Can a tailored supplement boost strength in seniors? new study aims to find out
NCT ID NCT05877846
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a 12-week personalized nutrition supplement (beta-hydroxy-methylbutyrate) can improve physical function in adults aged 65-85 with frailty and multiple chronic conditions. The main goal is to see if the study procedures are feasible and acceptable to participants. Researchers will also measure changes in strength, mobility, and overall health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of North Carolina at Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27599, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a frailty score predict which older cancer patients survive intensive care?
- Can Pre-Surgery training help frail hearts recover?
- Can spotting frailty make endoscopy safer for older adults?