Clinical trial

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

Opening soon · Phase 2 · 1 countries · Registry ID NCT07760948

Opening soonPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age65 Years to 85 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes Mellitus (T2DM), Sarcopenia, Obesity, Muscle Loss, Older Adults

Full registry criteria

Inclusion Criteria: * Age 65 to 85 years, inclusive. * Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication. * Body mass index at or above 27 kg/m2. * Newly initiating semaglutide as standard clinical care under the direction of a treating clinician. * Able to walk 400 meters without assistance; use of a cane is permitted. * Able to understand and provide legally effective informed consent. * English speaking for the initial study because the consent documents, questionnaires, study-product instructions, safety instructions, and procedure-specific materials are available only in English. Exclusion Criteria: * Estimated glomerular filtration rate below 45 mL/min/1.73 m2. * Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months. * Weight change greater than 5% during the previous 3 months. * Recent fracture within the previous 6 months. * Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation. * Chronic corticosteroid use. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. * History of pancreatitis. * Smoking more than 7 cigarettes per day. * Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome. * Pregnancy or breastfeeding. * Recent history of neoplasia within the previous 5 years, as defined by the protocol. * Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety. * Serum 25-hydroxyvitamin D below 15 ng/mL. * Any medical, functional, laboratory, medication-related, or safety condition that the investigator determines makes study participation unsafe or prevents completion of essential procedures.

Treatments and study arms

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.

Primary outcomes

Change in Appendicular Lean MassBaseline to month 6

Appendicular lean mass will be measured by whole-body dual-energy X-ray absorptiometry. The outcome is the month-6 value minus the baseline value, reported in kilograms.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Vanderbilt University Medical Center🇺🇸 Nashville, Tennessee, United States