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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05451498
Other study ID # Protocol #2021-28
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2022
Est. completion date May 5, 2022

Study information

Verified date July 2022
Source Rocky Mountain University of Health Professions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

While the use of creatine monohydrate supplementation and its associated benefits are well researched and supported, the impact of the timing of when creatine is ingested is a highly nuanced topic. The potential for the timing of administration to make an impact on observed outcomes is an established and appreciated factor and limited research to date has examined the impact of creatine timing. Of the literature that has been published, one study was very short in duration (4 weeks) that possessed a study design that undermined its practicality, two other studies used older individuals, and one study utilized a unilateral training model which may not be an adequate exercise protocol to allow for the ergogenic potential of creatine to mediate any enhancement of training adaptations. Therefore, based on the limited number of studies in young and previously trained populations, future studies examining the effects of pre vs post-training creatine monohydrate supplementation on resistance training adaptations are warranted.


Description:

In a randomized, double-blind, placebo-controlled, parallel design, eligible study participants were provided a daily dose of creatine monohydrate (pre-or post-workout) or placebo (no creatine delivered) for an 8-week supplementation period. Based upon their baseline fat-free mass, participants were randomized into one of three groups: pre-workout creatine supplementation (PRE), post-workout creatine supplementation (POST), or placebo (PLA). Each group consumed their assigned dose or placebo within one hour before exercise and within one hour following exercise. Each assigned supplement was consumed with 12-16 ounces of fluid along with a 25-gram dose of whey protein isolate and a 25-gram dose of carbohydrate powder This additional supplementation was provided to aid in blinding and to help ensure adequate dietary protein intake was provided to promote increases in lean body mass and strength. Providing daily doses of carbohydrates and protein also helped with recruitment efforts as all study participants received some efficacious nutrients. All participants completed a twelve-week resistance training and conditioning program. The first four weeks of resistance training (12 workouts) occurred before supplementation began and were completed to acclimate participants to the program and to initiate early neuromuscular adaptations commonly seen with starting a new resistance training program. In addition, this initial 4-week period allowed for some study participants to wash out from ongoing supplementation prior to beginning the supplementation protocol. After completion of this run-in period, participants then completed baseline testing as described and began the supplementation protocol while continuing to follow the resistance training program for an additional eight weeks. Before and after the 8-week supplementation and resistance training period, body mass, body water, and body composition were assessed in addition to changes in muscular strength, muscular endurance, and lower-body power. All statistical analysis was completed on data collected starting at the beginning and end of the supplementation period. Participants were provided nutritional recommendations in order to ensure adequate energy and protein consumption to facilitate positive training adaptations and reduce the potential influence of differing dietary intakes.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date May 5, 2022
Est. primary completion date May 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 30 Years
Eligibility Inclusion Criteria: - At least 19 years of age but less than 30 years of age. - Current member of Midland University athletic team completing off-season resistance training program. - Participants will be healthy as determined by evaluation of medical history and if they are cleared to participate in their sport, they are cleared to participate in the study (as deemed by the team medical provider i.e. Certified Athletic Trainer). Exclusion Criteria: - As indicated on a medical history form they complete, any individual who is currently being treated or is diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic obesity (defined as body mass index >35 kg/m2 and body fat greater than 30%), immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder or disease will be excluded. - Individuals with allergies to milk or soy (lecithin). - For females only, if they are currently pregnant or become pregnant at any point throughout the study.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Creatine
Participants were matched according to fat-free mass to consume a placebo, or 5-g dose of creatine monohydrate within one hour before training, or within one hour after training for 8 weeks while completing a weekly resistance training program. At each time point (before and after training), all participants co-ingested a 25-gram dose whey isolate and a 25-gram dose of carbohydrate powder along with their assigned supplement. Body composition using a 3-compartment field (3CFIELD), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF] at 80% 1RM) using bench press (BP) and back squat (SQ) exercises along with isometric mid-thigh pull (IMTP) were assessed before and after the 8-week supplementation period.
Maltodextrin
Participants were matched according to fat-free mass to consume a placebo (maltodextrin) within one hour before training, or within one hour after training for 8 weeks while completing a weekly resistance training program. At each time point (before and after training), all participants co-ingested a 25-gram dose whey isolate and a 25-gram dose of carbohydrate powder along with their assigned supplement. Body composition using a 3-compartment field (3CFIELD), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF] at 80% 1RM) using bench press (BP) and back squat (SQ) exercises along with isometric mid-thigh pull (IMTP) were assessed before and after the 8-week supplementation period.

Locations

Country Name City State
United States Rocky Mountain University of Health Professions Provo Utah

Sponsors (4)

Lead Sponsor Collaborator
Rocky Mountain University of Health Professions Lindenwood University, Mayo Clinic, Western Michigan University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat-Free Mass 3-compartment field (3CFIELD) 8 weeks
Primary Lower Body Strength Back Squat 1 repetition maximum according to standard protocols 8 weeks
Secondary Fat Mass 3-compartment field (3CFIELD) 8 weeks
Secondary Body Fat Percentage 3-compartment field (3CFIELD) 8 weeks
Secondary Total Body Water Determined by bioelectrical impedance spectroscopy 8 weeks
Secondary Upper Body Strength Bench Press 1 repetition maximum according to standard protocols 8 weeks
Secondary Lower Body Muscular Endurance 80% 1 RM Back Squat repetitions to fatigue 8 weeks
Secondary Upper Body Muscular Endurance 80% 1 RM Bench press repetitions to fatigue 8 weeks
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