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NOT YET RECRUITING
NCT07760948
PHASE2

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

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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.

OTHER

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