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Dietary Supplement
Creatine monohydrate for Endothelial Dysfunction
N/A
Waitlist Available
Led By Holly E Clarke, MS
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
both male and female
50-64 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 4
Awards & highlights
Study Summary
This trial looks at the effects of taking creatine for 4 weeks on various measures of physical and cognitive performance, as well as markers of micro- and macrovascular function.
Eligible Conditions
- Endothelial Dysfunction
- Stress Oxidative
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in augmentation (AUG) and augmentation index (AIx) using pulse wave analysis (PWA) at week 4
Structure of brachial artery
Change from baseline in brachial-ankle pulse wave velocity (baPWV) at week 4
+8 moreSecondary outcome measures
Change from baseline in body fat mass (grams) at week 4
Change from baseline in body fat percent (BF%) at week 4
Change from baseline in body lean mass (grams) at week 4
+3 moreSide effects data
From 2015 Phase 4 trial • 14 Patients • NCT0151463071%
Cold and flu symptoms
29%
Diarrhea
21%
Stomach Discomfort
14%
Muscle Cramps
7%
Lightheaded
7%
Headache
7%
Nausea
7%
Indigestion
7%
Polydipsia
7%
Swelling in Hands
7%
Numbness and Tingling in hands
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creatine Monohydrate
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Creatine monohydrateExperimental Treatment1 Intervention
Participants received 4 x 5g doses of creatine monohydrate (powdered form) for 5 days, followed by 1 x 5g doses of creatine monohydrate (powdered form) for 23 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants received 4 x 5g doses of placebo (powdered Maltodextrin) for 5 days, followed by 1 x 5g doses of placebo (powdered Maltodextrin) for 23 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Creatine monohydrate
2005
Completed Phase 4
~620
Find a Location
Who is running the clinical trial?
Florida State UniversityLead Sponsor
197 Previous Clinical Trials
30,628 Total Patients Enrolled
2 Trials studying Endothelial Dysfunction
35 Patients Enrolled for Endothelial Dysfunction
Holly E Clarke, MSPrincipal InvestigatorFlorida State University
Holly E Clarke, PhDPrincipal InvestigatorFlorida State University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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