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

David Grant U.S. Air Force Medical Center

Status

Terminated

Conditions

Physical Fitness

Treatments

Dietary Supplement: Rice Flour

Dietary Supplement: Creatine Monohydrate

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02661334

FDG20150021H

Details and patient eligibility

About

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

6 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

30g white rice flour

Treatment:

Dietary Supplement: Rice Flour

Low dose

Experimental group

Description:

5g/day Creatine Monohydrate (25g white rice flour) for 28 days

Treatment:

Dietary Supplement: Creatine Monohydrate

Dietary Supplement: Rice Flour

Loading dose

Experimental group

Description:

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

Treatment:

Dietary Supplement: Creatine Monohydrate

Dietary Supplement: Rice Flour

High dose

Experimental group

Description:

High dose of Creatine Monohydrate 20g/day (10g white rice flour) for the entire 28 day period

Treatment:

Dietary Supplement: Creatine Monohydrate

Dietary Supplement: Rice Flour