Thorne Research Inc., a leader in developing and manufacturing pure, high quality nutritional supplements, announced a new dietary supplement clinical study agreement with Mayo Clinic. Starting in January 2015, Thorne Research and Mayo Clinic will begin conducting a series of randomized double-blind placebo-controlled clinical trials on a number of dietary supplements, under a master clinical study agreement. Working with physicians and Ph.D. scientists, trials will be conducted at Mayo Clinic, with the intent of raising the bar on dietary supplement research, leading to improved patient outcomes.
“The studies are designed to test the safety and efficacy of a range of single compounds from natural sources, plant extracts with complex molecular attributes, and complex nutritional products formulated to address specific nutritional needs,” said Robert Rountree, MD, chief medical officer of Thorne Research. The primary focus will be to test materials that are considered GRAS (Generally Recognized as Safe) within the FDA designation, and to emphasize the understanding of mechanism of action, safety, pharmacokinetics, and optimal dosage for these products.
Trials will involve conditions with significant human need, sports related performance, recovery and injury and nutritional support for pre- and post- surgical care. The results will be used to develop supplements, medical foods, functional foods and botanical drugs.
Thorne also intends to refine and test leading formulations from Traditional Chinese Medicine. There is a need to standardize Chinese botanical mixtures for their multiple molecular active components, to assure the biological activity of the finished products, and to assure that the finished TCM products are free of pesticides, herbicides, and adulterants. Thorne plans to run clinical trials and potentially work with partners from China to take advantage of centuries of knowledge in this field.
In December of 2013, Thorne Research acquired a minority interest in the web- and mobile-based platform WellnessFX, which facilitates blood analysis and data display for use in individual, corporate, clinical, and other settings. This platform is available for use in research studies conducted through the clinical study agreement with Mayo Clinic. Thorne is particularly interested in the use of the WellnessFX platform in telemedicine and personalized care to take advantage of the potential to enhance the doctor-patient experience, with further applications in corporate and individual wellness, disease management, and athletic training.
According to Paul Jacobson, CEO of Thorne Research, “The natural product sector is poised for a dramatic transition in public acceptance and public scrutiny. This is driven, in part, by a phenomenon influenced by corporate decision makers. In surveys of consumers, 60 to 80 percent of people state that they use nutritional supplements. This situation presents a dilemma for corporate entities, such as athletic organizations, corporate wellness programs, medical practices, health care providers, consumer membership organizations, and many others. On the one hand, these groups know their people use supplements, but they worry there is a wide range of quality, safety, and efficacy. Recommending specific supplement lines is a risk they’ve traditionally avoided. However, they are also aware that failure to make recommendations leaves their people subject to the wide variability in product quality.
“Organizations are now looking to make more deliberate moves toward recommendation. It is our view that only those companies who raise the bar in quality, safety, and efficacy with sound, transparent practices will be up to the standards required for such opportunities. Our research with Mayo Clinic addresses the rigors commensurate with this growing scale of opportunity and responsibility.”