HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07760948
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Muscle Loss
  • Obesity
  • Older Adults
  • Sarcopenia
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Calcium-HMB Plus Vitamin D3 — DIETARY_SUPPLEMENT
    Each active capsule contains 750 mg calcium-HMB and 200 IU vitamin D3. Participants take two capsules twice daily, providing 3 g calcium-HMB and 800 IU vitamin D3 per day, for approximately 6 months.
  • Matching placebo — OTHER
    Participants take two matching placebo capsules twice daily for approximately 6 months. Placebo capsules are matched to active product in appearance, packaging, labeling, and dosing schedule. Insert the final placebo ingredients if the PRS administrator requests them.

Study Details

This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.

Key Dates

First listed
Aug 12, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Calcium-HMB Plus Vitamin D3
    Participants receive active calcium-HMB plus vitamin D3 for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.
  • Placebo Comparator: Matching Placebo
    Participants receive matching placebo for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.

Primary Outcome Measure

Change in Appendicular Lean Mass [ Time Frame: Baseline to month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

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By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Vanderbilt University Medical Center· Nashville, TN

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