StrengthNCT06438887
Strategic Ingestion of Creatine Supplementation and Resistance Training in Trained Young Adults
A study testing Creatine monohydrate in people with Strength and Muscle, run by University of Regina at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- What is being tested?
- Creatine monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesCanada
- Study dates
- 15 May 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active (performing structured resistance training > 2x/week for ≥ 4 weeks)
- Males and females (age 18-39)
Who cannot join
- Pregnant or nursing
- Have consumed creatine monohydrate within 30 days prior to the start of the study
- Pre-existing allergies to the placebo
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S4H4
Darren G Candow, PhD, 3062090280, Darren.Candow@uregina.ca
Darren G Candow, PhD
- Recruiting
University of Regina
Regina
Darren Candow, Darren.Candow@uregina.ca
About this study
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.
Read the 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.
- Being tested
- Placebo, Creatine monohydrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Corn-Starch Maltodextrin
Creatine monohydrateDietary supplement
Creatine
| Study group | Role | What they receive |
|---|---|---|
| Creatine Before Training | Experimental | 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. Receives: Dietary Supplement: Placebo; Dietary Supplement: Creatine monohydrate |
| Creatine After Training | Experimental | 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. Receives: Dietary Supplement: Placebo; Dietary Supplement: Creatine monohydrate |
| Creatine Non-Training | Experimental | 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. Receives: Dietary Supplement: Placebo; Dietary Supplement: Creatine monohydrate |
| Placebo | Placebo comparator | 8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Whole-body lean mass (kg) using bioelectrical impedance analysis
Measured: baseline, week 16
Muscle Hypertrophy
Muscle thickness of the biceps, triceps, quadriceps, hamstrings and calf muscle using B-mode ultrasound (cm)
Measured: baseline, week 16
Strength
1-repetition maximum leg press and chest press (kg)
Measured: baseline, week 16
Endurance
Repetitions to fatigue for leg press and chest press (total number)
Measured: baseline, week 16
Power
Medicine ball throw (cm)
Measured: baseline, week 16
Hydration
Total body water (kg) using bioelectrical impedance analysis
Measured: baseline, week 16
Power
Vertical jump (watts)
Measured: baseline, weekn 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 May 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Candow, University of Regina
- Investigators
- Darren Candow, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438887
- Sponsor's protocol ID
- Bio-REB 4641
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Ingestion of Creatine Supplementation and Resistance Training in Trained Young Adults
- ClinicalTrials.gov ID
- NCT06438887
- Acronym / sponsor ID
- Bio-REB 4641
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Creatine Before Training | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Creatine monohydrate5 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. |
| Creatine After Training | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Creatine monohydrate5 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. |
| Creatine Non-Training | Experimental | Dietary Supplement: Placebo, Dietary Supplement: Creatine monohydrate5 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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physically active (performing structured resistance training > 2x/week for ≥ 4 weeks)
- Males and females (age 18-39)
Key exclusion criteria (3 listed)
- Pregnant or nursing
- Have consumed creatine monohydrate within 30 days prior to the start of the study
- Pre-existing allergies to the placebo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboCorn-Starch Maltodextrin | Dietary supplement | Creatine After Training, Creatine Before Training, Creatine Non-Training, Placebo |
| Creatine monohydrateCreatine | Dietary supplement | Creatine After Training, Creatine Before Training, Creatine Non-Training |
Primary outcome
Body Composition
Time frame: baseline, week 16
Whole-body lean mass (kg) using bioelectrical impedance analysis
Muscle Hypertrophy
Time frame: baseline, week 16
Muscle thickness of the biceps, triceps, quadriceps, hamstrings and calf muscle using B-mode ultrasound (cm)
Strength
Time frame: baseline, week 16
1-repetition maximum leg press and chest press (kg)
Endurance
Time frame: baseline, week 16
Repetitions to fatigue for leg press and chest press (total number)
Power
Time frame: baseline, week 16
Medicine ball throw (cm)
Hydration
Time frame: baseline, week 16
Total body water (kg) using bioelectrical impedance analysis
Power
Time frame: baseline, weekn 16
Vertical jump (watts)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Candow principal investigator
University of Regina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine monohydrate in people with Strength and Muscle, run by University of Regina at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darren Candow (3062090280, Darren.Candow@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: baseline, week 16). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.