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Creatine Supplementation for Endothelial Dysfunction (NOXCROS Trial)
N/A
Recruiting
Led By Paul Baker, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
Awards & highlights
NOXCROS Trial Summary
This trial looks at how an enzyme in the body and a sports supplement affect blood flow and cell function. Participants will compare the effects of a high-carb meal with and without the supplement.
Who is the study for?
This trial is for adults living near Tallahassee, Florida who are somewhat overweight (BMI of 25.0-34.9), don't exercise much, and haven't used creatine or antioxidant supplements recently. They shouldn't be on metabolism-affecting meds, pregnant, smoking, or have conditions like uncontrolled high blood pressure or diabetes.Check my eligibility
What is being tested?
The study tests how an enzyme (NOX) affects blood flow and if creatine supplementation improves it compared to a placebo. Participants will eat a high-carb meal before taking either creatine or placebo and then have their blood flow measured.See study design
What are the potential side effects?
Creatine may cause weight gain, muscle cramping, nausea, diarrhea and dehydration. The placebo (maltodextrin) could potentially affect blood sugar levels but generally has minimal side effects.
NOXCROS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from pre to post five days of creatine monohydrate supplementation at 0, 1, 2, 3, 4 hours post high carbohydrate meal
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentrations of reactive oxygen species (ROS)
Flow mediated dilation percentage
Rate of skeletal muscle blood flow
NOXCROS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Creatine Monohydrate SupplementationExperimental Treatment1 Intervention
Participants will be provided with 20 grams of creatine monohydrate per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of creatine monohydrate powder into water 4 times a day or 10 grams of creatine monohydrate powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.
Group II: Placebo (Maltodextrin)Placebo Group1 Intervention
Participants will be provided with 20 grams of maltodextrin (placebo) per day (100 grams total) in sealed and unopened packages (5 grams in each package). Participants will be asked to complete their supplementation protocol (20 grams/day) by mixing 5 grams of maltodextrin (placebo) into water 4 times a day or 10 grams of maltodextrin (placebo) powder into water twice a day. This supplementation will occur after a baseline visit in which participants consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial. Following the 5 days of supplementation participants will come back and consume a high-carb meal and have their vascular function studied before the meal and four hours post-prandial.
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Who is running the clinical trial?
Florida State UniversityLead Sponsor
200 Previous Clinical Trials
31,748 Total Patients Enrolled
2 Trials studying Endothelial Dysfunction
37 Patients Enrolled for Endothelial Dysfunction
Paul Baker, MSPrincipal InvestigatorFlorida State University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial offer any opportunities for volunteers to enroll?
"To be eligible for this clinical trial, applicants must possess endothelial dysfunction and fall within the 18-70 age range. This research is recruiting a maximum of 10 participants in total."
Answered by AI
Does this research include participants aged 75 and above?
"Adhering to the terms of this medical trial, participants must be at least 18 years old and no older than 70."
Answered by AI
How many participants have been chosen to partake in this experimental research?
"Affirmative. Clinicaltrials.gov data implies that this clinical trial, initially posted on August 29th 2023, is actively recruiting patients at present. 10 individuals will be accepted across 1 medical facility for participation in the study."
Answered by AI
Are there any remaining opportunities to participate in this trial?
"Affirmative. According to clinicaltrials.gov, this research is still actively recruiting participants since its inception on August 29th 2023 and last amendment on September 15th 2023. The researchers are looking for 10 individuals from a single site."
Answered by AI
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