Early access
Sign in
Not yet taking people in United StatesPhase 2

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.

Key facts

Who runs it
Vanderbilt University Medical Center
Where
Nashville, United StatesSee the site
Trial code
Registry title
HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
Status
Not yet recruiting
Phase
Phase 2
People taking part
90 people, planned
Starts
1 Dec 2026
Expected to end
Nov 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Calcium-HMB Plus Vitamin D3
  • Matching placebo
Record updated
28 August 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in United States

  • Vanderbilt University Medical CenterNashville, United StatesContact: Robb Flynn, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Calcium-HMB Plus Vitamin D3Treatment being tested

    Participants receive active calcium-HMB plus vitamin D3 for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.

  • Matching PlaceboPlacebo, for comparison

    Participants receive matching placebo for approximately 6 months while semaglutide is prescribed and managed as standard clinical care.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Preserving the Metabolic Engine: Effects of HMB Supplementation on Skeletal Muscle Structure and Function During Semaglutide-Associated Weight Loss in Older Adults
Plain-language title
HMB Plus Vitamin D to Help Keep Muscle in Older Adults Starting SemaglutideGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07760948, who can take part
Record updated
28 August 2026