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Brands With Backing

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K2VITAL®

Branded ingredients have gained distinction as ingredient manufacturers have invested in clinical trials and consumer marketing, as well as formed partnerships with major product manufacturers.For manufacturers, the benefits of a high-quality branded ingredient can be significant. Below are six examples of branded ingredients on the market, as NIE details how the companies behind them provide support and clarity.

PteroPure From Chromadex, Inc.

pTeroPure® was founded as a high quality brand of ChromaDex, Inc (Irvine, CA) to provide high purity pterostilbene to the dietary supplement, food, beverage, cosmetic, animal health and pharmaceutical industries. PteroPure is a nature-identical 99 percent pure alltrans pterostilbene. Pterostilbene, like resveratrol, is a natural compound found in small berries that acts as part of the plant’s defense system, and, according to Jeremy Bartos, PhD, senior product development manager at Chromadex, it has shown clinical promise in several health markets, including heart health, aging, cognitive function, memory and metabolism.

In one study published by the United States Department of Agriculture (USDA) in 2005, both pterostilbene and resveratrol were tested for the ability to induce PPAR-alpha activation.PPAR-alpha is involved in fatty acid and lipid catabolism and its activation leads to decreased triglyceride and very low-density lipoprotein (VLDL) synthesis; for example, the fibrate family of pharmaceuticals acts to decrease cholesterol levels through PPAR-alpha activation. The study showed that pterostilbene activated PPAR-alpha in vitro better than all compounds tested, including both resveratrol and the pharmaceutical ciprofibrate.

Subsequent structural and in vivo studies confirmed the correlation between pterostilbene’s activation of PPARalpha and cholesterol lowering.

According to Bartos, pTeroPure is the only pterostilbene on the market with completed safety and toxicity studies.This has led to self-affirmed generally recognized as safe (GRAS) status, demonstrating the safety of the ingredient, with a maximum daily allowable dose of 1,890mg; the average recommended daily amount of pTeroPure Ranges between 50mg and 150mg, Bartos said.

“With pTeroPure, manufacturers have access to the intellectual property that ChromaDex has licensed, including the right to market the products in the heart health, cognitive function, aging and anti-anxiety markets. With the culmination of the first human study on cholesterol finishing up and another planned, ChromaDex is planning to pursue a qualified health claim for pTeroPure and cholesterol, in a similar manner as the phytosterols qualified health claim for lowering cholesterol.”

As such, Jarrow Formulas (Los Angeles, CA) features pTeroPure in its standalone pterostilbene, in Resveratrol Synergy™ and in Resveratrol Synergy™ 200. It also will be included in an upcoming combination formula to be released later this year, said Dallas Clouatre, PhD, consultant for R&D at Jarrow.

Clouatre said that it has been very difficult to find a reliable generic source of the ingredient. “Even when the quality control has been adequate, there have been supply issues. Jarrow made Its choice partially in terms of simple reliability of supply and quality.”

Undoubtedly, Jarrow also believes in products that are backed by science and continued research. PteroPure has been and will continue to be the object of a growing volume of research, especially clinical research, said Clouatre.

“With commodities, which is to say generic sources of ingredients, the emphasis typically quickly deteriorates to mere questions of price. In contrast, branded ingredients are supported by investments in science and quality control. The name of a branded ingredient is something of value and the defense of this value is insurance for those who use branded ingredients.”

Advantra Z From Nutratech, Inc.

Advantra Z®, distributed worldwide exclusively by Nutratech, Inc. (West Caldwell, NJ), is an ingredient for energy, weight management and sports nutrition, and works by increasing thermogenesis— a proven method of weight loss and toning—to help burn calories and fat. It does this without causing Negative cardiovascular and central nervous system side effects.

Advantra Z is derived from bitter orange, which has been used for a variety of medicinal and dietary purposes for thousands of years. The ingredient primarily stimulates beta 3 receptors, which are found on every cell wall and are responsible for triggering thermogenesis.Thermogenesis increases the resting metabolic rate and the rate at which fat is released from body stores and broken down to help burn calories.

The only branded bitter orange extract on the market, Advantra Z’s superiority over generic bitter orange extracts is clear, according to Bob Green, president of Nutratech. Green explained that in contrast to branded bitter orange extracts, generic extracts have many deficiencies, including: they tend to isolate a single constituent; they may include m-synephrine, which has the potential for raising blood pressure in humans; they may incorporate synthetic synephrine; and there is inconsistent quality, unreliable supply and no clinical support.

“There is a wealth of research—more than 20 double-blind, placebo-controlled studies—supporting Advantra Z’s safety and efficacy,” said Green. “In fact, bitter orange is one of the most studied ingredients in the natural products industry. Most of these studies have used Advantra Z rather than generic bitter orange extracts because of its consistent quality.”

A big challenge Nutratech has had to overcome with Advantra Z is dealing with the media, who, according to Green, have made bitter orange one of their favorite “whipping boys,” with its safety frequently called into question.

Green said that this notion should be dispelled now that researchers have published 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 p-Synephrine, HerbalGram, 2011). The article concludes that, based on current research and the extensive ingestion of products containing bitter orange, Advantra Z is Safe for human consumption and that challenges to the safety of this ingredient are without scientific basis, said Green. “The researchers go so far as to state that those who question the safety of the patented bitter orange extract, Advantra Z, ‘either lack understanding of the chemistry of bitter orange or have failed to carefully review the scientific literature.’”

Manufacturers can maximize the use of Advantra Z in their formulas by featuring the logo on packaging. “It’s a clear marketing advantage,” said Green. “The Advantra Z logo tells both retailers and consumers that research, quality controls/testing and patents back this branded ingredient. Plus, companies that place the Advantra Z logo and patent/trademark statement on the product label can receive a marketing allowance.”

Zychrome From InterHealth Nutraceuticals 

Interhealth Nutraceuticals (Benicia, CA) is a company that believes in branding as a key strategy. “It helps to differentiate our products in a crowded environment,” said Paul Dijkstra, Interhealth’s CEO. The company’s key brands are backed by strong clinical research that support unique and value-added product claims. “Lack of science in a tough market like this can be detrimental, especially in an environment of rising regulation. I’ve seen many brands introduced into the market without adequate efficacy or safety data necessary to support long-term success.”

Interhealth’s Zychrome™ is a unique, patent-pending chromium complex consisting of chromium, niacin and Lcysteine (chromium dinicocysteinate).Published preclinical research demonstrates that Zychrome increases blood sugar control and insulin regulation, and decreases inflammatory markers and oxidative stress. Decreasing these markers ultimately increases insulin control and increases glucose transport into cells.

Zychrome was examined in a randomized, double blind, placebo-controlled study to determine its effect on insulin, insulin resistance and other benefits compared to chromium picolinate. Subjects took Zychrome, chromium picolinate (each providing 400mcg of elemental chromium) or a placebo daily for 12 weeks.Preliminary results from this clinical study showed that Zychrome significantly reduced fasting insulin levels at week 12 over baseline, resulting in a 30 percent reduction, said Dijkstra.

Dijkstra expressed he feels strongly that Zychrome will reinvigorate the blood sugar market as the next generation in chromium supplementation. “Manufacturers are searching for something that is effective, safe and has significant impact on consumer’s health. The clinical results we’ve seen as well as the published preclinical data are very promising. This is a step in the right direction in managing insulin function and ultimately blood sugar control for millions of Americans.”

Wellmune WGP From Biothera 

According to Richard Mueller, president and CEO of Biothera (Eagan, MN), Wellmune WGP® is a one-of-a-kind technology. “This proprietary compound has more than $300 million invested in research and development.This investment has demonstrated safety and efficacy, making it a premium ingredient worthy of its own brand.” 

Wellmune WGP is a natural food, beverage and supplement ingredient that is clinically proven to safely enhance the immune system and help keep the body healthy. Derived from a proprietary strain of yeast, Wellmune WGP is a gluco polysaccharide that mobilizes billions of innate immune cells that are part of the body’s natural defenses. This unique immune health ingredient helps increase the effectiveness of these immune cells without stimulating the immune system, Mueller said.

Once swallowed, immune cells in the gastrointestinal tract take up Wellmune WGP and transport it throughout the body. Fragments bind to receptors on all neutrophils, which are the most abundant immune cells in the body, accounting for over half of all immune cells. Activated by Wellmune WGP, the neutrophils are now primed for activity. Priming means the neutrophil (immune system) will not be stimulated and does not act differently until a challenge is present. Then, with Wellmune WGP, the neutrophil will more quickly navigate to the site of a challenge in the body and more effectively kill it, Mueller explained.

There is plenty of research backing Wellmune WGP, including eight clinical studies that consistently show the ingredient’s ability to strengthen the immune system even during periods of high physical or lifestyle stress. “Wellmune WGP is safe and designed for daily consumption, making immune support a year-round activity rather than a seasonal product,” said Mueller.

Mueller added that manufacturers can maximize the use of Wellmune WGP just by use of the brand name. “More than 80 percent of the products containing Wellmune show the Wellmune brand logo on their packaging.Highlighting Wellmune WGP demonstrates for consumers the real, clinically proven immune health benefits of the finished product.”

Fast-C From Scientific Food Solutions, LLC 

Fast-C™ from Scientific Food Solutions, LLC (Fairfield, CA) is a premium, faster absorbing and well-retained vitamin C ingredient, which has been the subject of two U.S.-based, double-blind, randomized, crossover clinical trials. One double-blind, crossover human clinical study performed at a pharmaceutical lab in the U.S. demonstrated that Fast-C was absorbed faster and showed a higher rise in blood vitamin C with equal to better retention.

The ingredient utilizes a unique, patent-pending composition that provides a buffered and 90 percent+ acid neutralized vitamin C, delivering this vital nutrient with greater speed and excellent retention in an easily tolerated formulation that fosters greater consumer compliance. Fast-C contains BioPerine®, the patented bioavailability enhancement ingredient from Sabinsa Corporation, through a semi-exclusive licensing agreement.

According to Gretchen Reese, president of Scientific Food Solutions, the company entered the branded ingredients market due to a “desire to formulate superior ingredients that are truly efficacious with science to back the claims.” The ingredient enjoys significant intellectual property in the forms of patents, human clinical data and superior formulas, she said.

Manufacturers such as Purchase, Nybased Quality of Life Labs have found successful use of Fast-C. The company features the ingredient in its AdvaSorb™ Vitamin C, which is used to improve antioxidant status, detoxify a range of pollutants and provide an immune boost during the winter months, said Dan Lifton, COO of Quality of Life Labs. “Fast-C is better than the leading brand of vitamin C because it delivers 28-54 percent more vitamin C into the tissues in the first two hours (relative to baseline vitamin C levels) yet is equally retained by the body.”

When asked why the company chose branded ingredients over generic ones, Lifton pointed to clinical research and scientific backing.“Branded ingredients usually have clinical research because the manufacturers have a financial incentive to conduct human studies. For obvious reasons, manufacturers of commodity ingredients have a harder time justifying an investment in research when the spoils of their investment go to other manufacturers. Since clinical research is such a core focus for us, branded ingredients deliver value with the clinical research they bring.”

Lifton added that branded ingredients also help differentiate the product— often allowing companies to tell a unique story and positing them as a “better than” version of existing commodity ingredients.

Capismax From OmniActive Health Technologies 

According to Dr. Jayant Deshpande, CTO of OmniActive Health Technologies (Maharashtra, India), the company chose to enter the branded ingredients market because “its products are unique and have a great deal of brand appeal, thus allowing manufacturers to capitalize on the reputation that our brand brings.” 

OmniActive’s patent-pending Capsimax™ is a new development in capsicum technology that allows manufactures to include the beneficial amounts of capsicum, red hot peppers, to their weight management and sports nutrition formulas.

Capsimax utilizes OmniBead, OmniActive’s breakthrough beadletting technology, to deliver a fiery thermogenic pump without the burn. Each beadlet starts with an inert core, which is coated with premium, highly concentrated natural capsicum, followed by a controlled release outer coating that releases in the intestines and not the stomach. Using a proprietary matrix of excipients and coatings, Capsimax capsicum extract gives users the maximum effectiveness of capsacinoids without any oral or gastric irritation, thus solving the problem of capsicum compliance, said Deshpande.

“There is a notable trend happening toward ingredients that are scientifically validated and safe, showing a definitive shift from weight management and sports nutrition products that are either dangerous or that just don’t work. Manufacturers will be able to include an effective and safe ingredient with Capsimax.”

Additionally, unlike many ingredients, capsicum and capsacinoids have a long line of history, said Deshpande. “Not only have capsicum and capsacinoids been a dietary mainstay around the world for hundreds of years, but in the past 30 years, they have also gained an increasingly impressive reputation as safe and effective ingredients to support weight management and sports nutrition. In animal and human studies, capsicum and capsaiciods have been shown to help manage appetite, support healthy metabolism by burning calories, help induce thermogenesis (increase in energy expenditure in the body), and support lipolysis.”

CapsCanada
 
K2VITAL®