Strategic Ingestion of Creatine Supplementation and Resistance Training in Trained Young Adults

May 29, 2024 updated by: Darren Candow, University of Regina
Creatine supplementation improves measures of muscle accretion and performance compared to placebo during a resistance training program. However, the optimal creatine supplementation protocol for maximizing these improvements is unknown.

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

Creatine is a naturally occurring nitrogen containing compound endogenously produced in the body through reactions involving the amino acids arginine, glycine and methionine. Alternatively, creatine can be consumed in the diet (primarily from red meat and seafood) or through commercially manufactured creatine. It has been proposed that the strategic ingestion of creatine supplementation may be an important factor to consider during a resistance training program to increase muscle growth and performance. There is evidence that creatine supplementation only on training days has greater muscle benefits compared to placebo in healthy older adults. However, the effects of creatine on training days (compared to creatine on non-training days or placebo) in healthy young adults is unknown. Further, pre- and post-exercise creatine supplementation appears to produce similar muscle benefits (compared to placebo) in healthy older adults. It remains to be determined whether the timing of creatine ingestion (immediately before vs. immediately following training sessions) influences the physiological adaptations from resistance training compared to placebo in young healthy adults. It is also unknown whether differences exist in supplementing with creatine immediately before, during or immediately following resistance training sessions in young healthy adults.

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.
52

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
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S4H4
        • Recruiting
        • University of Regina
        • Contact:
        • Principal Investigator:
          • Darren G Candow, PhD

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Physically active (performing structured resistance training > 2x/week for ≥ 4 weeks)
  • Males and females (age 18-39)

Exclusion Criteria:

  • Pregnant or nursing
  • Have consumed creatine monohydrate within 30 days prior to the start of the study
  • Pre-existing allergies to the placebo

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Experimental: Creatine Before Training
5 grams of creatine monohydrate + 3 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days.
Dietary supplement: Placebo
Corn-Starch Maltodextrin
Dietary supplement: Creatine monohydrate
Creatine
Experimental: Creatine After Training
5 grams of creatine monohydrate + 3 grams of placebo immediately after training sessions; 8 grams of placebo immediately before training sessions; 8 grams of placebo on non-training days.
Dietary supplement: Placebo
Corn-Starch Maltodextrin
Dietary supplement: Creatine monohydrate
Creatine
Experimental: Creatine Non-Training
5 grams of creatine monohydrate + 3 grams of placebo on non-training days; 8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions.
Dietary supplement: Placebo
Corn-Starch Maltodextrin
Dietary supplement: Creatine monohydrate
Creatine
Placebo Comparator: Placebo
8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days
Dietary supplement: Placebo
Corn-Starch Maltodextrin

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
Body Composition
Time Frame: baseline, week 16
Whole-body lean mass (kg) using bioelectrical impedance analysis
baseline, week 16
Muscle Hypertrophy
Time Frame: baseline, week 16
Muscle thickness of the biceps, triceps, quadriceps, hamstrings and calf muscle using B-mode ultrasound (cm)
baseline, week 16
Strength
Time Frame: baseline, week 16
1-repetition maximum leg press and chest press (kg)
baseline, week 16
Endurance
Time Frame: baseline, week 16
Repetitions to fatigue for leg press and chest press (total number)
baseline, week 16
Power
Time Frame: baseline, week 16
Medicine ball throw (cm)
baseline, week 16
Hydration
Time Frame: baseline, week 16
Total body water (kg) using bioelectrical impedance analysis
baseline, week 16
Power
Time Frame: baseline, weekn 16
Vertical jump (watts)
baseline, weekn 16

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 Regina

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: Darren Candow, University of Regina

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 15, 2024

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.
December 30, 2024

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.
August 30, 2025

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 16, 2024

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 29, 2024

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 3, 2024

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 3, 2024

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 29, 2024

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, 2024

More Information

Terms related to this study

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.
  • Bio-REB 4641

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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