Calcium-HMB + Vitamin D for Muscle Loss in Older Adults

(PRESERVE-HMB Trial)

RF
Overseen ByRobb Flynn, PhD
Age: 65+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vanderbilt University Medical Center
Must be taking: Semaglutide
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

RF

Robb Flynn, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 65 to 85 with type 2 diabetes who are starting semaglutide treatment. Participants should be generally healthy aside from their diabetes and related conditions like obesity or muscle loss.

Inclusion Criteria

Body mass index at or above 27 kg/m2
I am able to understand the study and give my consent.
English speaking for the initial study because consent documents, questionnaires, study-product instructions, safety instructions, and procedure-specific materials are available only in English
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Exclusion Criteria

Weight change greater than 5% during the previous 3 months
Estimated glomerular filtration rate below 45 mL/min/1.73 m2
I or my family have a history of medullary thyroid cancer or MEN2 syndrome.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive calcium-HMB plus vitamin D3 or placebo for approximately 6 months while semaglutide is managed as standard clinical care

6 months
Visits at baseline, month 3, and month 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Mechanistic Substudy

Participants undergo additional assessments including D3-creatine dilution, stable isotope infusions, and muscle biopsies

Baseline and month 6

What Are the Treatments Tested in This Trial?

Interventions

  • Calcium beta-hydroxy-beta-methylbutyrate (Calcium-HMB) plus Vitamin D3

Trial Overview

The study tests whether taking calcium-HMB plus vitamin D3 daily, compared to a placebo, helps preserve muscle mass and function in older adults on semaglutide over about six months. It uses a randomized, double-blind design.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Calcium-HMB Plus Vitamin D3Experimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

American Diabetes Association

Collaborator

Trials
148
Recruited
102,000+