Session 8 – Bioactive Compounds: Safety, Benefits, and Evidence-Based Guidance

Marissa Kuehn, MS, RDN, Amway, USA

Marissa Kuehn is a Registered Dietitian Nutritionist who has worked in the food and supplement industry since 2014, with a focus in global regulatory and scientific affairs. She provides critical insights and interpretations of current, pending, and future international product regulations and safety requirements to cross-functional teams. Marissa is an alumni of California Polytechnic State University, San Luis Obispo holding a Bachelor of Science in Applied Nutrition. She has also earned a Master of Science in Nutrition Sciences from California State University, Long Beach. Marissa is a strong advocate for helping people take control of their health through evidence-based practice.

Intake Guidance for Bioactives: Expanding the Food-Based Framework to Dietary Supplements – Janet Novotny, PhD, USDA, USA

Abstract: While consumers have access to ample information about the amounts of essential nutrients that are required for health, there is limited quantitative guidance on safe and efficacious amounts of non-essential bioactive compounds to achieve certain metabolic and health related effects, making it difficult for consumers to make informed choices. The existing framework for establishing intake guidance for food bioactives has proven successful, as evidenced by the recent intake guideline for food-based flavan-3-ols. However, the food-based framework did not take into account special considerations for dietary supplements. As part of a recent ILSI US and Canada initiative, the framework has been expanded to provide a pathway to evaluate, synthesize, and interpret data related to dietary supplement bioactives for evidence-based recommendations. The expanded framework can serve as a resource for industry to develop best practices, for researchers to design the highest quality studies, and for healthcare professionals to develop recommendations for use of dietary supplement-containing bioactives.

Janet A. Novotny is a Research Physiologist with the USDA’s Beltsville Human Nutrition Research Center, where she conducts clinical nutrition studies and directs a chromatography and mass spectrometry analytical lab. Holding degrees in mathematics, nutrition, and biophysics, Dr. Novotny combines her areas of expertise to conduct studies on diet, pharmacokinetics, and health and serves as an advisor to USDA’s FoodData Central. Dr. Novotny’s research has encompassed a wide range of nutrients and bioactives, including carotenoids; anthocyanins; glucosinolates and isothiocyanates; vitamins A, E, K, and D; and molybdenum. Dr. Novotny is active in the American Society for Nutrition, is a member of the International Life Sciences Institute US & Canada Committee on Bioactives, and has served as an external advisor on bioactives for the Department of Defense and multiple commodity and industry groups.

Case Study: Establishing Dietary Guidance for Lutein – Elizabeth Johnson, PhD, Friedman School of Nutrition Science and Policy, Tufts University, USA

Abstract: It has been 11 years since Lupton et al. (Eur J Nutr, 2014) proposed criteria for a bioactive to qualify for evaluation for dietary guidance. These criteria are: 1) a commonly used definition for the bioactive; 2) a method for analyzing the bioactive which is consistent with the definition; 3) a database for the amount of the bioactive in foods; 4) prospective cohort studies on health outcomes; 5) clinical trials on digestion, absorption, activation, transport, excretion; 6) clinical trials on efficacy and dose response; 7) safety data at the level of intake; 8) systematic reviews/meta-analyses on efficacy; and 9).a plausible biological explanation for efficacy. An evaluation of lutein using these criteria warrants consideration for guidance on intake.

Elizabeth J. Johnson, Ph.D. obtained her Ph.D. in nutritional biochemistry at the University of Wisconsin-Madison. Her postdoctoral work was conducted at the Jean Mayer USDA Human Nutrition Center on Aging at Tufts University where she began clinical studies on research on human metabolism of carotenoids. She currently has a faculty appointment at the Friedman School of Nutrition Science & Policy at Tufts University. She has over 35 years of experience in the study of nutrition and healthy aging with an emphasis on carotenoids and age-related visual and cognitive function and has over 100 peer-reviewed publications of which more than sixty are on the topic of carotenoids. She is a member of the International Carotenoid Society. Other memberships include the American College of Nutrition, Carotenoid Research Interactive Group, American Society for Nutrition, and the Brain and Ocular Nutrition Group. Dr. Johnson also has editorial roles at The Journal of Nutrition, Nutrients and Journal of Nutrition in Gerontology and Geriatrics.

Bioactives in Dietary Supplements: An Industry Perspective – Andrew Shao, PhD, Niagen Bioscience, USA

Abstract: Bioactives are substances derived from plants or animals, that when included in the diet confer a health benefit to the host. Unlike essential vitamins and minerals, whose long-established benefit is based primarily on the avoidance of overt nutrient deficiency, bioactives are considered non-essential. Rather than avoidance of nutrient deficiency the benefits derived from inclusion of bioactives in the diet pertain more to health promotion, improved healthspan or resilience. Indeed, the field of nutrition has itself evolved in developed countries as a means to promote health rather than avoid deficiency. Dietary supplements have and will continue to serve as a significant source of the population’s intake of bioactives. However, despite a plethora of research advances around the benefits of supplementation with bioactives, how these substances are commercialized in dietary supplements is not well understood by investigators and practitioners. Understanding the main aspects and considerations for bioactive product development can help inform research, reporting and practitioner recommendations.

Andrew Shao, Ph.D., joined ChromaDex, Inc. in 2019 where he currently serves as SVP, Global Regulatory & Scientific Affairs, and is responsible for overseeing the company’s research and development, scientific affairs, regulatory affairs and quality functions.

Dr. Shao has spent over 25 years in the global nutrition industry, assuming leadership roles in various nutrition, scientific, regulatory and government affairs functions. Prior to joining Niagen Bioscience Dr. Shao held several leadership positions at Herbalife Nutrition, and served as Sr. VP Scientific & Regulatory Affairs for the Washington, DC-based trade association, the Council for Responsible Nutrition (CRN). Before joining CRN, he was a senior scientist at General Nutrition Corporation (GNC), and previously, in research and development at Kemin.

Dr. Shao is the author or co-author of over 60 peer-reviewed articles, abstracts, trade articles and book chapters and serves on the Editorial Board of several peer-reviewed journals. He is a past Chair of the Sustaining Partners Roundtable of the American Society for Nutrition, currently serves as Chair of the ASN Publications Committee and is member of the Tufts Nutrition Council.

Dr. Shao holds a doctorate in nutritional biochemistry and master’s in human nutrition science, both from Tufts University, and a bachelor’s in biology from Brandeis University.