Clinical trial NCT02661334: Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise
Official title: Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise (MUSSCLE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Physical Fitness
Keywords: creatine
creatine monohydrate
supplement
exercise
fitness
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2016-01-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the effect of creatine supplementation on anaerobic performance in the PFT by measuring change in repetitions of push-ups and sit-ups.
timeFrame: 28 days
measure: Determine the effect of creatine supplementation on aerobic performance in the PFT by measuring change in 1.5 mile run time.
timeFrame: 28 days
measure: Determine the effect of creatine supplementation on body composition as it relates to the PFT by measuring change in abdominal circumference
timeFrame: 28 days
Secondary outcomes:
measure: 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.
timeFrame: 28 days
measure: Assess for possible liver damage resulting from creatine supplementation by measuring liver function labs (AST/ALT/Alk Phos) before and after the study period.
timeFrame: 28 days
measure: Evaluate the risk of rhabdomyolysis with creatine supplementation by measuring creatine kinase before and after the study period.
timeFrame: 28 days
measure: Treatment compliance as determined by medication diary.
timeFrame: 28 days
measure: Quality of workout as determined by exercise diary.
timeFrame: 28 days
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: David Grant Medical Center
state: California
Study officials:
affiliation: US Air Force
name: Stephen D Kasteler, MD
role: PRINCIPAL_INVESTIGATOR
References: