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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • SK - Saskatchewan
      • Saskatoon, SK - Saskatchewan, Canada, S7N 5B2
        • Recruiting
        • University of Saskatchewan
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo (maltodextrin)
Dietary supplement: Dietary supplementation during a 12 week resistance-training program (placebo)
Placebo
Experimental: Creatine
10 grams per day creatine
Dietary supplement: Dietary supplementation during a 12 week resistance-training program (creatine)
creatine supplementation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Saskatchewan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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