NCT05877846 Precision Medicine and Physical Function
| NCT ID | NCT05877846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Frailty |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2023-11-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
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.
Contact & Investigator
John Batsis, MD, AGSF
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT05877846 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05877846 currently recruiting?
Yes, NCT05877846 is actively recruiting participants. Contact the research team at dcgross@unc.edu for enrollment information.
Where is the NCT05877846 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT05877846 clinical trial?
NCT05877846 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is John Batsis, MD, AGSF at University of North Carolina, Chapel Hill. The trial plans to enroll 25 participants.