Blood Flow Restriction and Creatine Supplementation in Women

NCT ID: NCT05877417

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2024-03-01

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)

Conditions

Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Creatine Monohydrate

Intervention Type: DIETARY_SUPPLEMENT

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

Blood Flow Restriction

Intervention Type: DEVICE

Blood Flow Restriction Cuffs applied during exercise

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.

Group Type: ACTIVE_COMPARATOR

Creatine Monohydrate

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Blood Flow Restriction

Intervention Type: DEVICE

Blood Flow Restriction Cuffs applied during exercise

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.

Group Type: SHAM_COMPARATOR

Exercise

Intervention Type: OTHER

Participants will exercise

Interventions

Creatine Monohydrate

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

Intervention Type: DIETARY_SUPPLEMENT

Blood Flow Restriction

Blood Flow Restriction Cuffs applied during exercise

Intervention Type: DEVICE

Exercise

Participants will exercise

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Central Florida

OTHER

Sponsor Role: lead

Responsible Party

Paola Rivera

PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paola M Rivera

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

University of Central Florida

Orlando, Florida, United States

Countries

United States

Other Identifiers

STUDY00005471

Identifier Type: -

Identifier Source: org_study_id