Measuring Uniformed Servicemembers' Fitness Scores on Creatine Loading and Exercise

NCT ID: NCT02661334

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2018-02-13

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.

Conditions

Physical Fitness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo

30g white rice flour

Group Type: PLACEBO_COMPARATOR

Rice Flour

Intervention Type: DIETARY_SUPPLEMENT

rice flour powder matched for color, appearance, taste, and solubility

Low dose

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

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DIETARY_SUPPLEMENT

Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace

Rice Flour

Intervention Type: DIETARY_SUPPLEMENT

rice flour powder matched for color, appearance, taste, and solubility

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

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DIETARY_SUPPLEMENT

Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace

Rice Flour

Intervention Type: DIETARY_SUPPLEMENT

rice flour powder matched for color, appearance, taste, and solubility

High dose

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

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DIETARY_SUPPLEMENT

Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace

Rice Flour

Intervention Type: DIETARY_SUPPLEMENT

rice flour powder matched for color, appearance, taste, and solubility

Interventions

Creatine Monohydrate

Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace

Intervention Type: DIETARY_SUPPLEMENT

Rice Flour

rice flour powder matched for color, appearance, taste, and solubility

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

David Grant U.S. Air Force Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen D Kasteler, MD

Role: PRINCIPAL_INVESTIGATOR

US Air Force

Locations

David Grant Medical Center

Fairfield, California, United States

Countries

United States

Other Identifiers

FDG20150021H

Identifier Type: -

Identifier Source: org_study_id