Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion (NCT04731363) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion
United States50 participantsStarted 2021-03-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Platelet Aggregation After Polyol Ingestion
Timeframe: 30 minutes
2
Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion
Timeframe: Baseline and 30 minutes post ingestion of polyol intervention
3
Plasma Polyol Levels After Polyol Ingestion
Timeframe: 30 minutes
4
Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion
Timeframe: Baseline and 30 minutes post ingestion of polyol intervention
5
Urinary Polyol Levels After Polyol Ingestion
Timeframe: 30 minutes
6
Change From Baseline in Urinary Polyol Levels at 30 Minutes Post Polyol Ingestion
Timeframe: Baseline and 30 minutes post ingestion of polyol intervention