(P23-071-23) BB-Health: A Pilot Randomized Feasibility Trial of Food Supplement and Behavioral Weight Management Interventions To Prevent Cognitive Decline in Older Adults

Objectives: Older adults with obesity have an increased risk for cognitive decline and Alzheimer’s disease. Previous research has focused on the impact of individual nutrients and overall dietary patterns to improve cognitive function. The Brain and Body Health (BB-Health) study aims to demonstrate the feasibility of recruiting participants for a randomized trial for multicomponent nutritional supplement (MCNS) and weight loss (WL) interventions.

Methods: BB-Health is a parallel-group randomized placebo-controlled 2x2 factorial trial comparing the MCNS, WL, and MCNS+WL with a Control group. The outcomes of interest are cognition, cerebral hemodynamics, and related health variables. Eligible participants are 55 to 85 years of age with a body mass index greater than 27.99 kg/m². Major exclusion criteria include type II diabetes, moderate or severe cognitive impairment, and consumption of a healthy dietary pattern. Participants are randomized after baseline measurements with scheduled assessment visits at three, six, and 12 months. All enrolled participants attend weekly MCNS adherence meetings by videoconference, and daily MCNS consumption logs are also completed. The BB-Health feasibility trial is registered as NCT05542199.

Results: 17 participants were enrolled in BB-Health during a 3-month period in 2022 (53% male, 53% from underrepresented groups), with a mean age of 67 years (range: 57 to 80). Based on observed and reported consumption, adherence to the MCNS is 98% to date. For the subset of participants randomized to WL, attendance during group meetings is also 98%. No participant dropped out or was withdrawn, and no serious adverse events have been reported.

Conclusions: These initial results demonstrate the feasibility of recruiting older adults with overweight and obesity for a trial combining MCNS and WL interventions.

Funding Sources: NIH R56AG065236; USDA Agricultural Research Service under Cooperative Agreement No. 58-1950-7-707