Actively Recruiting
Precision Medicine and Physical Function
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17
25
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
N
North Carolina Translational and Clinical Sciences Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Precision Medicine and Physical Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking adults aged 65 to 85 years
- Patients of the University of North Carolina at Chapel Hill Geriatrics Medicine clinic
- Have one or more chronic medical conditions from the Medicare list of 21 multiple chronic conditions (e.g., arthritis, asthma, diabetes, heart disease, depression)
You will not qualify if you...
- Younger than 65 years or older than 85 years
- Diagnosis of dementia
- Negative subjective weakness screening score (less than 1)
- Life-threatening or untreated psychiatric conditions that interfere with participation (e.g., major depression, substance abuse, suicidal thoughts, severe mental illness)
- Life-threatening illness including those receiving palliative care or hospice
- Unwilling or unable to provide consent
- Unable to complete study procedures
- Scheduled elective surgery in next four months
- Use of antiobesity medications that cause weight loss
- Hospitalization for heart failure in past 6 months
- Advanced non-skin cancer (Stage III or IV) under treatment
- Advanced liver failure
- Chronic kidney failure requiring hemodialysis
- Advanced chronic obstructive pulmonary disease preventing participation
- Vitamin D level above 80 ng/dL at baseline (participants with high vitamin D may be excluded or offered HMB without vitamin D)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
D
Danae C Gross, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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