NCT05877417CompletedNot Applicable
The Chronic Effects of Low-Load Blood Flow Restriction and Creatine Supplementation in Women
University of Central Florida1 site in 1 country68 target enrollmentStarted: May 17, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Body Composition
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
No Intervention
If you are in the control group, there will be no supplement or exercise procedures.
You will be asked to come in to the lab for 5 visits
Creatine and Blood Flow Restriction Exercise
Experimental
- 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.
Intervention: Blood Flow Restriction (Device)
Placebo and Blood Flow Restriction Exercise
Placebo Comparator
- 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.
Intervention: Blood Flow Restriction (Device)
Placebo and No-BFR with Training
Sham Comparator
- 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.
Intervention: Exercise (Other)
Creatine and No-BFR with Training
Active Comparator
- 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.
Intervention: Creatine Monohydrate (Dietary Supplement)
Creatine and Blood Flow Restriction Exercise
Experimental
- 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.
Intervention: Creatine Monohydrate (Dietary Supplement)
Outcomes
Primary Outcomes
Body Composition
Time Frame: Pre, 5-Days post loading, 4wk, 8wk
BIS, BodPod
Neuromuscular Function
Time Frame: Pre, 5-Days post loading, 4wk, 8wk
EMG
Strength
Time Frame: Pre, 5-Days post loading, 4wk, 8wk
isokinetic dynanometer
Endothelial Function
Time Frame: Pre, 5-Days post loading, 4wk, 8wk
Flow Mediated Dilation
Secondary Outcomes
- Mood States(Pre, 5-Days post loading, 4wk, 8wk)
Investigators
Paola Rivera
PhD Candidate
University of Central Florida
Study Sites (1)
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