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Completed

NCT Number: NCT05877417

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.

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Key information

Conditions

Physical Inactivity Behavior Motor Activity Sedentary Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Blood Flow Restriction

Device

Blood Flow Restriction Cuffs applied during exercise

Exercise

Other

Participants will exercise

Primary outcomes

  1. Strength

    Time frame: Pre, 5-Days post loading, 4wk, 8wk

    isokinetic dynanometer

  2. Body Composition

    Time frame: Pre, 5-Days post loading, 4wk, 8wk

    BIS, BodPod

  3. Neuromuscular Function

    Time frame: Pre, 5-Days post loading, 4wk, 8wk

    EMG

  4. Endothelial Function

    Time frame: Pre, 5-Days post loading, 4wk, 8wk

    Flow Mediated Dilation

Secondary outcomes

  1. Mood States

    Time frame: Pre, 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.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 26, 2023
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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