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Polyol
Oral Artificial Sweeteners for Cardiovascular Risk (COSETTE Trial)
N/A
Waitlist Available
Led By Wilson Tang, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or above.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
COSETTE Trial Summary
This trial will test whether a drink containing the artificial sweeteners erythritol or xylitol alters in vitro platelet aggregation.
Who is the study for?
This trial is for adults over 18 who can consent to participate. It's not suitable for those with a history of bariatric surgery, pregnant individuals, people on anti-platelet meds recently, anyone with an active infection or recent antibiotics use, diabetics, and those with chronic gastrointestinal disorders or significant chronic illness.Check my eligibility
What is being tested?
The study tests if drinks containing artificial sweeteners (erythritol or xylitol) affect platelet aggregation—a factor in cardiovascular risk. Participants will consume beverages with different amounts of these sweeteners to see how they impact blood sugar alcohol levels and platelet activity.See study design
What are the potential side effects?
While the trial itself may not have direct side effects from the interventions since it involves common food additives at varying doses, potential indirect effects could include digestive discomfort due to the body's response to high amounts of sugar alcohols.
COSETTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
COSETTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
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 Plasma Polyol levels at 30 minutes Post Polyol Ingestion
Change from Baseline in Platelet Aggregation at 30 minutes Post Polyol Ingestion
Change from Baseline in Urinary Polyol Levels at 30 minutes Post Polyol Ingestion
+3 moreSecondary outcome measures
Change from Baseline in Plasma Lipid Profile at 30 minutes Post Polyol Ingestion
COSETTE Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Xylitol, 5gExperimental Treatment1 Intervention
oral xylitol, a potent artificial sweetener
Group II: Xylitol, 30gExperimental Treatment1 Intervention
oral xylitol, a potent artificial sweetener
Group III: Erythritol, 30gExperimental Treatment1 Intervention
oral erythritol, a potent artificial sweetener
Group IV: Glucose, 30gActive Control1 Intervention
oral glucose, delivered as dextrose
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,026 Total Patients Enrolled
3 Trials studying Cardiovascular Risk
236 Patients Enrolled for Cardiovascular Risk
Wilson Tang, MD5.05 ReviewsPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
5 Previous Clinical Trials
2,190 Total Patients Enrolled
5Patient Review
This medical professional is excellent. They take the time to make sure you understand your condition and treatment options. They are also a great resource if you have questions. I would highly recommend this doctor.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken any over-the-counter probiotics in the last month.I have a long-term gut condition like ulcerative colitis or Crohn's disease.I have had weight loss surgery in the past.I am 18 years old or older.You have a long-term health condition that requires ongoing medical attention.I have not taken anti-platelet medications in the last 14 days.I have not had an infection or taken antibiotics in the last month.I have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Glucose, 30g
- Group 2: Xylitol, 30g
- Group 3: Erythritol, 30g
- Group 4: Xylitol, 5g
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What is the current enrollment rate of this clinical trial?
"Affirmative, the clinicaltrials.gov database reveals that this medical experiment is enlisting participants. The trial was first announced on March 10th 2021 and has been revised most recently on May 4th 2022. This venture requires 40 volunteers from one location to take part in it."
Answered by AI
Are volunteers being sought to participate in this experiment currently?
"Clinicaltrials.gov affirms that this medical experiment is recruiting participants, having first appeared on the site on March 10th 2021 and subsequently edited May 4th 2022."
Answered by AI
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