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Completed
NCT04731363
Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion
Conditions: Cardiovascular Risk Factor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
Summary
The principal goal for the study is to examine whether ingestion of a beverage containing artificial sweeteners alters in vitro platelet aggregation.
Because of the increasing number of cardiometabolic diseases, such as diabetes mellitus, in the population, the use of artificial sweeteners to replace free sugars has been gaining popularity. Two popular artificial sweeteners are erythritol and xylitol. Erythritol and xylitol are both naturally occurring polyols found in fruits and vegetables. They are potent artificial sweeteners with a higher sweetening intensity and lower calorie content than table sugar.
Previous research has shown that the higher levels of sugar alcohols, like those used as artificial sweeteners, in the blood are related to a higher risk of cardiovascular complications, like heart attacks and strokes, and death. This may be because higher levels of sugar alcohols in one's blood may increase the activity of platelets, which would then increase the risk of heart attack and stroke. The investigators therefore want to find if consuming a single beverage that contains an artificial sweetener can raise the levels of sugar alcohols in the blood and if it can alter platelet function or aggregation.
Eligibility Criteria
Cohort 1 Inclusion Criteria:
* Age 18 years or above.
* Willing and able to sign the consent form.
Cohort 1 Exclusion Criteria:
* Use of anti-platelet medications within 14 days of study enrollment.
* Active infection or received antibiotics within 1 month of study enrollment.
* Use of over-the-counter probiotic within 1 month of study enrollment.
* Diabetes mellitus
* Ulcerative colitis, Crohn's disease, or other chronic gastrointestinal disorder.
* Past history of bariatric procedures or surgeries (e.g. gastric banding or bypass).
* Pregnancy.
* Significant chronic illness.
Cohort 2 Inclusion Criteria:
* Men and women age 18 years or above.
* Able to provide informed consent and comply with study protocol.
* Diabetes Mellitus Type II
Cohort 2 Exclusion Criteria:
* Use of anti-platelet medications within 14 days of study enrollment.
* Active infection or received antibiotics within 1 month of study enrollment.
* Use of over-the-counter probiotic within 1 month of study enrollment.
* Ulcerative colitis, Crohn's disease, or other chronic gastrointestinal disorder.
* Past history of bariatric procedures or surgeries (e.g. gastric banding or bypass).
* Pregnancy.
* Any condition that, in the judgment of the Investigator, would place a subject at undue risk by being enrolled in the trial or cause inability to comply with the trial.
Source: ClinicalTrials.gov (NCT04731363). StuddyBuddy aggregates publicly available trial information.