Skip to main content
Clinical Trials/NCT05877417
NCT05877417CompletedNot Applicable

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

University of Central Florida2 sites in 1 country68 target enrollmentStarted: May 17, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
68
Locations
2
Primary Endpoint
Body Composition

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Body Composition

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

BIS, BodPod

Neuromuscular Function

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

EMG

Strength

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

isokinetic dynanometer

Endothelial Function

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

Flow Mediated Dilation

Secondary Outcomes

  • Mood States(Pre, 5-Days post loading, 4wk, 8wk)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paola Rivera

PhD Candidate

University of Central Florida

Study Sites (2)

Loading locations...

Similar Trials

Blood Flow Restriction and Creatine... | Clinical Trial