Precision Medicine and Physical Function

NCT05877846 | Recruiting

• 1 other identifier: 23-0141
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants Enrolled

  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.

  at 12-weeks

• Number of Participants Screened

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

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

• Percentage of participants consented

  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.

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

• Percent attendance

  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

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

• Percent of Interviews completed

  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.

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

• Percentage of study measures collected

  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.

  12 weeks after baseline visit

• Percent of participants conducted MRI measure

  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.

  12 weeks after baseline visit

• Percent of participants conducted ultrasound measure

  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.

  12 weeks after baseline visit

• Acceptability of study intervention

  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.

  12 weeks after baseline visit

• Percent of Participants Rating the Intervention as Acceptable

  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.

  12 weeks after baseline visit

• Percent of participants rating the intervention as appropriate

  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.

  12 weeks after baseline visit

• Percent of participants rating the intervention as feasible

  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.

  12 weeks after baseline visit

Secondary Outcomes (43)

• Change in weight from baseline

  At baseline, 6 weeks, and 12 weeks

• Change in waist circumference from baseline

  At baseline, 6 weeks, and 12 weeks

• Change in hip circumference from baseline

  At baseline, 6 weeks, and 12 weeks

• Change in arm circumference from baseline

  At baseline, 6 weeks, and 12 weeks

• Change in calf circumference from baseline

  At baseline, 6 weeks, and 12 weeks

Other Outcomes (10)

• Change in interleukin 5 (IL-5) blood levels from baseline

  At baseline and 12 weeks

• Change in interleukin 13 (IL-13) blood levels from baseline

  At baseline and 12 weeks

• Change in interleukin 2 (IL-2) blood levels from baseline

  At baseline and 12 weeks

Study Arms (1)

Participants with Weakness

EXPERIMENTAL

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.

Dietary Supplement: Beta-hydroxymethyl butyrate supplement; Dietary Supplement: Vitamin D supplement; Dietary Supplement: Matching Beta-hydroxymethyl butyrate supplement without Vitamin D

Interventions

Matching Beta-hydroxymethyl butyrate supplement without Vitamin D 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)

Participants with Weakness

Beta-hydroxymethyl butyrate supplement 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)

Participants with Weakness

Vitamin D supplement 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)

Participants with Weakness

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Muscle Weakness; Multiple Chronic Conditions

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• John Batsis, MD, AGSF

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danae C Gross, MS

CONTACT

(919)445-6776; dcgross@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study is a 12-week, single arm, pre/post intervention of β-hydroxymethyl butyrate (HMB) in n=18 older adults at risk for sarcopenia. There will be no randomization.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 26, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)