Blood Flow Restriction and Creatine Supplementation in Women

The Chronic Effects of Low-Load Blood Flow Restriction and Creatine Supplementation in Women

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.

Study Overview

• Status: Completed
• Conditions: Physical Inactivity
• Intervention / Treatment: Dietary supplement: Creatine Monohydrate; Device: Blood Flow Restriction; Other: 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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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
Experimental: Creatine and Blood Flow Restriction Exercise; 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.	Dietary supplement: Creatine Monohydrate; Creatine supplementation for 8 weeks, 5g daily. A 5 day loading phase will be implemented with 20g daily for 5 days.; Device: Blood Flow Restriction; Blood Flow Restriction Cuffs applied during exercise
Active Comparator: Creatine and No-BFR with Training; 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.	Dietary supplement: Creatine Monohydrate; Creatine supplementation for 8 weeks, 5g daily. A 5 day loading phase will be implemented with 20g daily for 5 days.
Placebo Comparator: Placebo and Blood Flow Restriction Exercise; 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.	Device: Blood Flow Restriction; Blood Flow Restriction Cuffs applied during exercise
Sham Comparator: Placebo and No-BFR with Training; 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.	Other: Exercise; Participants will exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	isokinetic dynanometer	Pre, 5-Days post loading, 4wk, 8wk
Body Composition	BIS, BodPod	Pre, 5-Days post loading, 4wk, 8wk
Neuromuscular Function	EMG	Pre, 5-Days post loading, 4wk, 8wk
Endothelial Function	Flow Mediated Dilation	Pre, 5-Days post loading, 4wk, 8wk

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood States	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.	Pre, 5-Days post loading, 4wk, 8wk

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Paola M Rivera, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: exercise; blood flow restriction; creatine
• Other Study ID Numbers: STUDY00005471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes