Pharmachem Laboratories, Inc., exclusive North and Latin America marketer of Lactium, a specific milk protein hydrolysate developed in France by Ingredia.

The ingredient was formulated to address stress reduction and healthy stress management, which in turn, also promotes normalized sleep onset and sleep quality. It is a food-grade, patented product that received the Bronze Award for the Best Innovation in Health Ingredients 2004 during the Health Ingredients Europe (HIE) exhibition. In addition, Lactium is not addictive, and doesn’t cause the often severe side effects of drugs used for stress management, according to Skop.

“While there are a number of herbal extracts marketed for stress such as valerian, passion-flower and lemon balm, there is very little research on their effectiveness,” he said. “Meanwhile, Lactium has been shown to be effective in six separate studies on more than 230 volunteers, and has GRAS and NDI (new dietary ingredient) approval.” 

One research milestone for Lactium was a double-blind, placebo-controlled study, published in the European Journal of Nutrition, conducted on 42 male subjects to determine responses to mental and physical stress. Results showed that systolic and diastolic blood pressure was significantly reduced and blood cortisol levels decreased significantly in subjects receiving Lactium.1 

Additional scientific substantiation demonstrating and confirming dosage include:

• In a 30-day trial, “Long-Term Effects of a Bovine áS1-Casein Hydrolysate on Healthy Low- and High-Stress Responders,” 50 subjects underwent mental stress tests. Results showed that Lactium, at a dosage of 150 mg/day, significantly reduced the blood pressure response to stress on Day 11 and Day 31. There were no side effects reported (e.g., change in heart rate, change in reactivity, adverse reactions).

• A double-blind cross over study, “Anti- Stress Efficacy of Lactium on Stressed Women,” was conducted over a 30-day period on 63 female volunteers showing at least one stress symptom. Those subjects receiving Lactium (dosage 150 mg/day) had a significantly greater improvement in stress symptoms (vs. Placebo) in the following areas: digestive, intellectual, social, cardiovascular and emotional. The effect of Lactium was greater in subjects having a high intensity score for a major symptom at the beginning of the study.

• A study, “Efficacy of Lactium on Sleep Disorders,” was conducted on 44 healthy Men and women with difficulty sleeping. Subjects were given 150 mg of Lactium per day for four weeks. Results showed that Lactium improves sleep duration and efficiency, especially in subjects with a moderate anxiety or depression profile, and reduces daytime sleepiness.

Skop noted that Pharmachem welcomes an open dialogue with practitioners— encouraging them to ask for the research portfolio and speak with its formulation experts. “Practitioners know how to interpret journal science and other clinical research. Therefore, practitioners are a gold-standard client for us,” he said. “In addition, practitioners should know that supplements such as Lactium support the body’s own ability to address stress and sleep, it does not cure or treat. This DSHEA knowledge does fall under value because it is absolutely pivotal and critical in how the practitioner sells his/her Lactium supplement to patients as part of a full treatment protocol.”

LactoSpore from Sabinsa

The American Gastroenterological Association reports that nearly 50 percent of the U.S. population has digestive issues that impact their personal and professional lives. From acid indigestion, reflex and regurgitation; to constipation, Crohn’s disease, diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) and more, digestive distress has been reported to affect more than 95 million Americans.

For those affected by conditions such as IBS, traveler’s diarrhea, infective diarrhea, lactose intolerance or inflammatory bowel conditions, New Jersey-based Sabinsa Corporation offers LactoSpore, a GRAS probiotic product that can help in maintaining healthy flora in the gastrointestinal (GI) tract.

While probiotics are a common approach to addressing digestive distress, not all are created equal. LactoSpore is differentiated in it contains Bacillus coagulans, a spore-forming bacteria. “By forming spores, the B coagulans bacteria are able to survive the harsh manufacturing process and have longer shelf life. The non-spore forming bacteria, such as L acidophilus, has a short shelf life and require special packaging and storage conditions,” said Anurag Pande, PhD, Sabinsa’s vice president of scientific affairs. “B coagulans can survive the acidity of stomach and bile acids and digestive enzymes and germinate in the intestine. B coagulans produces the favored L(+) lactic acid and effectively prevents the growth of pathogens. B coagulans also produces the bacteriocins, which are inhibitory toward gram (+) and gram (-) bacteria and maintains healthy gut flora.” 

The company established a biotechnology unit at Neelamangala, near Bangalore, India, dedicated solely to developing and manufacturing the B coagulans spore product. The team of scientists/microbiologists at this unit are responsible for the maintenance of purity and quality of the product, proper handling of the LactoSpore, standardization and quality testing, and packaging of the material, according to Dr. Pande.

The scientific substantiation for LactoSpore begins with a clinical study with a duration of two to 20 days conducted in Japan where 567 subjects in independent health care institutions were given 50-750 million CFU/day. The results: 85.9 percent of subjects showed improvement in maldigestion accompanied diarrhea cases, 87.9 percent of subjects showed improvement in infantile diarrhea, 65.4 percent of subjects showed improvement in constipation and 
93. 7 percent of subjects showed improvement in diarrhea due to acute or chronic gastroenteritis.2 

In a study published in Nutrition Research, 112 newborn infants were randomized to receive a daily oral dose of 100 million L. sporogenes or a placebo for one year. The number of diarrheal episodes, the duration of each episode as well as the recurrence of these episodes were reduced considerably.3 

Another study examined 60 subjects with diarrhea who were given 15 million L. sporogenes spores per day. The average recovery time was less than two days and showed 81.7 percent success rate in treating cases of diarrhea.4 

As a part of ongoing work on probiotic therapy, the scientists at Sabinsa came up with concept of using LactoSpore in a synbiotic supplement—branded as LactoWise— that contains both probiotic as well as prebiotic (Fenumannans).

Dr. Pande noted when practitioners are vetting products it is important to consider the clinical efficiency, stability of the product, history of the product and safety of its use. In case of the probiotics, he said the shelf life stability is important otherwise the benefits of the probiotic micro-organism may not be able to reach to the end consumer.

EstroG-100 from Helios CORP

According to www.menomission.com, a website dedicated to a community of women aged 40 years and up, 37.5 million women are currently reaching or are in menopause in the U. S. Menopause is not just hot flashes—there are 10 active symptoms plus vaginal dryness that affect women in different ways, and research is showing that the traditional therapies, such as hormone replacement therapy (HRT) and phytoestrogens, pose potential health risks.

Helios CORP, based in New Mexico, offers a safe, natural and proven alternative for pre-, periand post-menopausal sufferers with its EstroG-100, according to CEO Michael Jeffers.

“EstroG-100 is combination of three herbal extracts that have been developed by screening 71 herbal extracts via nonreproductive tract target tissue response (E-screen test) for their effects on menopausal symptoms. These effects have been proven by two double-blind, placebocontrolled, human clinical trials. At both clinical trials, EstroG-100 resulted in significant improvement of menopausal symptoms, without any significant side effects,” he said.

The Phase I double-blind, placebo-controlled human clinical was a 12-month study conducted in Seoul, Korea and included 47 women, while the U.S.-based Phase II double-blind, placebo-controlled human clinical was a three-month study that included 61 women. Both studies showed significant improvement with menopausal symptoms, such as hot flashes, vaginal dryness, insomnia, nervousness, depression, pain and other symptoms, without any significant side effects and changes in osteocalcin, alkaline phosphatase, hGh, cholesterol, L/H DL, triglyceride, FSH, E2, fasting glucose, weight, BMI, protein albumin and serum safety factor.

Published in Phytotherapy Research5, a 12-week treatment with EstroG-100 showed a statistically significant improvement in the various menopausal symptoms such as hot flashes, night sweats, paresthesia, insomnia, nervouseness, melancholia, vertigo, fatigue, rheumatic pain and vaginal dryness, compared with the placebo group. No adverse effects were reported with EstroG-100, and there were no significant changes in body weight, BMI, serum E2 levels, serum FSH levels or liver enzymes (all of which have previously been observed with hormone replacement thereapy). In this clinical trial, the authors wrote “EstroG-100 appears to be an effective and safe dietary supplement for use in pre-, peri- and post-menopausal women.” 

The EstroG-100 story is a long one that Jeffers notes is best outlined on a comparative basis in the Safe Menopause Story (www.safemenopause.com). “When we signed off on the Safe Menopause Story, it was evident that what we had been communicating to our customer base was coming to fruition: A variety of products on the market were [created] 10 years ago. Thus the level of scrutiny and evaluation was less than perfect. Times have changed and these lesser products can pose legitimate risks to consumers. EstroG-100 does not have this problem because of the extent of our science,” said Jeffers. “Once we understood we had something special post Phase II human clinical study where nine of 11 end point claims increased significantly, we invested to prove anti-cancer, liver protective, non-estrogenic, four- and 13-week toxicity studies and three genetic toxicity studies. Clinical results show multiple endpoint claims, quite a bit safer than other choices, and the ingredient is 100 percent natural.” 

EstroG-100 is a blend of hot-waterextracted herbs from Phlomis unbrosa, Cynanchum wilfordii and Angelica gigas Nakai (Korean Angelica). Its active ingredients are triterpene glycoside (Shanzhiside methyl ester) from Phlomis unbrosa, and wilfoside and cyanuricoside from Cynanchum wilfordii. It also contains decursin extracted from Anglica gigag Nakai.

Helios CORP established standardized protocols for each of the three extracts and during the NDI filing process, and had the U.S. Food and Drug Administration (FDA) validate said protocols for each of the three water-based, natural extracts. Today, this represents the testing guidelines for the ingredients, according to Jeffers.

“We cooperate with our manufacturing team members along with quality control consultants in establishing standardization protocols of each component that might end up in our finished products. In the case of EstroG-100, we developed diligent guidelines to quantify the active components per root extract,” he said.

Tocomin Suprabio from Carotech, Inc.

Stroke is now the fourth most common cause of death in the U.S., according to the Centers for Disease Control and Prevention (CDC). The American Heart Association (AHA)6 reported that each year, 795,000 people experience a new or recurrent stroke. Mortality data from 2007 indicate that stroke accounted for one of 18 deaths in the United States. 

Dyslipediemia and hypertension are some of the main risk factors contributing to cardiovascular diseases, the No. 1 cause of death globally. Data from the National Health and Nutrition Examination Survey (NHANES) 2005-08 indicate that an estimated 7.64 million U. S. adults have hypertension, while 3.36 million have high total blood cholesterol levels.6 

Tocomin SupraBio, a bio-enhanced natural full-spectrum palm tocotrienol complex from New Jersey-based Carotech, Inc., was been developed to support cardiovascular systems. It is the main tocotrienol complex used in clinical trials and shown to have positive beneficial effects in conditions such as stroke (against stroke-induced injuries and funded by NIH), hypercholesterolemia, hypertension and arterial compliance, According to Bryan See, regional product manager with Carotech, Inc. 

“Tocomin SupraBio is the most used tocotrienol ingredient in scientific research for the last five years,” he said, noting that it is the only branded tocotrienol ingredient that has proven human tissue distribution study that its bioavailability7-9 and distribution in significant levels to vital tissues and organs.10 “The patent, unique attributes as well as bring backed by human clinical studies are what differentiate it from other generic oil extracts in the market.” 

In a study published in 2011″1, the double-blind, placebo-controlled clinical trial reported that subjects with high blood cholesterol who received Tocomin SupraBio demonstrated significant reduction in total and LDL-cholesterol levels by the fourth month of supplementation. Continuous significant reduction was seen on the fifth and sixth months. In contrast, subjects in the placebo group had negligible changes in their total and LDL-cholesterol levels compared to baseline. This published paper showed that supplementation with Tocomin SupraBio for six months resulted in significant reductions of LDL-cholesterol concentrations in human with high cholesterol level (approximately 17 percent respectively).

A randomized, controlled clinical trial demonstrated that oral supplementation of Tocomin SupraBio for two months reduced arterial stiffness in healthy adults.12 In this blinded endpoint clinical trial conducted by researchers in the University of Science, Malaysia, 36 healthy volunteers were randomized to receive either a placebo, 50 mg, 100 mg or 200 mg self-emulsifying tocotrienol complex (Tocomin SupraBio) daily for two months. The results showed that treatment with Tocomin SupraBio self-emulsifying tocotrienol complex produced significantly higher plasma concentrations of tocotrienols compared to placebo. After two months of supplementation, statistically significant improvement in Augmentation Index (up to 8.7 percent reduction from baseline) was observed in all the tocotrienols supplemented groups. Significant improvement in pulse wave velocity (up to 10 percent reduction from baseline) was also seen in subjects who received 100 mg and 200 mg Tocomin SupraBio self-emulsifying palm tocotrienol complex.

Carotech is currently the only GMPcertified tocotrienol producer in the world, and the company prides itself on the stringent pharmaceutical GMP guidelines for all processes, including implementation of in-process quality control (IPQC). “This ensures quality sampling and checks are carried out throughout the production process and allow early detection of inconformity, hence corrective and preventative actions can be initiated immediately,” said See. “Furthermore, Carotech’s in-house laboratory has ISO/IEC 17025 accreditation, which demands for an established quality system to be in place and demonstrating technical competency of our laboratory staff in performing specific analytical testing.” 

In closing, as practitioners vet products, See offered his bottom line: “Read and ask for the published papers (in peer-reviewed journals) and stem out borrowed science. In addition, product certifications (such as GMP and kosher) are important to ensure quality and consistency.”

References: 

1 Messaoudi M, et al. Effects of a Tryptic Hydrolysate from Bovine Milk ƒ¿S1-Casein on Hemodynamic Responses in Healthy Human Volunteers Facing Successive Mental and Physical Stress Situations. Eur J Nutr. 2005 Mar;44(2):128-32. Epub 2004 Nov 2.

2 Abstracts of paper on the clinical study of Lacbon (Sporlac) compiled by Sankyo Co. Ltd Japan.

3 Chandra, RK. Effect of Lactobacillus on the incidence and severity of acute rotavirus diarrhea in infacts. A prospective placebo-controlled, double-blind study, Nutrition Research 22 (2002) 65-69.

4 Dhongade RK, Anjaneyulu 1977. Abstract from Maharashtra Medical Journal, Vol XXIII No. 1, 473-474.

5 Albert Chang, Bo-Yeon Kwak, Kwontaek Yi and Jae Soo Kim, The Effect of Herbal Extract (EstroG-100) on Pre-, Peri- and Post-Menopausal Women: A Randomized Double-blind, Placebo-controlled Study. Phytotherapy Research 26: 510-516 (2012). Published online 2 September 2011 in Wiley Online Library DOI: 10.1002/ptr.3597. 

6 Circulation 2011, 123:459-463.

7 Pharmacokinetics and bioavailability of ƒ¿., A- and ñ-tocotrienol under different food status, J. of Pharmacy and Pharmacology, 2001, 53 : 67-71.

8 Influence of route of administration on the absorption and disposition of ƒ¿., Aand ñ-tocotrienol, J. of Pharmacy and Pharmacology, 2003, 55 : 53-58 9 US Patent No : US 6,596,306; July 22 2003. 

10 Patel V, et al. gOral Tocotrienols are Transported to Human Tissues and Delay the Progression of the Model for End-Stage Liver Disease Score in Patients.h The Journal of Nutrition 142, no. 3 (2012): 513- 9.

11 KH Yuen et al. gEffect of Mixed- Tocotrienols in Hypercholesterolemic Subjects.h Functional Foods in Health and Disease 3 (2011): 106-117.

12 Rasool, AHG et al. gArterial compliance and vitamin E blood levels with a self emulsifying preparation of tocotrienol rich vitamin E.h Arch Pharm Res Vol 31, no. 9 (2008): 1212-1217.

FOR MORE INFORMATION:

Carotech, Inc., (732) 906-1901,
www.carotech.net, www.tocotrienol.org

Helios CORP; (505) 982-8836,
www.helioscorp.com,
www.safemenopause.com

Pharmachem Laboratories, Inc.,
(800) 526-0609,
www.pharmachemlabs.com

Sabinsa, (732) 777-1111,
www.sabinsa.com, www.lactospore.com