NCT02661334

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2018

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

December 7, 2015

Last Update Submit

April 1, 2020

Conditions

Physical Fitness

Keywords

creatinecreatine monohydratesupplementexercisefitness

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (5)

  • 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.

    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.

    28 days

  • Evaluate the risk of rhabdomyolysis with creatine supplementation by measuring creatine kinase before and after the study period.

    28 days

  • Treatment compliance as determined by medication diary.

    28 days

  • Quality of workout as determined by exercise diary.

    28 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

30g white rice flour

Dietary Supplement: Rice Flour

Low dose

EXPERIMENTAL

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

Dietary Supplement: Creatine MonohydrateDietary Supplement: Rice Flour

Loading dose

EXPERIMENTAL

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

Dietary Supplement: Creatine MonohydrateDietary Supplement: Rice Flour

High dose

EXPERIMENTAL

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

Dietary Supplement: Creatine MonohydrateDietary Supplement: Rice Flour

Interventions

Creatine MonohydrateDIETARY_SUPPLEMENT

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

High doseLoading doseLow dose
Rice FlourDIETARY_SUPPLEMENT

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

High doseLoading doseLow dosePlacebo

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Grant Medical Center

Fairfield, California, 94535, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

CreatineFlour

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stephen D Kasteler, MD

    US Air Force

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

January 22, 2016

Study Start

August 1, 2015

Primary Completion

February 13, 2018

Study Completion

February 13, 2018

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)