Improve Muscle Performance in Young AdultsNCT06604793
Creatine Supplementation in Young Healthy Adults
A study testing Creatine in people with Improve Muscle Performance in Young Adults, run by University of Regina at 1 site in Canada.
Trial summary
The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Improve Muscle Performance in Young Adults
- What is being tested?
- Creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2024to 31 Jan 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
- if you are 18-39 years of age
- if you have not been performing resistance training for at least 4 weeks prior to the start of the study.
Who cannot join
- if you are pregnant or nursing
- have taken creatine monohydrate within 30 days prior to the start of the study
- if you have pre-existing allergies to the placebo (corn-starch maltodextrin)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S 0A2
Darren Candow, 306-585-4096, Darren.Candow@uregina.ca
About this study
Official title: Effects of Equal-volume Creatine Supplementation With Different Dosing Strategies on Body Composition and Muscle Performance in Young Healthy Adults
The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance).
Read the detailed description
Creatine is a naturally occurring compound produced in the liver and brain. Creatine can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products (i.e. creatine supplementation).
Evidence-based research shows that creatine supplementation improves measures of body composition and muscle performance. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.
- Being tested
- Creatine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Creatine monohydrate
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Creatine Bolus | Experimental | (Serving 1: 5 grams of creatine monohydrate + 3 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days. Receives: Dietary Supplement: Creatine |
| Creatine Intermittent | Experimental | (Serving 1: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the morning; Serving 2: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the evening) for 21 days. Receives: Dietary Supplement: Creatine |
| Placebo | Placebo comparator | (Servings 1: 8 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body lean mass (kg)
Bioelectrical impedance analysis
Measured: baseline, day 21
Strength
1-repetition maximum leg press and chest press (kg)
Measured: baseline, day 21
Endurance
Repetitions to fatigue for leg press and chest press (total number)
Measured: baseline, day 21
Hydration
Total body water (kg) using bioelectrical impedance analysis
Measured: baseline, day 21
Power
Vertical Jump (cm)
Measured: baseline, day 21
Power
Medicine Ball Throw (feet)
Measured: baseline, day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start20 Aug 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improve Muscle Performance in Young AdultsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Responsible party
- Principal investigator, Darren Candow, University of Regina
- Investigators
- Darren Candow, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604793
- Sponsor's protocol ID
- 834
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 20 Sep 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 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Equal-volume Creatine Supplementation With Different Dosing Strategies on Body Composition and Muscle Performance in Young Healthy Adults
- ClinicalTrials.gov ID
- NCT06604793
- Acronym / sponsor ID
- 834
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Iovate Health Sciences International Inc
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 20 Sep 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.
The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance).
Detailed description
Creatine is a naturally occurring compound produced in the liver and brain. Creatine can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products (i.e. creatine supplementation).
Evidence-based research shows that creatine supplementation improves measures of body composition and muscle performance. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Creatine Bolus | Experimental | Dietary Supplement: Creatine(Serving 1: 5 grams of creatine monohydrate + 3 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days. |
| Creatine Intermittent | Experimental | Dietary Supplement: Creatine(Serving 1: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the morning; Serving 2: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the evening) for 21 days. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo(Servings 1: 8 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- if you are 18-39 years of age
- if you have not been performing resistance training for at least 4 weeks prior to the start of the study.
Key exclusion criteria (3 listed)
- if you are pregnant or nursing
- have taken creatine monohydrate within 30 days prior to the start of the study
- if you have pre-existing allergies to the placebo (corn-starch maltodextrin)
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 |
|---|---|---|
| CreatineCreatine monohydrate | Dietary supplement | Creatine Bolus, Creatine Intermittent |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Whole-body lean mass (kg)
Time frame: baseline, day 21
Bioelectrical impedance analysis
Strength
Time frame: baseline, day 21
1-repetition maximum leg press and chest press (kg)
Endurance
Time frame: baseline, day 21
Repetitions to fatigue for leg press and chest press (total number)
Hydration
Time frame: baseline, day 21
Total body water (kg) using bioelectrical impedance analysis
Power
Time frame: baseline, day 21
Vertical Jump (cm)
Power
Time frame: baseline, day 21
Medicine Ball Throw (feet)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Improve Muscle Performance in Young Adults, run by University of Regina at 1 site 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (306-585-4906, Darren.Candow@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body lean mass (kg) (time frame: baseline, day 21). The study lists 6 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 20 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.