NCT05877417

Blood Flow Restriction and Creatine Supplementation in Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Central Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
OTHER	Exercise	Participants will exercise

Timeline

• Start date: 2023-05-17
• Primary completion: 2023-12-20
• Completion: 2024-03-01
• First posted: 2023-05-26
• Last updated: 2024-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study