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Blood Flow Restriction and Creatine Supplementation in Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05877417
Enrollment
68
Registered
2023-05-26
Start date
2023-05-17
Completion date
2024-03-01
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Inactivity

Keywords

creatine, blood flow restriction, exercise

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)

Interventions

DIETARY_SUPPLEMENTCreatine Monohydrate

Creatine supplementation for 8 weeks, 5g daily. A 5 day loading phase will be implemented with 20g daily for 5 days.

DEVICEBlood Flow Restriction

Blood Flow Restriction Cuffs applied during exercise

OTHERExercise

Participants will exercise

Sponsors

University of Central Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

double blind placebo controlled

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
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 * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
StrengthPre, 5-Days post loading, 4wk, 8wkisokinetic dynanometer
Body CompositionPre, 5-Days post loading, 4wk, 8wkBIS, BodPod
Neuromuscular FunctionPre, 5-Days post loading, 4wk, 8wkEMG
Endothelial FunctionPre, 5-Days post loading, 4wk, 8wkFlow Mediated Dilation

Secondary

MeasureTime frameDescription
Mood StatesPre, 5-Days post loading, 4wk, 8wkMood 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026