Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise

Physical Fitness Clinical Trial

— MUSSCLE  

Official title:

Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise (MUSSCLE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02661334
• Other study ID #: FDG20150021H
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: February 13, 2018

Study information

• Verified date: April 2020
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 13, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Fitness

Intervention

Dietary Supplement:
• Creatine Monohydrate
Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace
• Rice Flour
rice flour powder matched for color, appearance, taste, and solubility

Locations

Country	Name	City	State
United States	David Grant Medical Center	Fairfield	California

Sponsors (1)

Lead Sponsor	Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Primary	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	28 days
Primary	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	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	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	28 days
Secondary	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	28 days