Wellmune

In anticipation of his presentation as part of the Preventative Health and Immunity session at Vitafoods Europe in May, Biothera’s Don Cox, Ph.D., senior vice president, Healthcare Group R&D, Biothera, offers 10 tips for evaluating immune health ingredients. For more information on the program visit http://www.vitafoods.eu.com/conference.

Dietary interventions to support immune health are bringing new excitement to the food and beverage industry. Here are 10 factors to consider when evaluating immune health ingredients:

1. Ingredient safety: Ensure that the ingredient has safety data published in a peer-reviewed toxicology journal and reviewed by EFSA (EU), the US FDA and/or other leading regulatory agencies. Request and review the government’s regulatory letters.
2. Mechanism of action: Studies should be conducted in a manner that demonstrates the mechanism of action as measured by its effect on the innate or acquired immune system. Independent, peer-reviewed, published research is best.
3. Method of boosting: Some immune boosters provide temporary stimulation and create an artificial and unnatural state that may damage the body if taken too long. Others safely boost the body’s natural immune mechanisms to respond to a challenge, maintain immune system balance and can be taken year-round.
4. Quality and quantity of the clinical research: Look for multiple peer-reviewed, published, high quality studies with consistent outcomes. Peer-reviewed, double-blinded, placebo-controlled clinical studies are the gold standard.
5. Research source: Examine whether the research was conducted with the specific ingredient or borrowed from other products. Borrowed science is junk science. The specific biological strain or chemical structure matters.
6. Study design: Design is important to eliminate unintentional bias. Understand and weigh the merits of single blind, open label, double blind, and crossover study designs. While all are valid designs, double-blind studies and crossover design eliminate data variations owing to the physical make up of each treatment group.
7. Outcomes employed: The major forms of outcomes of scientific and regulatory interest are biomarker outcomes and physical health outcomes. Many outcomes can be misinterpreted or are surrogates for the clinical endpoint. Outcomes in human clinical studies must have a demonstrable positive benefit for humans.  Outcome selection is not always clear cut.
8. Ingredient characterization: The health benefit activity must be attributed to known component(s) with well defined molecular structure.  Characterization allows for measurement and standardization required for establishing serving recommendations, consistency in manufacturing and stability and shelf-life testing. Identifying the active component is necessary for determining the desired health effect; it also provides confidence that the efficacy or stability is the same from batch to batch.
9. Serving size determination: Ensure that the ingredient’s dose-response data supports the recommended daily serving. A demonstration of dose response is the best indicator of optimum or effective serving.
10. Formulation characteristics: No matter how safe or effective the ingredient, it is essential that it can be formulated into foods and beverages so that the ingredient doesn’t break down and lose its potency if exposed to heat, pH or pressure required in the manufacturing process.  It is critical that appropriate analytical methods be available to quantify the amount of the ingredient present in the food or beverage after processing and at the end of the projected shelf life of the product.

EAGAN, MN – Jan. 21, 2013 – Wellmune WGP^®, the natural immune health ingredient from Biothera, is now available in MediChá^®, a functional beverage in Taiwan made by U!be Group Inc., a leading innovator in the health and wellness category. MediChá^® is a unique tea concentrate shown to address the health concerns of people with metabolic syndrome.

Wellmune WGP is clinically proven to safely prime the immune system to keep the body healthy. Numerous peer-reviewed clinical studies demonstrate that Wellmune WGP mobilizes billions of innate immune cells that are part of the body’s natural defenses without artificially stimulating the immune system.

“We are excited that U!Be Group is expanding its offering and bringing Wellmune to the Chinese community through the tradition of drinking tea. MediChá with Wellmune is a perfect match of ancient wisdom of the East with a nutritional breakthrough from the West,” said Richard Mueller, chief executive officer, Biothera.

“MediChá synergistically combines the immune-strengthening mechanism of Wellmune and scientifically validated ingredients to help optimize glycemic response into a unique preparation of Pu-erh Tea concentrate from hundred-year-old tea trees,” added John Perng, Ph.D., U!be Group Inc.’s vice president of R&D and business development. “This triple combination of health benefits helps to enhance the immune system, promotes healthy metabolism and supports overall health.”

Mueller added, “MediChá with Wellmune is a great example of how beverage companies can create added value for their brand. Immune support is one of the most sought-after functional health benefits.”

About U!be Group Inc.

U!be Group Inc. is a pioneer in creating innovative nutraceutical products featuring clinically-proven nutraceutical ingredients and novel delivering systems. The company’s goal is to provide natural solutions to health problems with its U!be brand of products that is efficacious yet affordable to the general public. For more information visit www.ubelife.com.

About Wellmune WGP^®

Wellmune WGP is a proprietary baker’s yeast beta 1,3/1,6 glucan that is clinically proven to prime key immune cells that keep the body healthy. This natural food, beverage and supplement ingredient has regulatory approval around the world, including GRAS status in the U.S. and novel foods approval in Europe and China. Wellmune is available in more than 100 products in more than 50 countries around the world. It is also patented, Kosher, Halal, non-allergenic and GMO-free. In addition to receiving an IFT Innovation Award, Wellmune has received a SupplySide West Scientific Excellence Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
dwalsh@biothera.com

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Elaine Watson of Nutraingredients-USA.com caught up with Rich Mueller, Biothera healthcare group president, to discuss the challenges manufacturers face to support immune health claims. Mueller noted that using vitamins and minerals is not enough and that it takes ingredients based on numerous clinical studies demonstrating the direct correlation between a specific ingredient strain and the immune health benefit. The story also included mention of Praeventia Cookies with Wellmune WGP from Biothera now available at 500 Walmart stores.  Biothera” ‘Using vitamins and minerals alone to support immune claims is not enough’

EAGAN, MN – March 5, 2012 – MonaVie, a leading product innovator in the health and wellness category, has selected Wellmune WGP^®, the natural immune health ingredient from Biothera, for its newest health juice, Monavie MX™. The introduction builds upon MonaVie’s product family of ready-to-drink beverages, sachets and shots that include Wellmune WGP.

Wellmune WGP is clinically proven to safely prime the immune system to keep the body healthy. Numerous peer-reviewed studies demonstrate that Wellmune WGP mobilizes billions of innate immune cells that are part of the body’s natural defenses without over stimulating the immune system.

“We are gratified that MonaVie has chosen to expand its offering of good-for-you beverages with Wellmune WGP. The line extension underscores both market acceptance of products with Wellmune as an ingredient and its flexibility to meet a range of formulation requirements,” said Rich Mueller, Biothera president and chief executive officer.

Described as offering a powerful punch of antioxidants, including 19 fruits and 11 vegetables, MonaVie MX is formulated with MonaVie BioEssence™ technology, which provides greater bioavailability, and features AçaVie™, the most potent form of açai available.

“MonaVie MX is the ultimate juice blend,” said Shawn Talbott, PhD, and MonaVie’s vice president of product research and development. “It synergistically combines the immunity-strengthening defense of Wellmune with scientifically validated glucosamine to increase joint mobility and a broad array of powerful antioxidants. This triple combination of health benefits helps safeguard the body against potentially harmful microorganisms, promotes joint health and fights oxidative damage and aging.”

Mueller added, “As consumers look for more ways to support their health and vitality, the broader availability of clinically proven Wellmune WGP in brands they trust offers peace of mind and worry-free convenience that contributes to healthy habits for a lifetime.”

About Wellmune WGP

Wellmune WGP is a natural carbohydrate that is clinically proven to prime key immune cells that keep the body healthy. This unique food, beverage and supplement ingredient is Generally Recognized as Safe (GRAS) under U.S. FDA regulations. It is also patented, Kosher, Halal, non-allergenic and GMO-free. The ingredient is a recipient of an IFT Innovation Award and a Frost & Sullivan Excellence in Research Award. Wellmune WGP is a product of Biothera, a U.S. biotechnology company dedicated to improving immune health.

About MonaVie

MonaVie is a leading product innovator in the health and wellness category. Starting with the açai berry, MonaVie has fulfilled its mission to bring the rarest and most efficacious nutritional products to a global market. Its reputation as an innovative leader has been confirmed again with the introduction of its revolutionary new product philosophy, MonaVie Nutritional Chemistry™, that delivers custom nutrition to meet an individual’s unique nutritional needs in an easy-to-use delivery system. Learn more about MonaVie at www.monavie.com.

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You’ve probably seen product information statements on supplements sold online or in stores. Sometimes the terms used in those descriptions, or on the labels, can be unclear or downright confusing! Here’s a glossary of commonly used terms and their significance.

Research Terms

Bioavailability – The rate at which our body absorbs a nutrient. If the bioavailability is too low, the nutrient might be expelled from our bodies before we can get its benefit.

Clinically proven – The product/ingredient has tested in a clinical study to see how it works in people, and the results support the health claim(s). To evaluate a “clinically proven” claim, look for multiple double-blind, placebo-controlled studies using that specific brand, that were conducted by university-level experts in that research field. Be sure that the product includes the same efficacious serving sizes used in the clinical studies.

Human clinical research – Research done using people as subjects. Participants are generally within a subject group that researchers believe are likely to benefit from the ingredient or product being tested.

In-vitro research – Research conducted on organs, tissues or cells outside of the living body.

In-vivo research – Research conducted on organs, tissues or cells within the living body.

Pre-clinical research – A stage of research that begins before clinical trials (testing in humans) can begin, and during which important data is collected.

Regulatory Terms

Efficacy – A measure of how effective an ingredient or supplement is at delivering its benefit.

Food grade – Meets standards set by the U.S. Department of Agriculture for human consumption.

GRAS-approved – “Generally recognized as safe” means the U.S. Food and Drug Administration agrees with the opinion from an independent panel of experts, which has reviewed science and safety data and determined that an ingredient or product is safe. The FDA issues “no objection” letters when it reviews a voluntarily submitted self-affirmed GRAS dossier and has no objections to the finding of the GRAS panel of experts.

Kosher – Foods or food products that have been processed in accordance with Jewish Dietary laws. In addition to religious and ethnic considerations, a Kosher certification may also be perceived to indicate higher quality.

GMO – Genetically modified organisms. Some nutritional supplements are GMO-free or will specify they are non-GMO. This means that no alteration was made to DNA of the food product used in an ingredient or supplement. Some groups are concerned that there is too little known about the long-term health impact of eating genetically modified foods.

Immune boosters – Also known as immunostimulators, these are substances such as herbs, vitamins and minerals that can stimulate the immune system to grow and multiply the number of infection-fighting cells in the body.

Naturally derived – A product that contains ingredients derived from nature with minimal processing.

Naturally occurring – An ingredient that is delivered in its natural form.

Other Important Terms

Nutraceutical – A combination of the words “nutrition” and “pharmaceutical,” it refers to any substance that is a food or part of a food and provides medical or health benefits.

Non-allergenic – Will not cause an allergic reaction.

Pharmaceutical grade – A term commonly used to indicate that the ingredients used in a supplement meet the highest standards for purity and concentration. The product must be at least 99 percent pure, without additives or unnecessary substances.

Monograph – Official standards that specify the kinds and amounts of ingredients that a drug or substance may contain, the directions for its use, the conditions in which it may be used, and any reasons to withhold its use. Monographs are published by the United States Pharmacopeia (see below).

United States Pharmacopeia (USP) – The USP is a nonprofit, scientific organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. More than 130 countries rely on USP standards.