University of North Carolina, Chapel Hill
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)
Frailty
Weakness, Muscle
Multiple Chronic Conditions
Beta-hydroxymethyl butyrate supplement
Vitamin D supplement
Matching Beta-hydroxymethyl butyrate supplement without Vitamin D
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 25 participants |
Masking : | None (Open Label) |
Primary Purpose : | Other |
Official Title : | A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study |
Actual Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | June 1, 2024 |
Estimated Study Completion Date : | June 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Participants with Weakness Participants will take beta-hydroxymethyl butyrate (HMB) with vitamin D3 for 12 weeks. Those participants with vitamin D3 levels > 80 ng/dL will be provided intervention capsules without vitamin D3. |
Dietary Supplement: Beta-hydroxymethyl butyrate supplement Dietary Supplement: Vitamin D supplement Dietary Supplement: Matching Beta-hydroxymethyl butyrate supplement without Vitamin D |
Ages Eligible for Study: | 65 Years to 85 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599