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HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
Sponsor: Vanderbilt University Medical Center
Summary
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.
Official title: Preserving the Metabolic Engine: HMB Supplementation to Combat Iatrogenic Sarcopenia and Metabolic Adaptation in Older Adults Initiating Semaglutide Therapy
Key Details
Gender
All
Age Range
65 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-12-01
Completion Date
2030-11
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
Calcium-HMB Plus Vitamin D3
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
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.
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States