Clinical trial NCT05877417: Blood Flow Restriction and Creatine Supplementation in Women
Official title: The Chronic Effects of Low-Load Blood Flow Restriction and Creatine Supplementation in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Keywords: creatine
blood flow restriction
exercise
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind placebo controlled
Primary purpose: BASIC_SCIENCE

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)

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

Primary outcomes:
measure: Strength
timeFrame: Pre, 5-Days post loading, 4wk, 8wk
measure: Body Composition
timeFrame: Pre, 5-Days post loading, 4wk, 8wk
measure: Neuromuscular Function
timeFrame: Pre, 5-Days post loading, 4wk, 8wk
measure: Endothelial Function
timeFrame: Pre, 5-Days post loading, 4wk, 8wk
Secondary outcomes:
measure: Mood States
timeFrame: Pre, 5-Days post loading, 4wk, 8wk
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Paola M Rivera
role: PRINCIPAL_INVESTIGATOR
References: