NCT05877846 · University of North Carolina, Chapel Hill
Precision Medicine and Physical Function
(HMB)
What this study is about
The investigators aim to conduct a 12-week, single-treatment group$1, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- English-speaking older adults aged 65 to 85 years (of all genders and sexes, race or ethnicity)
- A University of North Carolina at Chapel Hill (UNC) Geriatrics Medicine clinic patient;
- Chronic medical conditions -these are based on the 21 Medicare multiple chronic conditions (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal, lung, prostate), chronic kidney disease, chronic obstructive pulmonary disease, depression, diabetes, drug/substance abuse, heart failure, hepatitis, HIV/AIDS, hyperlipidemia, hypertension, ischemic heart disease, osteoporosis, schizophrenia/other psychotic disorders, stroke);
Exclusion criteria
- Age \<65 years and \>85 years old
- A medical diagnosis of dementia
- Those without a negative subjective weakness screener (\<1)
- Individuals with life-threatening or untreated psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as untreated major depressive disorder, substance abuse, suicidal ideation or untreated severe mental illness (schizophrenia, bipolar disorder)
- Life-threatening illness including those receiving palliative care or hospice services
- Individuals unwilling/unable to provide consent
- Inability to complete the protocol procedures
- Elective surgery in the next four months
- Medications - antiobesity (weight loss agents) medications that lead to weight loss
- Hospitalization for heart failure in past 6 months, advanced non-skin cancer (Stage III or IV) on treatment; Advanced liver failure; Chronic renal insufficiency on hemodialysis; advanced Chronic obstructive pulmonary disease (COPD) that would prevent engagement \*\*\*Vitamin D \>80 ng/dL:
- At baseline, the investigators will check Vit D levels - recognize that processing is highly dependent on the McLendon lab and may take up to 7+ days to come back.
- Concurrently, the investigators will consider continuing consent, enrollment, study procedures.
- Provide at Visit 2 the beta-hydroxymethyl butyrate/Vitamin D supplement
- Once the results have been received and reviewed - if the levels exceed 80 ng/dL, then the participant will be informed.
- At that point, the investigators will either exclude the participant or, if available, see whether the company is willing to provide formulations of just beta-hydroxymethyl butyrate (HMB)and provide this to the participant
- These guidelines account for the fact that Vit D is not recommended by American Geriatrics Society to check routinely, and that levels \<80 (or even 120 ng/mL) rarely lead to toxicity.
Where
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations