Precision Medicine and Physical Function

NCT ID: NCT05877846

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-12-01

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)

Conditions

Frailty; Weakness, Muscle; Multiple Chronic Conditions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Participants with Weakness

Participants will take beta-hydroxymethyl butyrate (HMB) with vitamin D3 for 12 weeks. Those participants with vitamin D3 levels \> 80 ng/dL will be provided intervention capsules without vitamin D3.

Group Type: EXPERIMENTAL

Beta-hydroxymethyl butyrate supplement

Intervention Type: DIETARY_SUPPLEMENT

Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)

Matching Beta-hydroxymethyl butyrate supplement without Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Beta-hydroxymethyl butyrate (750 mg) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate per capsule. Frequency is 2 capsules twice daily (morning, evening)

Interventions

Beta-hydroxymethyl butyrate supplement

Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D supplement

Beta-hydroxymethyl butyrate (750 mg) - Vitamin D3 (200 IU) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate with 200 IU of vitamin D3 per capsule. Frequency is 2 capsules twice daily (morning, evening)

Intervention Type: DIETARY_SUPPLEMENT

Matching Beta-hydroxymethyl butyrate supplement without Vitamin D

Beta-hydroxymethyl butyrate (750 mg) capsules. The formulation is 750 mg of Beta-hydroxymethyl butyrate per capsule. Frequency is 2 capsules twice daily (morning, evening)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Batsis, MD, AGSF

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Danae C Gross, MS

Role: CONTACT

dcgross@unc.edu

(919)445-6776

Facility Contacts

Danae C Gross, MS

Role: primary

dcgross@unc.edu

919-445-6776

June Weston

Role: backup

jweston9@email.unc.edu

Other Identifiers

23-0141

Identifier Type: -

Identifier Source: org_study_id