Long-term Effects of Two Plant-based Dietary Supplements on Low-grade Inflammation, Cardiovascular Disease Prevention and Indicators of Biological Aging (P06-080-19)

OBJECTIVES: Low- grade inflammation is a pathological feature of a wide range of chronic conditions, including the metabolic syndrome, cardiovascular diseases (CVD)(1, 2) and the accelerated reduction in bone density(3). Previous research shows that diets rich in fruits and vegetables can reduce chronic inflammation(4, 5). To date there is no data on multiyear clinical interventions assessing the effect of plant-based dietary supplements on low-grade inflammation, cardiovascular disease prevention and indicators of biological aging. To assess the long-term effect of two plant based macro- and micronutrient food supplements on low-grade inflammation, cardiovascular disease prevention and indicators of biological ageing in overweight, elderly people. METHODS: This is a 3-arm open labelled, balanced, parallel design, observational study assessing the effectiveness of two different supplements vs control. Ninety overweight and obese volunteers, aged 50–80 years, will be recruited and followed up for the duration of 2 years. Since this is a long term trial and in order to maximize adherence to interventions, we will allow volunteers to choose their preferred treatment and we will implement a propensity score design. More specifically, for each participant an individual score based on certain parameters will be calculated (Table 1) and will be matched with another participant with the same propensity score across the three groups, exerting a ‘post-randomization’ effect. Multiple primary endpoints will be changes in markers of low-grade inflammation, CVD risk and micronutrients status (Table 2). Secondary outcomes will include assessment of Upper Respiratory Tract Symptoms, Gastrointestinal Symptoms, Quality of Life and Anthropometry. Furthermore, Cognitive Function, Bone quality and Leucocyte Telomere length will be assessed as tertiary outcomes. RESULTS: n/a CONCLUSIONS: This study will provide data on the effect of long-term, plant-based supplementation on chronic conditions and nutritional status in aging. In addition, the novel study design implemented might counteract the high dropout rate often observed in long term nutritional interventions and might create a new era with regards to study design approach in the field of nutritional science. FUNDING SOURCES: The Juice Plus+ Science Institute received funding by The Juice Plus+® Company for this project. SUPPORTING TABLES, IMAGES AND/OR GRAPHS