HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-85
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Calcium-HMB Plus Vitamin D3
Dietary supplementEach 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 interventionParticipants 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Calcium-HMB Plus Vitamin D3Experimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Appendicular Lean Mass
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.
Time frame
Baseline to month 6Secondary outcomes
1
Title Change in Body Weight
Body weight measured using a calibrated scale; change calculated as month 6 minus baseline, in kilograms.
Time frame
Baseline to month 62
Change in Total Fat Mass
Total fat mass measured by whole-body DXA; change calculated as month 6 minus baseline, in kilograms.
Time frame
Baseline to month 63
Title Change in Visceral Adipose Tissue
Visceral adipose tissue measured using the protocol-specified DXA or CT-derived measure. Enter the final metric and units used by the imaging analysis plan.
Time frame
Baseline to month 64
Change in Bone Mineral Density
Bone mineral density measured by DXA and/or quantitative CT at protocol-specified skeletal sites. Enter the final site-specific metric and units.
Time frame
Baseline to month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
American Diabetes Association
Collaborator
Source ClinicalTrials.gov
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