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Precision Medicine and Physical Function Study

This study is looking at how a dietary supplement called Beta-hydroxy-methylbutyrate (HMB), with or without Vitamin D3, affects physical function in older adults. You might be able to join if you are between 65 and 85 years old, speak English, and are a patient at the UNC Geriatrics Medicine clinic with multiple chronic conditions. The researchers want to see if the supplement is safe and easy to use, and how it might improve physical abilities. They are also looking at how many people sign up and complete the study. This study plans to enroll 25 participants.

Study design
This is a 12-week study where all 25 participants will receive the intervention (single-arm).
What's involved
You would take two capsules of the supplement twice daily (morning and evening) for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Information will be collected on each participant at the conclusion of the 12-week study intervention, and through the end of the study period (approximately one year).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05877846

Precision Medicine and Physical Function

Recruiting
NAAges 65–85Interventional
University of North Carolina, Chapel Hill
~25 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Beta-hydroxymethyl butyrate supplementVitamin D supplementMatching Beta-hydroxymethyl butyrate supplement without Vitamin D

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Enrolled
Measured over at 12-weeks
+11 more outcomes measured

Conditions

Frailty
Weakness, Muscle
Multiple Chronic Conditions

Explore related trials

FrailtyMultiple chronic diseasesMuscle Weakness

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • John Batsis, MD, AGSF · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Danae C Gross, MS
[email protected]
(919)445-6776
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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
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.

What this trial measures

  • Percentage of Participants Enrolledat 12-weeks

    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.

  • Number of Participants ScreenedThrough the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).

    Feasibility of study procedures as measured by the number of participants that were screened.

  • Percentage of participants consentedThrough the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).

    The percent of participants that consented in the study is defined as the number of participants that were consented divided by the # of participants screened multiplied by 100. There are no cut-off scores for interpretation but, higher scores indicate greater feasibility of the study.

  • Percent attendanceThrough the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).

    Feasibility of study procedures measured as the mean attendance rate of all participants. Participant attendance rate = (total # of visits attended / total # of visits scheduled) x 100. There are no cut-off scores for interpretation. Higher scores indicate higher feasibility

  • Percent of Interviews completedThrough the end of the study period (~1 year) based on data collected on each participant at the conclusion of the study intervention (12-weeks).

    Feasibility of study procedures measures as interview completion rate. Percent of completed interviews = (# of completed interviews / # of participants completing the intervention) x 100. There are no cut-off scores for interpretation. Higher rates are indicative of higher feasibility.

  • Percentage of study measures collected12 weeks after baseline visit

    Rate of the percent of study measures collected, defined as the # of study procedures collected divided by the total # of proposed study procedures x 100. A higher number is characteristic of increased feasibility of collecting study measures.

  • Percent of participants conducted MRI measure12 weeks after baseline visit

    Rate of participants who conducted two MRI measures, defined as the total number of MRI measures collected divided by the total expected number of MRI measures. A higher number indicates feasibility of obtaining MRI measures.

  • Percent of participants conducted ultrasound measure12 weeks after baseline visit

    Rate of participants who conducted three ultrasound measures, defined as the total number of MRI measures collected divided by the total expected number of ultrasound measures. A higher number indicates feasibility of obtaining ultrasound measures.

  • Acceptability of study intervention12 weeks after baseline visit

    Measured through an end of study satisfaction survey, acceptability is measured on a 10 point Likert scale conducted on all participants at 12-weeks. This is rated on a 1 (strongly disagree) to 10 (strongly agree) survey.

  • Percent of Participants Rating the Intervention as Acceptable12 weeks after baseline visit

    Conducted on all participants using a 1-5 Likert scale to assess appropriateness of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Acceptability is reported as Agree or Completely Agree responses. Rate is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.

  • Percent of participants rating the intervention as appropriate12 weeks after baseline visit

    Conducted on all participants using a 1-5 Likert scale to assess appropriateness of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Intervention appropriateness is reported as Agree or Completely Agree responses. Rate is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.

  • Percent of participants rating the intervention as feasible12 weeks after baseline visit

    Conducted on all participants using a 1-5 Likert scale to assess feasibility of the study intervention measures using the following: completely disagree, disagree, neither agree or disagree, agree, completely agree. Intervention feasibility is reported as Agree or Completely Agree responses. Rate is calculated as total number of participants rating as agree or complete agree divided by the number of total participants.