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A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study
The investigators aim to conduct a 12-week, single-arm, pre/post-intervention of b-hydroxy-methylbutyrate in persons aged 65 to 85 years to assess feasibility and acceptability of the intervention and study procedures, secondary outcomes of physical function and changes in multi-omics patterns, and exploratory outcomes that will allow the team to describe physical function phenotype. The investigators' primary outcomes are the: feasibility of the study procedures (including safety), feasibility of the intervention delivery, and acceptability of study procedures and measures. Secondary outcomes include: Objective and subjective physical function measures that predict disability including the 30-second sit-to-stand, knee strength, isokinetic strength, grip strength, gait speed, 400-m walk test, Pittsburgh Fatiguability, PROMIS global health-10, social support, anthropometry, National Institutes of Health (NIH) Cognitive toolbox, Automated Self-Administered 24-hour Dietary Assessment (ASA-24), Community Healthy Activities Model Programs (CHAMPS), Ultrasound Imaging, Magnetic Resonance Imaging (MRI), Changes in untargeted metabolomic profile data based on qualitative or semiquantitative analysis of the most probable detectable metabolites in laboratory samples , Discover potential metabolites that explain changes in physical function using a discovery science, precision medicine approach (discovery science approach that is exploratory)
Age
65 - 85 years
Sex
ALL
Healthy Volunteers
No
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Start Date
November 1, 2023
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
February 17, 2026
25
ESTIMATED participants
Beta-hydroxymethyl butyrate supplement
DIETARY_SUPPLEMENT
Vitamin D supplement
DIETARY_SUPPLEMENT
Matching Beta-hydroxymethyl butyrate supplement without Vitamin D
DIETARY_SUPPLEMENT
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
NCT07469761
NCT06820021
Data Source & Attribution
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