HMB Plus Vitamin D to Help Keep Muscle in Older Adults Starting Semaglutide
Tests HMB plus vitamin D for muscle loss in older adults with diabetes starting semaglutide.
Plain-language title generated from the registry record
Registry title: HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
Key facts
- Where
- Nashville, United StatesSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 65 to 85 with type 2 diabetes who are newly starting semaglutide as part of usual care. It tests a muscle supplement (calcium-HMB plus vitamin D3) against a placebo.
- Age
- 65 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes (HbA1c at or above 6.5% (48 mmol/mol) or current use of diabetes medicine) with a body mass index at or above 27 kg/m2. Must be able to walk 400 meters without help; a cane is allowed.
- Earlier treatment
- Must be newly starting semaglutide as standard clinical care. Cannot have used HMB, creatine or high-dose whey protein supplements in the previous 3 months.
- Biomarker or test result
- Serum 25-hydroxyvitamin D must not be below 15 ng/mL. Estimated glomerular filtration rate (kidney function) must not be below 45 mL/min/1.73 m2.
Main reasons for not taking part
- Weight change of more than 5% in the previous 3 months
- Fracture in the previous 6 months
- Neuromuscular disease, including Parkinson disease
- Chronic corticosteroid use
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or a history of pancreatitis
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 65 and 85 years old?
Source: NCT07760948, who can take part
Where in United States
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vanderbilt University Medical Center
- Trial code
- NCT07760948
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
Preserving the Metabolic Engine: Effects of HMB Supplementation on Skeletal Muscle Structure and Function During Semaglutide-Associated Weight Loss in Older Adults
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.
Inclusion: 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: 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; 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; 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; Estimated glomerular filtration rate below 45 mL/min/1.73 m2; Smoking more than 7 cigarettes per day; Pregnancy or breastfeeding.