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Creatine + Exercise for Sedentary Lifestyle
N/A
Recruiting
Research Sponsored by University of Central Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial investigates how muscle size, function, body composition, strength & blood vessel health change with exercise & supplementation w/ Creatine or placebo over 8 weeks. Women are hesitant to use Creatine, but this study looks to measure its effects.
Who is the study for?
This trial is for women aged 18-35 who lead a sedentary lifestyle, are not pregnant, don't use regular prescription meds (except contraceptives), and have no major health issues like heart disease or diabetes. Participants should be recreationally active but not engaged in resistance training or taking creatine recently.Check my eligibility
What is being tested?
The study tests how muscle size, function, body composition, strength, and blood vessel health change with an 8-week exercise program using either blood flow restriction (BFR) or normal methods. It also examines the effects of creatine supplementation versus a sugar placebo.See study design
What are the potential side effects?
Potential side effects may include discomfort from BFR during exercise and misconceptions about weight gain from creatine supplementation. However, actual side effects will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Composition
Endothelial Function
Neuromuscular Function
+1 moreSecondary outcome measures
Mood States
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Creatine and Blood Flow Restriction ExerciseExperimental Treatment2 Interventions
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.
Group II: Creatine and No-BFR with TrainingActive Control1 Intervention
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.
Group III: ControlActive Control1 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
Group IV: Placebo and Blood Flow Restriction ExercisePlacebo Group1 Intervention
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.
Group V: Placebo and No-BFR with TrainingPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Creatine Monohydrate
2009
Completed Phase 2
~170
Blood Flow Restriction
2022
N/A
~60
Find a Location
Who is running the clinical trial?
University of Central FloridaLead Sponsor
78 Previous Clinical Trials
1,097,401 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Creatine and No-BFR with Training
- Group 2: Control
- Group 3: Creatine and Blood Flow Restriction Exercise
- Group 4: Placebo and Blood Flow Restriction Exercise
- Group 5: Placebo and No-BFR with Training
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity to participate in this medical experiment?
"This trial is admitting 75 applicants, who must have an inactive lifestyle and be between 18-35 years old."
Answered by AI
Is eligibility for this clinical trial restricted by age, and if so, what are the upper limits?
"The target demographic for this clinical trial are individuals aged 18 to 35. Other trials may be available for those younger than 18 and older than 65, with 16 studies targeting the former age group and 64 research projects focusing on elderly patients."
Answered by AI
Are there still opportunities to participate in this experiment?
"This clinical experiment is actively searching for participants, as indicated on clinicaltrials.gov. It was first uploaded to the website on May 17th of 2023 and recently updated again that same day."
Answered by AI
How many participants are engaged in this experiment?
"Affirmative. Per the clinicaltrials.gov registry, this medical trial is actively looking for volunteers; it was first posted on May 17th 2023 and edited again that same day. The total recruitment size of this study is 75 patients from one site."
Answered by AI
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