Actively Recruiting
A Precision Nutrition Approach to Enhancing Physical Function in Older Adults: A Pilot, Feasibility Study
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17
25
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the effects of beta-hydroxy-methylbutyrate (HMB) supplementation on physical function in older adults aged 65 to 85 years. This pilot, single-arm study lasting 12 weeks aims to assess how feasible and acceptable the intervention and study procedures are. The study also evaluates changes in physical function and explores multi-omics patterns to describe physical function phenotypes in this population. Participants will take HMB with vitamin D3 capsules twice daily for 12 weeks. If a participant's vitamin D3 levels are above 80 ng/dL, they will receive HMB capsules without vitamin D3 instead. The intervention is designed to be flexible based on vitamin D3 levels and will be provided after initial screening and testing. During the study, participants will undergo various assessments including physical function tests (such as sit-to-stand, grip strength, gait speed, and 400-meter walk), cognitive tests, dietary assessments, and imaging scans (MRI and ultrasound). Blood and stool samples will be collected to analyze metabolomic and inflammatory markers. The study will monitor safety, attendance, and adherence, with outcome measurements taken at baseline, 6 weeks, and 12 weeks. The total study period extends about one year for screening and data collection following the 12-week intervention.
CONDITIONS
Brief 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
- Diagnosed with one or more chronic medical conditions based on Medicare's 21 multiple chronic conditions list (such as arthritis, asthma, cancer, diabetes, heart failure, hypertension, and others)
You will not qualify if you...
- Younger than 65 or older than 85 years
- Diagnosed with dementia
- Negative for subjective weakness screening (score less than 1)
- Life-threatening or untreated psychiatric illness requiring significant care changes (e.g., severe depression, substance abuse, schizophrenia, bipolar disorder)
- Life-threatening illness including those receiving palliative or hospice care
- Unable or unwilling to provide consent
- Unable to complete study procedures
- Scheduled for elective surgery within the next four months
- Using antiobesity medications that cause weight loss
- Hospitalized for heart failure in the past 6 months
- Advanced non-skin cancer (stage III or IV) under treatment
- Advanced liver failure
- Chronic renal insufficiency requiring hemodialysis
- Advanced chronic obstructive pulmonary disease preventing participation
- Vitamin D levels above 80 ng/dL without available vitamin D-free supplement formulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take beta-hydroxymethyl butyrate supplements with or without vitamin D3 depending on their vitamin D levels for 12 weeks.
Visits at baseline, 6 weeks, and 12 weeks
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
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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