- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07625202
Creatine Supplementation During GLP-1a Therapy
May 30, 2026 updated by: Phil Chilibeck, University of Saskatchewan
A Pilot Study on Creatine Supplementation During Resistance-training for Prevention of Lean Tissue Mass Loss During GLP-1 Receptor Agonist Therapy
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Philip D Chilibeck, PhD
- Phone Number: 306-966-1072
- Email: phil.chilibeck@usask.ca
Study Locations
-
-
SK - Saskatchewan
-
Saskatoon, SK - Saskatchewan, Canada, S7N 5B2
- Recruiting
- University of Saskatchewan
-
Contact:
- Philip D Chilibeck, PhD
- Phone Number: 306-966-1072
- Email: phil.chilibeck@usask.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Placebo (maltodextrin)
|
Placebo
|
|
Experimental: Creatine
10 grams per day creatine
|
creatine supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sit to stand performance (number of times)
Time Frame: 12 weeks
|
change in number of times sitting and standing in 30 seconds
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 10 meter gait speed (m/s)
Time Frame: 12 weeks
|
change in walking speed over 10 meters
|
12 weeks
|
|
Change in timed up and go (m/s)
Time Frame: 12 weeks
|
change in time to stand up, walk 3m, turn, around, walk 3 m and sit down
|
12 weeks
|
|
Change in lean tissue mass (kg)
Time Frame: 12 weeks
|
Change in lean tissue mass as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in fat mass (kg)
Time Frame: 12 weeks
|
Change in fat mass as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in whole body bone mineral density (g/cm squared)
Time Frame: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in femoral neck bone mineral density (g/cm squared)
Time Frame: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in total hip bone mineral density (g/cm squared)
Time Frame: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in lumbar spine bone mineral density (g/cm squared)
Time Frame: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in hip section modulus (cm-cubed)
Time Frame: 12 weeks
|
Change in hip section modulus as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in muscle thickness of the biceps (cm)
Time Frame: 12 weeks
|
Change in muscle thickness measured by ultrasound
|
12 weeks
|
|
Change in muscle thickness of the quadriceps (cm)
Time Frame: 12 weeks
|
Change in muscle thickness measured by ultrasound
|
12 weeks
|
|
Change in bench press strength (kg)
Time Frame: 12 weeks
|
change in upper body strength measured by predicted one repetition maximum
|
12 weeks
|
|
Change in leg extension strength (kg)
Time Frame: 12 weeks
|
Change in lower body strength measured by predicted one repetition maximum
|
12 weeks
|
|
Change in hip buckling ratio (ratio)
Time Frame: 12 weeks
|
Change in hip buckling ratio as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in hip cross-sectional area (cm-squared)
Time Frame: 12 weeks
|
Change in hip cross-sectional area as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in hip cortical thickness (cm)
Time Frame: 12 weeks
|
Change in hip cortical thickness as determined by dual energy x-ray absorptiometry
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philip Chilibeck, PhD, University of Saskatchewan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2026
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
May 25, 2026
First Submitted That Met QC Criteria
May 30, 2026
First Posted (Actual)
June 4, 2026
Study Record Updates
Last Update Posted (Actual)
June 4, 2026
Last Update Submitted That Met QC Criteria
May 30, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sarcopenia
- Amino Acids, Peptides, and Proteins
- Organic Chemicals
- Amino Acids
- Guanidines
- Amidines
- Creatine
Other Study ID Numbers
- 6372
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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