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Recruiting NCT07625202

Creatine Supplementation During GLP-1a Therapy

No phase Interventional Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dietary supplementation during a 12 week resistance-training program (creatine), Dietary supplementation during a 12 week resistance-training program (placebo).
Who it may be relevant to
Registry conditions: Sarcopenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Study on Creatine Supplementation During Resistance-training for Prevention of Lean Tissue Mass Loss During GLP-1 Receptor Agonist Therapy

Overview

GLP-1 receptor agonists are effective for weight loss, but significant muscle mass is lost as a proportion of this weight loss. This study combines resistance-training and creatine supplementation to try to prevent this loss of muscle mass.

Detailed description

GLP-1 receptor agonists are highly effective for weight loss and increasing in popularity for those trying to lose weight. One concern with these medications is the potential for loss of lean tissue mass during rapid weight loss. This may affect strength and functional performance in people taking these medications. Resistance-training helps to offset loss of muscle mass during weight loss. Supplementation with creatine monohydrate is also effective for improving muscle mass and strength. The purpose of this pilot study is to determine the effectiveness of creatine supplementation during a resistance training program in people who are starting GLP-receptor agonist medication for preventing loss of lean tissue mass and functional performance. The investigators will randomize 40 people who are starting GLP-1 agonists to receive either 10g per day creatine or placebo during a resistance-training program (i.e., resistance-training three days per week for 12 weeks). It is hypothesized that participants on the creatine supplement will have superior maintenance of lean tissue mass and function performance compared to participants taking placebo.

Interventions

  • Dietary supplement Dietary supplementation during a 12 week resistance-training program (creatine)
    creatine supplementation
  • Dietary supplement Dietary supplementation during a 12 week resistance-training program (placebo)
    Placebo

Primary outcome measures

  • Change in sit to stand performance (number of times) [Time frame: 12 weeks]
Secondary outcome measures (12)
  • Change in 10 meter gait speed (m/s) [Time frame: 12 weeks]
  • Change in timed up and go (m/s) [Time frame: 12 weeks]
  • Change in lean tissue mass (kg) [Time frame: 12 weeks]
  • Change in fat mass (kg) [Time frame: 12 weeks]
  • Change in whole body bone mineral density (g/cm squared) [Time frame: 12 weeks]
  • Change in femoral neck bone mineral density (g/cm squared) [Time frame: 12 weeks]
  • Change in total hip bone mineral density (g/cm squared) [Time frame: 12 weeks]
  • Change in lumbar spine bone mineral density (g/cm squared) [Time frame: 12 weeks]
  • Change in hip section modulus (cm-cubed) [Time frame: 12 weeks]
  • Change in muscle thickness of the biceps (cm) [Time frame: 12 weeks]
  • Change in muscle thickness of the quadriceps (cm) [Time frame: 12 weeks]
  • Change in bench press strength (kg) [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • Starting GLP-1 agonist therapy
  • 18 years of age or older

Exclusion criteria

  • Positive answers to a screening questionnaire for physical activity safety (the Get Active Questionnaire)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Canada · 1 center
  • University of Saskatchewan — Saskatoon

Identifiers

NCT: NCT07625202 · 6372

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗