Precision Medicine and Physical Function

Summary

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)

Conditions

• Frailty
• Weakness, Muscle
• Multiple Chronic Conditions

Interventions

DIETARY_SUPPLEMENT

Beta-hydroxymethyl butyrate supplement

Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)

DIETARY_SUPPLEMENT

Vitamin D supplement

Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)

DIETARY_SUPPLEMENT

Matching Beta-hydroxymethyl butyrate supplement without Vitamin D

Beta-hydroxymethyl butyrate (750 mg) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate per capsule. Frequency is 2 capsules twice daily (morning, evening)

Sponsors & Collaborators

• North Carolina Translational and Clinical Sciences Institute

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• John Batsis, MD, AGSF · University of North Carolina, Chapel Hill

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2026-12-01

Completion

2026-12-01

Countries

• United States

Study Locations