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NCT05877846 · ClinicalTrials.gov registry record · NA
Precision Medicine and Physical Function
A NA study of Frailty and Multiple Chronic Conditions, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05877846: Recruiting NA study of Frailty and Multiple Chronic Conditions, sponsored by University of North Carolina, Chapel Hill.
NCT05877846 is a NA study of Frailty and Multiple Chronic Conditions that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants, below the 1,506-participant average among 48 other Frailty trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05877846, a NA study of Frailty and Multiple Chronic Conditions, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
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)
Primary Outcome
Feasibility of study procedures is measured by the percentage of enrolled participants that were screened (percent participants enrolled = number of participants enrolled/number of participants screened x 100). There are no cut-off scores for interpretation but, higher scores indicate greater feasibility of the study.
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 |
What NCT05877846 shows while recruiting
NCT05877846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,506-participant average among 48 other Frailty trials with a reported enrollment target (98% lower).
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.
NCT05877846 reports a single indexed study location in North Carolina.
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.
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).
Who is sponsoring clinical trial NCT05877846?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05877846's enrollment target sits among peer trials
25 41st of 48 higher than 8 of 48 other Frailty trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Frailty trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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