- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02661334
Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise (MUSSCLE)
April 1, 2020 updated by: David Grant U.S. Air Force Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- 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 Locations
-
-
California
-
Fairfield, California, United States, 94535
- David Grant Medical Center
-
-
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
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of:
- Chronic kidney dysfunction
- Liver failure
- Rhabdomyolysis
- Compartment syndrome
- Current
- 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
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
30g white rice flour
|
rice flour powder matched for color, appearance, taste, and solubility
|
Experimental: Low dose
5g/day Creatine Monohydrate (25g white rice flour) for 28 days
|
rice flour powder matched for color, appearance, taste, and solubility
Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace
|
Experimental: Loading dose
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
|
rice flour powder matched for color, appearance, taste, and solubility
Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace
|
Experimental: High dose
High dose of Creatine Monohydrate 20g/day (10g white rice flour) for the entire 28 day period
|
rice flour powder matched for color, appearance, taste, and solubility
Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days
|
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
|
28 days
|
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
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
28 days
|
Evaluate the risk of rhabdomyolysis with creatine supplementation by measuring creatine kinase before and after the study period.
Time Frame: 28 days
|
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
|
28 days
|
Treatment compliance as determined by medication diary.
Time Frame: 28 days
|
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
|
28 days
|
Quality of workout as determined by exercise diary.
Time Frame: 28 days
|
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
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen D Kasteler, MD, US Air Force
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)
August 1, 2015
Primary Completion (Actual)
February 13, 2018
Study Completion (Actual)
February 13, 2018
Study Registration Dates
First Submitted
December 7, 2015
First Submitted That Met QC Criteria
January 19, 2016
First Posted (Estimate)
January 22, 2016
Study Record Updates
Last Update Posted (Actual)
April 3, 2020
Last Update Submitted That Met QC Criteria
April 1, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- FDG20150021H
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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