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Precision Medicine and Physical Function
NCT05877846 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DIETARY_SUPPLEMENT Beta-hydroxymethyl butyrate supplement
- DIETARY_SUPPLEMENT Vitamin D supplement
- DIETARY_SUPPLEMENT Matching Beta-hydroxymethyl butyrate supplement without Vitamin D
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2026-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05877846
The ClinicalTrials.gov registry entry for NCT05877846 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Frailty appearing as the primary indexed condition, and to 3 interventions — of which Beta-hydroxymethyl butyrate supplement is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05877846 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05877846 about?
NCT05877846 is a clinical study titled "Precision Medicine and Physical Function". 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 ...
What is the current status of trial NCT05877846?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2023-11-01. Estimated completion is 2026-12-01.
What conditions does trial NCT05877846 study?
This clinical trial studies the following conditions: Frailty, Multiple Chronic Conditions, Weakness, Muscle. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05877846?
The interventions under investigation include: Beta-hydroxymethyl butyrate supplement (DIETARY_SUPPLEMENT), Vitamin D supplement (DIETARY_SUPPLEMENT), Matching Beta-hydroxymethyl butyrate supplement without Vitamin D (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05877846?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05877846 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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