HealthyNCT05451498
Creatine Timing on Resistance Training Adaptations in College Athletes
A study testing Creatine and Maltodextrin in people with Healthy, run by Rocky Mountain University of Health Professions at 1 site in United States.
Trial summary
While the use of creatine monohydrate supplementation and its associated benefits are well researched and supported, the impact of the timing of when creatine is ingested is a highly nuanced topic. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Creatine and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 5 May 2022
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 19 years of age but less than 30 years of age.
- Current member of Midland University athletic team completing off-season resistance training program.
- Participants will be healthy as determined by evaluation of medical history and if they are cleared to participate in their sport, they are cleared to participate in the study (as deemed by the team medical provider i.e. Certified Athletic Trainer).
Who cannot join
- As indicated on a medical history form they complete, any individual who is currently being treated or is diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic obesity (defined as body mass index >35 kg/m2 and body fat greater than 30%), immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder or disease will be excluded.
- Individuals with allergies to milk or soy (lecithin).
- For females only, if they are currently pregnant or become pregnant at any point throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain University of Health Professions
Provo, Utah, 84601
About this study
Official title: Effects of Creatine Monohydrate Timing on Resistance Training Adaptations in Male and Female Collegiate Athletes
While the use of creatine monohydrate supplementation and its associated benefits are well researched and supported, the impact of the timing of when creatine is ingested is a highly nuanced topic. The potential for the timing of administration to make an impact on observed outcomes is an established and appreciated factor and limited research to date has examined the impact of creatine timing. Of the literature that has been published, one study was very short in duration (4 weeks) that possessed a study design that undermined its practicality, two other studies used older individuals, and one study utilized a unilateral training model which may not be an adequate exercise protocol to allow for the ergogenic potential of creatine to mediate any enhancement of training adaptations. Therefore, based on the limited number of studies in young and previously trained populations, future studies examining the effects of pre vs post-training creatine monohydrate supplementation on resistance training adaptations are warranted.
Read the detailed description
In a randomized, double-blind, placebo-controlled, parallel design, eligible study participants were provided a daily dose of creatine monohydrate (pre-or post-workout) or placebo (no creatine delivered) for an 8-week supplementation period. Based upon their baseline fat-free mass, participants were randomized into one of three groups: pre-workout creatine supplementation (PRE), post-workout creatine supplementation (POST), or placebo (PLA). Each group consumed their assigned dose or placebo within one hour before exercise and within one hour following exercise. Each assigned supplement was consumed with 12-16 ounces of fluid along with a 25-gram dose of whey protein isolate and a 25-gram dose of carbohydrate powder This additional supplementation was provided to aid in blinding and to help ensure adequate dietary protein intake was provided to promote increases in lean body mass and strength. Providing daily doses of carbohydrates and protein also helped with recruitment efforts as all study participants received some efficacious nutrients.
All participants completed a twelve-week resistance training and conditioning program. The first four weeks of resistance training (12 workouts) occurred before supplementation began and were completed to acclimate participants to the program and to initiate early neuromuscular adaptations commonly seen with starting a new resistance training program. In addition, this initial 4-week period allowed for some study participants to wash out from ongoing supplementation prior to beginning the supplementation protocol. After completion of this run-in period, participants then completed baseline testing as described and began the supplementation protocol while continuing to follow the resistance training program for an additional eight weeks. Before and after the 8-week supplementation and resistance training period, body mass, body water, and body composition were assessed in addition to changes in muscular strength, muscular endurance, and lower-body power. All statistical analysis was completed on data collected starting at the beginning and end of the supplementation period. Participants were provided nutritional recommendations in order to ensure adequate energy and protein consumption to facilitate positive training adaptations and reduce the potential influence of differing dietary intakes.
- Conditions
- Healthy
- Being tested
- Creatine, Maltodextrin
- Keywords
- supplementation, pre-workout, post-workout, peri-workout, strength, endurance, body composition, fat-free mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Participants were matched according to fat-free mass to consume a placebo, or 5-g dose of creatine monohydrate within one hour before training, or within one hour after training for 8 weeks while completing a weekly resistance training program. At each time point (before and after training), all participants co-ingested a 25-gram dose whey isolate and a 25-gram dose of carbohydrate powder along with their assigned supplement. Body composition using a 3-compartment field (3CFIELD), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF] at 80% 1RM) using bench press (BP) and back squat (SQ) exercises along with isometric mid-thigh pull (IMTP) were assessed before and after the 8-week supplementation period.
MaltodextrinDietary supplement
Participants were matched according to fat-free mass to consume a placebo (maltodextrin) within one hour before training, or within one hour after training for 8 weeks while completing a weekly resistance training program. At each time point (before and after training), all participants co-ingested a 25-gram dose whey isolate and a 25-gram dose of carbohydrate powder along with their assigned supplement. Body composition using a 3-compartment field (3CFIELD), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF] at 80% 1RM) using bench press (BP) and back squat (SQ) exercises along with isometric mid-thigh pull (IMTP) were assessed before and after the 8-week supplementation period.
| Study group | Role | What they receive |
|---|---|---|
| Creatine Pre-Exercise | Experimental | Consumes creatine within one hour before training and placebo within one hour after training Receives: Dietary Supplement: Creatine |
| Creatine Post-Exercise | Experimental | Consumes placebo within one hour before training and creatine within one hour after training Receives: Dietary Supplement: Creatine |
| Placebo | Placebo comparator | Consumes placebo within one hour before training and placebo within one hour after training Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat-Free Mass
3-compartment field (3CFIELD)
Measured: 8 weeks
Lower Body Strength
Back Squat 1 repetition maximum according to standard protocols
Measured: 8 weeks
Secondary outcomes (6)
Fat Mass
3-compartment field (3CFIELD)
Measured: 8 weeks
Body Fat Percentage
3-compartment field (3CFIELD)
Measured: 8 weeks
Total Body Water
Determined by bioelectrical impedance spectroscopy
Measured: 8 weeks
Upper Body Strength
Bench Press 1 repetition maximum according to standard protocols
Measured: 8 weeks
Lower Body Muscular Endurance
80% 1 RM Back Squat repetitions to fatigue
Measured: 8 weeks
Upper Body Muscular Endurance
80% 1 RM Bench press repetitions to fatigue
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start9 Feb 2022
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- randomized, double-blind, placebo-controlled, parallel design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain University of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- Lindenwood University, Mayo Clinic, Western Michigan University
- Responsible party
- Principal investigator, Nicholas Dinan, Rocky Mountain University of Health Professions
- Investigators
- Nicholas E Dinan, MS, Principal investigator, Rocky Mountain University of Health ProfessionsChad M Kerksick, PhD, Study chair, Lindenwood UniversityAndrew R Jagim, PhD, Study director, Mayo Clinic Health SystemMichael G Miller, PhD, Study director, Western Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451498
- Sponsor's protocol ID
- Protocol #2021-28
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Monohydrate Timing on Resistance Training Adaptations in Male and Female Collegiate Athletes
- ClinicalTrials.gov ID
- NCT05451498
- Acronym / sponsor ID
- Protocol #2021-28
- Conditions
- Healthy
- Keywords
- supplementation, pre-workout, post-workout, peri-workout, strength, endurance, body composition, fat-free mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Rocky Mountain University of Health ProfessionsUniversity, hospital or other
- Collaborators
- Lindenwood University, Mayo Clinic, Western Michigan University
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 11 Jul 2022 (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.
While the use of creatine monohydrate supplementation and its associated benefits are well researched and supported, the impact of the timing of when creatine is ingested is a highly nuanced topic. The potential for the timing of administration to make an impact on observed outcomes is an established and appreciated factor and limited research to date has examined the impact of creatine timing. Of the literature that has been published, one study was very short in duration (4 weeks) that possessed a study design that undermined its practicality, two other studies used older individuals, and one study utilized a unilateral training model which may not be an adequate exercise protocol to allow for the ergogenic potential of creatine to mediate any enhancement of training adaptations. Therefore, based on the limited number of studies in young and previously trained populations, future studies examining the effects of pre vs post-training creatine monohydrate supplementation on resistance training adaptations are warranted.
Detailed description
In a randomized, double-blind, placebo-controlled, parallel design, eligible study participants were provided a daily dose of creatine monohydrate (pre-or post-workout) or placebo (no creatine delivered) for an 8-week supplementation period. Based upon their baseline fat-free mass, participants were randomized into one of three groups: pre-workout creatine supplementation (PRE), post-workout creatine supplementation (POST), or placebo (PLA). Each group consumed their assigned dose or placebo within one hour before exercise and within one hour following exercise. Each assigned supplement was consumed with 12-16 ounces of fluid along with a 25-gram dose of whey protein isolate and a 25-gram dose of carbohydrate powder This additional supplementation was provided to aid in blinding and to help ensure adequate dietary protein intake was provided to promote increases in lean body mass and strength. Providing daily doses of carbohydrates and protein also helped with recruitment efforts as all study participants received some efficacious nutrients.
All participants completed a twelve-week resistance training and conditioning program. The first four weeks of resistance training (12 workouts) occurred before supplementation began and were completed to acclimate participants to the program and to initiate early neuromuscular adaptations commonly seen with starting a new resistance training program. In addition, this initial 4-week period allowed for some study participants to wash out from ongoing supplementation prior to beginning the supplementation protocol. After completion of this run-in period, participants then completed baseline testing as described and began the supplementation protocol while continuing to follow the resistance training program for an additional eight weeks. Before and after the 8-week supplementation and resistance training period, body mass, body water, and body composition were assessed in addition to changes in muscular strength, muscular endurance, and lower-body power. All statistical analysis was completed on data collected starting at the beginning and end of the supplementation period. Participants were provided nutritional recommendations in order to ensure adequate energy and protein consumption to facilitate positive training adaptations and reduce the potential influence of differing dietary intakes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- randomized, double-blind, placebo-controlled, parallel design
| Arm | Type | Receives |
|---|---|---|
| Creatine Pre-Exercise | Experimental | Dietary Supplement: CreatineConsumes creatine within one hour before training and placebo within one hour after training |
| Creatine Post-Exercise | Experimental | Dietary Supplement: CreatineConsumes placebo within one hour before training and creatine within one hour after training |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinConsumes placebo within one hour before training and placebo within one hour after training |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least 19 years of age but less than 30 years of age.
- Current member of Midland University athletic team completing off-season resistance training program.
- Participants will be healthy as determined by evaluation of medical history and if they are cleared to participate in their sport, they are cleared to participate in the study (as deemed by the team medical provider i.e. Certified Athletic Trainer).
Key exclusion criteria (3 listed)
- As indicated on a medical history form they complete, any individual who is currently being treated or is diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic obesity (defined as body mass index >35 kg/m2 and body fat greater than 30%), immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder or disease will be excluded.
- Individuals with allergies to milk or soy (lecithin).
- For females only, if they are currently pregnant or become pregnant at any point throughout the study.
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 |
|---|---|---|
| CreatineParticipants were matched according to fat-free mass to consume a placebo, or 5-g dose of creatine monohydrate within one hour before training, or within one hour after training for 8 weeks while completing a weekly resistance training program. At each time point (before and after training), all participants co-ingested a 25-gram dose whey isolate and a 25-gram dose of carbohydrate powder along with their assigned supplement. Body composition using a 3-compartment field (3CFIELD), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF] at 80% 1RM) using bench press (BP) and back squat (SQ) exercises along with isometric mid-thigh pull (IMTP) were assessed before and after the 8-week supplementation period. | Dietary supplement | Creatine Post-Exercise, Creatine Pre-Exercise |
| MaltodextrinParticipants were matched according to fat-free mass to consume a placebo (maltodextrin) within one hour before training, or within one hour after training for 8 weeks while completing a weekly resistance training program. At each time point (before and after training), all participants co-ingested a 25-gram dose whey isolate and a 25-gram dose of carbohydrate powder along with their assigned supplement. Body composition using a 3-compartment field (3CFIELD), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF] at 80% 1RM) using bench press (BP) and back squat (SQ) exercises along with isometric mid-thigh pull (IMTP) were assessed before and after the 8-week supplementation period. | Dietary supplement | Placebo |
Primary outcome
Fat-Free Mass
Time frame: 8 weeks
3-compartment field (3CFIELD)
Lower Body Strength
Time frame: 8 weeks
Back Squat 1 repetition maximum according to standard protocols
6 secondary outcomes
Fat Mass
Time frame: 8 weeks
Body Fat Percentage
Time frame: 8 weeks
Total Body Water
Time frame: 8 weeks
Upper Body Strength
Time frame: 8 weeks
Lower Body Muscular Endurance
Time frame: 8 weeks
Upper Body Muscular Endurance
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- 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.
Nicholas E Dinan, MS principal investigator
Rocky Mountain University of Health Professions
Chad M Kerksick, PhD study chair
Lindenwood University
Andrew R Jagim, PhD study director
Mayo Clinic Health System
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 and Maltodextrin in people with Healthy, run by Rocky Mountain University of Health Professions at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 12 Jul 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat-Free Mass (time frame: 8 weeks). The study lists 2 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 12 Jul 2022.