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Blood Flow Restriction and Creatine Supplementation in Women

Not Applicable
Completed
Conditions
Physical Inactivity
Interventions
Dietary Supplement: Creatine Monohydrate
Other: Exercise
Device: Blood Flow Restriction
Registration Number
NCT05877417
Lead Sponsor
University of Central Florida
Brief Summary

This research is examining the changes in muscle size, muscle function, body composition, strength, and blood vessel health. Specifically, the changes in these variables over the course of 8 weeks of training with or without blood flow restriction (BFR) and the supplementation of creatine or placebo (dextrose, a sugar in the form of a powder which is the standard placebo). Creatine monohydrate (Cr) is the most popular supplement for athletes and benefits all populations, however women are still very hesitant to take it due to the misconception of weight gain. This study will look to measure those muscle and body changes with exercise.

Detailed Description

We expect that you will be in this research study for an estimated 10 weeks, with 27 visits total. You will be asked to complete questionnaires, blood draws, and perform exercises using exercise machines for testing the strength of your legs while using a blood pressure cuff during some of these exercises. Other tests in this study will measure hydration (water in your system) status, your nervous system, and body composition percentage (bone/muscle tissue/fat tissue). Specifically, you will be asked to attend:

* 1 consent visit with familiarization (60min)

* 1 baseline assessment with a blood sample (60min)

* 1 baseline strength assessment (45min)

* 2 creatine supplementation loading day visits (15min)

* 1 post loading assessment with a blood sample (60min)

* 1 post loading strength assessment (45min)

* 16 training days (60min each) two of which will have blood samples (+70min)

* 1-4wk follow up assessment (45min)

* 1 4wk follow up strength assessment (45min)

* 1 posttest assessment (45min)

* 1 posttest strength assessment (45min)

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
68
Inclusion Criteria
  • Are female between the ages of 18 to 35
  • Recreationally active, defined as meeting the ACSM standards for recreationally active individuals of participating in physical activity ≥ 150 minutes exercise/week.
  • Not following a resistance training program
  • Are Not currently taking creatine monohydrate or have not taken it in the last 6 weeks
  • No known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease (i.e. heart failure, diabetes, COPD, etc.)
  • Do not regularly use prescription medication (not including contraceptives)
  • Are not currently seeking medical care.
  • Are not currently pregnant.
Exclusion Criteria
  • Taking creatine or has taken creatine in the last 6 weeks
  • Currently resistance training
  • Pregnant

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Creatine and Blood Flow Restriction ExerciseBlood Flow Restriction* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder.
Creatine and No-BFR with TrainingCreatine Monohydrate* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder.
Creatine and Blood Flow Restriction ExerciseCreatine Monohydrate* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder.
Placebo and Blood Flow Restriction ExerciseBlood Flow Restriction* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder.
Placebo and No-BFR with TrainingExercise* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder.
Primary Outcome Measures
NameTimeMethod
Body CompositionPre, 5-Days post loading, 4wk, 8wk

BIS, BodPod

Neuromuscular FunctionPre, 5-Days post loading, 4wk, 8wk

EMG

StrengthPre, 5-Days post loading, 4wk, 8wk

isokinetic dynanometer

Endothelial FunctionPre, 5-Days post loading, 4wk, 8wk

Flow Mediated Dilation

Secondary Outcome Measures
NameTimeMethod
Mood StatesPre, 5-Days post loading, 4wk, 8wk

Mood Assessed via administration of the POMS Questionnaire. 58 words or phrases are presented in a Likert format questionnaire reflecting how the subject feels at the time of completing the questionnaire. Scores range from 0 (Not at all) to 4 (Extremely). Tension, depression, anger, vigor, fatigue, confusion and total mood disturbance (TMD) will be measured.

Trial Locations

Locations (1)

University of Central Florida

🇺🇸

Orlando, Florida, United States

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