Physical FitnessMUSSCLENCT02661334
Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise
A study testing Creatine Monohydrate and Rice Flour in people with Physical Fitness, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the physical fitness performance-as measured by the Air Force Physical Fitness Test (PFT)-of subjects that, in conjunction with exercise, will take creatine supplementation over a four week period versus those that do not. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness
- What is being tested?
- Creatine Monohydrate and Rice Flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 13 Feb 2018
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Age ≥18
- Willing to exercise five days per week for four weeks, performing each component of the AF PFT at least once per week
- Willing to adhere to a prescribed supplementation regimen, including spaced dosing two times per day
- Able to meet all study follow-up and testing requirements as outlined in section 6.4 of this protocol
Who cannot join
- History of:
- Chronic kidney dysfunction
- Liver failure
- Rhabdomyolysis
- Compartment syndrome
- Current
Show all 15Show fewer
- Pregnancy
- Musculoskeletal injury
- Fitness exemption from any component of the AF PFT (e.g. AF 469, "profile")
- Kidney injury
- Diabetes
- Hypertension, requiring medication
- Allergy to rice
- Admission to the hospital within the past 30 days
- Creatine supplementation within the past 90 days
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant Medical Center
Fairfield, California, 94535
About this study
Official title: Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise (MUSSCLE)
The purpose of this study is to compare the physical fitness performance-as measured by the Air Force Physical Fitness Test (PFT)-of subjects that, in conjunction with exercise, will take creatine supplementation over a four week period versus those that do not.
Read the detailed description
The purpose of this study is to compare the physical fitness performance-as measured by the Air Force Physical Fitness Test (PFT)-of subjects that, in conjunction with exercise, will take creatine supplementation over a four week period versus those that do not. Based on the literature, there is evidence to support that creatine supplementation may increase available levels of muscle phosphocreatine (PCr), an important energy reservoir that is initially expended with intense muscular contraction and then regenerated during episodes of rest. While mechanistically plausible, the effects of creatine on the specific measures of the PFT (push-ups, sit-ups, 1.5 mile run, and abdominal circumference) have not been evaluated. The target population is Active Duty Air Force (ADAF) service members who perform perform the PFT. As such, this represents a population with occupational requirements to maintain their fitness at a designated level. If short-term creatine supplementation does help to improve PFT scores, trainers, commanders, and unit physicians may wish to consider recommending its use. While generally considered safe, additional data will also be collected to evaluate both the qualitative and quantitative side-effects of creatine supplementation over the study period. If the hypothesis is correct and creatine supplementation is shown to be both effective and safe, additional studies may be warranted to evaluate its impact on ADAF service members who have failed the PFT and/or are at risk of being separated from the AF for unsatisfactory fitness performance. In short, this study has the potential to dramatically affect the recommendations and practices of ADAF service members related to use of creatine supplementation.
- Conditions
- Physical Fitness
- Being tested
- Creatine Monohydrate, Rice Flour
- Keywords
- creatine, creatine monohydrate, supplement, exercise, fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace
Rice FlourDietary supplement
rice flour powder matched for color, appearance, taste, and solubility
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 30g white rice flour Receives: Dietary Supplement: Rice Flour |
| Low dose | Experimental | 5g/day Creatine Monohydrate (25g white rice flour) for 28 days Receives: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Rice Flour |
| Loading dose | Experimental | Creatine Monohydrate 20g/day (10g white rice flour) for 7 days, followed by maintenance dose of Creatine Monohydrate 5g/day (25g white rice flour) for the remaining 21 days Receives: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Rice Flour |
| High dose | Experimental | High dose of Creatine Monohydrate 20g/day (10g white rice flour) for the entire 28 day period Receives: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Rice Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of creatine supplementation on anaerobic performance in the PFT by measuring change in repetitions of push-ups and sit-ups.
An initial mock AF PFT will be administered. Individual component raw numbers, scores, and composite scores will be recorded. Participants will self-take their prescribed regimen twice a day, in addition to exercise 5 days/week. Within 7 days of completing the prescribed treatment and exercise course, participants will undergo another mock AF PFT. The individual component raw numbers, scores, and composite scores will be recorded and compared to initial mock scores
Measured: 28 days
Determine the effect of creatine supplementation on aerobic performance in the PFT by measuring change in 1.5 mile run time.
An initial mock AF PFT will be administered. Individual component raw numbers, scores, and composite scores will be recorded. Participants will self-take their prescribed regimen twice a day, in addition to exercise 5 days/week. Within 7 days of completing the prescribed treatment and exercise course, participants will undergo another mock AF PFT. The individual component raw numbers, scores, and composite scores will be recorded and compared to initial mock scores
Measured: 28 days
Determine the effect of creatine supplementation on body composition as it relates to the PFT by measuring change in abdominal circumference
An initial mock AF PFT will be administered. Individual component raw numbers, scores, and composite scores will be recorded. Participants will self-take their prescribed regimen twice a day, in addition to exercise 5 days/week. Within 7 days of completing the prescribed treatment and exercise course, participants will undergo another mock AF PFT. The individual component raw numbers, scores, and composite scores will be recorded and compared to initial mock scores
Measured: 28 days
Secondary outcomes (5)
Determine how renal function is affected by creatine supplementation by measuring renal function labs (BUN/Creatinine/GFR-with Cys C) before and after the study period.
Labs will be draw before initiation of prescribed treatment. Once the 28-day study period has been completed, each participant will be sent to the DGMC laboratory for a final blood draw
Measured: 28 days
Assess for possible liver damage resulting from creatine supplementation by measuring liver function labs (AST/ALT/Alk Phos) before and after the study period.
Labs will be draw before initiation of prescribed treatment. Once the 28-day study period has been completed, each participant will be sent to the DGMC laboratory for a final blood draw
Measured: 28 days
Evaluate the risk of rhabdomyolysis with creatine supplementation by measuring creatine kinase before and after the study period.
Labs will be draw before initiation of prescribed treatment. Once the 28-day study period has been completed, each participant will be sent to the DGMC laboratory for a final blood draw
Measured: 28 days
Treatment compliance as determined by medication diary.
Participants will be given a log book to record their supplement compliance. They will meet with the study coordinator at the two-week mark (between days 10-14) and review their logbook to ensure they are appropriately taking their supplements. Once the 28-day study period has been completed, each participant with meet with a study team member again to turn in their log book
Measured: 28 days
Quality of workout as determined by exercise diary.
Participants will be given a log book to record their exercise history. They will meet with the study coordinator at the two-week mark (between days 10-14) and review their logbook to ensure they are meeting the requirement of exercising 4 out of 5 days/week. Once the 28-day study period has been completed, each participant with meet with a study team member again to turn in their log book
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start1 Aug 2015
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Why it stopped: Failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephen D Kasteler, MD, Principal investigator, US Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661334
- Sponsor's protocol ID
- FDG20150021H
- Acronym
- MUSSCLE
- Status last verified
- Apr 2020
- First submitted
- 7 Dec 2015
- Last updated
- 3 Apr 2020
- 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 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise (MUSSCLE)
- ClinicalTrials.gov ID
- NCT02661334
- Acronym / sponsor ID
- MUSSCLE / FDG20150021H
- Conditions
- Physical Fitness
- Keywords
- creatine, creatine monohydrate, supplement, exercise, fitness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit
- Enrolment
- 6 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 22 Jan 2016 (estimated)
- 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 of this study is to compare the physical fitness performance-as measured by the Air Force Physical Fitness Test (PFT)-of subjects that, in conjunction with exercise, will take creatine supplementation over a four week period versus those that do not.
Detailed description
The purpose of this study is to compare the physical fitness performance-as measured by the Air Force Physical Fitness Test (PFT)-of subjects that, in conjunction with exercise, will take creatine supplementation over a four week period versus those that do not. Based on the literature, there is evidence to support that creatine supplementation may increase available levels of muscle phosphocreatine (PCr), an important energy reservoir that is initially expended with intense muscular contraction and then regenerated during episodes of rest. While mechanistically plausible, the effects of creatine on the specific measures of the PFT (push-ups, sit-ups, 1.5 mile run, and abdominal circumference) have not been evaluated. The target population is Active Duty Air Force (ADAF) service members who perform perform the PFT. As such, this represents a population with occupational requirements to maintain their fitness at a designated level. If short-term creatine supplementation does help to improve PFT scores, trainers, commanders, and unit physicians may wish to consider recommending its use. While generally considered safe, additional data will also be collected to evaluate both the qualitative and quantitative side-effects of creatine supplementation over the study period. If the hypothesis is correct and creatine supplementation is shown to be both effective and safe, additional studies may be warranted to evaluate its impact on ADAF service members who have failed the PFT and/or are at risk of being separated from the AF for unsatisfactory fitness performance. In short, this study has the potential to dramatically affect the recommendations and practices of ADAF service members related to use of creatine supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Rice Flour30g white rice flour |
| Low dose | Experimental | Dietary Supplement: Creatine Monohydrate, Dietary Supplement: Rice Flour5g/day Creatine Monohydrate (25g white rice flour) for 28 days |
| Loading dose | Experimental | Dietary Supplement: Creatine Monohydrate, Dietary Supplement: Rice FlourCreatine Monohydrate 20g/day (10g white rice flour) for 7 days, followed by maintenance dose of Creatine Monohydrate 5g/day (25g white rice flour) for the remaining 21 days |
| High dose | Experimental | Dietary Supplement: Creatine Monohydrate, Dietary Supplement: Rice FlourHigh dose of Creatine Monohydrate 20g/day (10g white rice flour) for the entire 28 day period |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Age ≥18
- Willing to exercise five days per week for four weeks, performing each component of the AF PFT at least once per week
- Willing to adhere to a prescribed supplementation regimen, including spaced dosing two times per day
- Able to meet all study follow-up and testing requirements as outlined in section 6.4 of this protocol
Key exclusion criteria (15 listed)
- History of:
- Chronic kidney dysfunction
- Liver failure
- Rhabdomyolysis
- Compartment syndrome
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 |
|---|---|---|
| Creatine MonohydrateCreatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace | Dietary supplement | High dose, Loading dose, Low dose |
| Rice Flourrice flour powder matched for color, appearance, taste, and solubility | Dietary supplement | High dose, Loading dose, Low dose, Placebo |
Primary outcome
Determine the effect of creatine supplementation on anaerobic performance in the PFT by measuring change in repetitions of push-ups and sit-ups.
Time frame: 28 days
An initial mock AF PFT will be administered. Individual component raw numbers, scores, and composite scores will be recorded. Participants will self-take their prescribed regimen twice a day, in addition to exercise 5 days/week. Within 7 days of completing the prescribed treatment and exercise course, participants will undergo another mock AF PFT. The individual component raw numbers, scores, and composite scores will be recorded and compared to initial mock scores
Determine the effect of creatine supplementation on aerobic performance in the PFT by measuring change in 1.5 mile run time.
Time frame: 28 days
An initial mock AF PFT will be administered. Individual component raw numbers, scores, and composite scores will be recorded. Participants will self-take their prescribed regimen twice a day, in addition to exercise 5 days/week. Within 7 days of completing the prescribed treatment and exercise course, participants will undergo another mock AF PFT. The individual component raw numbers, scores, and composite scores will be recorded and compared to initial mock scores
Determine the effect of creatine supplementation on body composition as it relates to the PFT by measuring change in abdominal circumference
Time frame: 28 days
An initial mock AF PFT will be administered. Individual component raw numbers, scores, and composite scores will be recorded. Participants will self-take their prescribed regimen twice a day, in addition to exercise 5 days/week. Within 7 days of completing the prescribed treatment and exercise course, participants will undergo another mock AF PFT. The individual component raw numbers, scores, and composite scores will be recorded and compared to initial mock scores
5 secondary outcomes
Determine how renal function is affected by creatine supplementation by measuring renal function labs (BUN/Creatinine/GFR-with Cys C) before and after the study period.
Time frame: 28 days
Assess for possible liver damage resulting from creatine supplementation by measuring liver function labs (AST/ALT/Alk Phos) before and after the study period.
Time frame: 28 days
Evaluate the risk of rhabdomyolysis with creatine supplementation by measuring creatine kinase before and after the study period.
Time frame: 28 days
Treatment compliance as determined by medication diary.
Time frame: 28 days
Quality of workout as determined by exercise diary.
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- 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.
Stephen D Kasteler, MD principal investigator
US Air Force
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 Monohydrate and Rice Flour in people with Physical Fitness, run by David Grant U.S. Air Force Medical Center 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 Apr 2020. 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 was stopped early (reason given: Failure to recruit). Results are not available in the source record.
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?
Determine the effect of creatine supplementation on anaerobic performance in the PFT by measuring change in repetitions of push-ups and sit-ups. (time frame: 28 days). The study lists 3 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 Apr 2020.