Blood Flow Restriction and Creatine Supplementation in Women

Not Applicable

Completed

• Conditions: Physical Inactivity

• Registration Number: NCT05877417
• Lead Sponsor: University of Central Florida

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 Timeline

• Study Start: 2023-05-17
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-26
• Primary Completion: 2023-12-20
• Study Completion: 2024-03-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mood States	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.

Trial Locations

Locations (1)

University of Central Florida; 🇺🇸 Orlando, Florida, United States