A randomized, triple-blind, placebo-controlled clinical trial involving supplementation with a bioflavonoid ingredient UP446 provides evidence for a robust, healthy immune response in healthy adults following influenza vaccination.
VANCOUVER, British Columbia--(BUSINESS WIRE)--Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics as supported by clinical research, announced today that a clinical study conducted by its wholly owned subsidiary KGK Science Inc. (“KGK”), has shown positive results of UP446 supplementation in helping mount a robust immune response following influenza vaccination.
UP446, a natural health ingredient developed by Unigen Inc. (“Unigen”), contains Acacia catechu and Scutellaria baicalensis, botanicals with antioxidant and anti-inflammatory properties; however, this is the first study to examine these ingredients using a human vaccine model. The randomized, triple-blind, placebo-controlled clinical trial involving supplementation with bioflavonoid composition UP446 provides evidence for a robust, healthy immune response in adults following influenza vaccination.
Healthy adult participants, who had not yet received their influenza vaccine, between 40-80 years of age were randomized to either UP446 or placebo for 56 days. Halfway through the study, at day 28, participants received a flu vaccine. The results, published in Journal of the American Nutrition Association, showed that supplementation with UP446 significantly increased levels of IgA and IgG antibodies compared to placebo in the post-vaccination period. Influenza-specific IgG antibodies significantly increased with UP446 supplementation from Day 28 to 56 and from baseline at Day 56. Blood levels of glutathione peroxidase, part of the antioxidant defense system, were significantly increased in the pre-vaccination period suggesting UP446 may help improve antioxidant functions in conjunction with vaccination.
“Conducting gold-standard clinical studies is critical in furthering our understanding of the complex interactions between natural health products and immune function” says Dr. Erin D. Lewis, Scientific Director at KGK Science. “Using a vaccine model provided a unique and novel way to examine the effect of UP446 supplementation on the immune response”.
Unigen president and CEO, Dr. Qi Jia, added “This study is a critical step toward providing consumers with scientifically based and safe ingredients and bringing natural health products to market as immune defense nutrients to support respiratory health in cold and flu season. This immune response plays an important role in a comprehensive vaccination strategy that can be applied across the entire spectrum of healthy population especially in an aging community.”
Future research on UP446 is warranted, prior to expanding the specific application of the ingredient, and will be undertaken to understand the effect on other immune cell populations, and in populations at increased risk of upper respiratory tract infections, such as older adults, teachers, and individuals with seasonal respiratory allergy.
ABOUT UNIGEN INC.
Unigen discovers, develops, and manufactures proprietary natural-product active ingredients for dietary supplements, cosmetic and personal care products, prescription medical food and botanical drug products. The Company discovers its ingredients through its high throughput screening PhytoLogix® approach applied to a proprietary well-annotated collection of botanicals and a legacy mining approach applied to botanicals having known medicinal benefits.
Mechanism of action, safety and efficacy are documented with extensive preclinical in vitro and in vivo testing and by human clinical studies. Unigen protects its discoveries with issued patents and patent filings in all major territories and manufactures its products to GMP standards. Unigen commercializes its proprietary ingredients through licensing and ingredient supply alliances with commercial partners engaged in the manufacture, distribution, and marketing of end-products in each of Unigen’s target markets.
ABOUT KGK SCIENCE
Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co.
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WELLBEING DIGITAL SCIENCES
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