Muscle-Saving supplement may shield seniors from Weight-Loss drug side effect
NCT ID NCT07760948
First seen Aug 12, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This trial tests whether a daily supplement of calcium-HMB plus vitamin D3 can help adults aged 65 to 85 with type 2 diabetes keep their muscle mass and metabolism while starting semaglutide, a common weight-loss and diabetes medication. Participants take the supplement or a placebo for about 6 months. Researchers measure changes in muscle mass, strength, physical function, and resting metabolism to see if the supplement counters the muscle loss that can accompany semaglutide use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- calcium-HMB (beta-hydroxy-beta-methylbutyrate) plus vitamin D3
- What this could lead to
- If effective, this supplement could help older adults on semaglutide lose fat while keeping muscle and metabolic health, improving physical function and quality of life.
- What could go wrong
- This is a small, early-stage trial. The supplement may not prevent muscle loss, and results may not apply to all older adults. Side effects are possible but generally mild.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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