Blood Flow Restriction and Creatine Supplementation in Women

NCT05877417 | Completed FDA Device

• 1 other identifier: STUDY00005471
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity

Keywords

creatine; blood flow restriction; exercise

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Mood States

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

Study Arms (5)

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.

Dietary Supplement: Creatine Monohydrate; Device: Blood Flow Restriction

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.

Dietary Supplement: Creatine Monohydrate

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.

Device: Blood Flow Restriction

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.

Other: Exercise

Interventions

Creatine Monohydrate DIETARY_SUPPLEMENT

Creatine supplementation for 8 weeks, 5g daily. A 5 day loading phase will be implemented with 20g daily for 5 days.

Creatine and Blood Flow Restriction Exercise; Creatine and No-BFR with Training

Blood Flow Restriction DEVICE

Blood Flow Restriction Cuffs applied during exercise

Creatine and Blood Flow Restriction Exercise; Placebo and Blood Flow Restriction Exercise

Exercise OTHER

Participants will exercise

Placebo and No-BFR with Training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Taking creatine or has taken creatine in the last 6 weeks
• Currently resistance training
• Pregnant

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Interventions

Creatine; Blood Flow Restriction Therapy; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paola M Rivera

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: double blind placebo controlled

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: May 17, 2023
• Primary Completion: December 20, 2023
• Study Completion: March 1, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)