Physical InactivityNCT05877417
Blood Flow Restriction and Creatine Supplementation in Women
A study testing Creatine Monohydrate, Blood Flow Restriction and Exercise in people with Physical Inactivity, run by University of Central Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Creatine Monohydrate, Blood Flow Restriction and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Taking creatine or has taken creatine in the last 6 weeks
- Currently resistance training
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: The Chronic Effects of Low-Load Blood Flow Restriction and Creatine Supplementation in Women
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.
Read the 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
- Being tested
- Creatine Monohydrate, Blood Flow Restriction, Exercise
- Keywords
- creatine, blood flow restriction, exercise
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Creatine supplementation for 8 weeks, 5g daily. A 5 day loading phase will be implemented with 20g daily for 5 days.
Blood Flow RestrictionDevice
Blood Flow Restriction Cuffs applied during exercise
ExerciseOther
Participants will exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | If you are in the control group, there will be no supplement or exercise procedures. You will be asked to come in to the lab for 5 visits |
| Creatine and Blood Flow Restriction Exercise | Experimental | * Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures.
* Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement.
* If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group.
* The supplement and placebo are flavorless and odorless powder. Receives: Dietary Supplement: Creatine Monohydrate; Device: Blood Flow Restriction |
| Creatine and No-BFR with Training | Active comparator | * Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures.
* Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement.
* If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group.
* The supplement and placebo are flavorless and odorless powder. Receives: Dietary Supplement: Creatine Monohydrate |
| Placebo and Blood Flow Restriction Exercise | Placebo comparator | * Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures.
* Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement.
* If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group.
* The supplement and placebo are flavorless and odorless powder. Receives: Device: Blood Flow Restriction |
| Placebo and No-BFR with Training | Sham comparator | * Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures.
* Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement.
* If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group.
* The supplement and placebo are flavorless and odorless powder. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
isokinetic dynanometer
Measured: Pre, 5-Days post loading, 4wk, 8wk
Body Composition
BIS, BodPod
Measured: Pre, 5-Days post loading, 4wk, 8wk
Neuromuscular Function
EMG
Measured: Pre, 5-Days post loading, 4wk, 8wk
Endothelial Function
Flow Mediated Dilation
Measured: Pre, 5-Days post loading, 4wk, 8wk
Secondary outcomes (1)
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.
Measured: Pre, 5-Days post loading, 4wk, 8wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start17 May 2023
- Primary completion20 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Rivera, University of Central Florida
- Investigators
- Paola M Rivera, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877417
- Sponsor's protocol ID
- STUDY00005471
- Status last verified
- Jun 2024
- First submitted
- 17 May 2023
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Effects of Low-Load Blood Flow Restriction and Creatine Supplementation in Women
- ClinicalTrials.gov ID
- NCT05877417
- Acronym / sponsor ID
- STUDY00005471
- Conditions
- Physical Inactivity
- Keywords
- creatine, blood flow restriction, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- double blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –If you are in the control group, there will be no supplement or exercise procedures. You will be asked to come in to the lab for 5 visits |
| Creatine and Blood Flow Restriction Exercise | Experimental | Dietary Supplement: Creatine Monohydrate, Device: Blood Flow Restriction* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder. |
| Creatine and No-BFR with Training | Active comparator | Dietary Supplement: Creatine Monohydrate* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder. |
| Placebo and Blood Flow Restriction Exercise | Placebo comparator | Device: Blood Flow Restriction* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder. |
| Placebo and No-BFR with Training | Sham comparator | Other: Exercise* Of the other four groups, regardless of randomization, all 4 groups will be supplementing the same for the loading phase and throughout the study. Since this study is blinded, the research personnel will not know which supplement you are given and will therefore ensure everyone is following the same procedures. * Loading here means to consume more than the daily amount of supplement. This visit will have participants consume 5g twice in one day and twice more at home. This is a normal practice and standard use of the supplement. * If you are not in the control group, you will further be randomized into one of four possible supplementation groups. These groups will be double blinded and randomized into either placebo or creatine supplementation. Creatine monohydrate powder (Muscle Feast, Creapure®) will be used for the active supplement group. Dextrose powder (sugar) will be used for the placebo group. * The supplement and placebo are flavorless and odorless powder. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.)
Key exclusion criteria (3 listed)
- Taking creatine or has taken creatine in the last 6 weeks
- Currently resistance training
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine MonohydrateCreatine supplementation for 8 weeks, 5g daily. A 5 day loading phase will be implemented with 20g daily for 5 days. | Dietary supplement | Creatine and Blood Flow Restriction Exercise, Creatine and No-BFR with Training |
| Blood Flow RestrictionBlood Flow Restriction Cuffs applied during exercise | Device | Creatine and Blood Flow Restriction Exercise, Placebo and Blood Flow Restriction Exercise |
| ExerciseParticipants will exercise | Other | Placebo and No-BFR with Training |
Primary outcome
Strength
Time frame: Pre, 5-Days post loading, 4wk, 8wk
isokinetic dynanometer
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
Endothelial Function
Time frame: Pre, 5-Days post loading, 4wk, 8wk
Flow Mediated Dilation
1 secondary outcome
Mood States
Time frame: Pre, 5-Days post loading, 4wk, 8wk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Physical Inactivity
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola M Rivera principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate, Blood Flow Restriction and Exercise in people with Physical Inactivity, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: Pre, 5-Days post loading, 4wk, 8wk). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.