Blood Flow Restriction and Creatine Supplementation in Women

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05877417
• Other study ID #: STUDY00005471
• Status: Completed
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2024
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 1, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

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

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength	isokinetic dynanometer	Pre, 5-Days post loading, 4wk, 8wk
Primary	Body Composition	BIS, BodPod	Pre, 5-Days post loading, 4wk, 8wk
Primary	Neuromuscular Function	EMG	Pre, 5-Days post loading, 4wk, 8wk
Primary	Endothelial Function	Flow Mediated Dilation	Pre, 5-Days post loading, 4wk, 8wk
Secondary	Mood States	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.	Pre, 5-Days post loading, 4wk, 8wk