NCT07760948Not yet recruitingPhase 2
HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
Preserving the Metabolic Engine: Effects of HMB Supplementation on Skeletal Muscle Structure and Function During Semaglutide-Associated Weight Loss in Older Adults
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Nov 2029
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07760948
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 1 Dec 2026 to the primary completion date, 30 Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Chronic corticosteroid use.
- Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome.
- Recent history of neoplasia within the previous 5 years, as defined by the protocol.
Other illness
- Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
- History of pancreatitis.
- Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety.
Lab values
- 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.
Other
- Estimated glomerular filtration rate below 45 mL/min/1.73 m2.
- Smoking more than 7 cigarettes per day.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 65 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.