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NCT04731363 · ClinicalTrials.gov registry record · NA
Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion
A NA study of Cardiovascular Risk Factor, sponsored by The Cleveland Clinic.
- Active
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04731363: Active NA study of Cardiovascular Risk Factor, sponsored by The Cleveland Clinic.
NCT04731363 is a NA study of Cardiovascular Risk Factor that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 50 participants, below the 3,066-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04731363, a NA study of Cardiovascular Risk Factor, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measuring platelet function 30 minutes after polyol ingestion, using established in vitro platelet assays. Platelet aggregation responses, based on changes in light transmission after adding different concentrations of the agonists ADP and TRAP6 are reported. A higher percentage of light transmission indicates an increased aggregation response, with maximum amplitude (100%) indicating total aggregation.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT xylitol, 30g
- DIETARY_SUPPLEMENT erythritol, 30g
- DIETARY_SUPPLEMENT xylitol, 5g
- DIETARY_SUPPLEMENT glucose, 30g
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2025-12 |
| Phase | NA |
What the registry record for NCT04731363 still lists
NCT04731363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 3,066-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Cardiovascular Risk Factor appearing as the primary indexed condition, and to 4 interventions - of which xylitol, 30g is the first listed.
NCT04731363 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04731363 about?
NCT04731363 is a clinical study titled "Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion". 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 repla...
What is the current status of trial NCT04731363?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2021-03-10. Estimated completion is 2025-12.
What conditions does trial NCT04731363 study?
This clinical trial studies the following conditions: Cardiovascular Risk Factor.
What interventions are being tested in trial NCT04731363?
The interventions under investigation include: xylitol, 30g (DIETARY_SUPPLEMENT), erythritol, 30g (DIETARY_SUPPLEMENT), xylitol, 5g (DIETARY_SUPPLEMENT), glucose, 30g (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04731363?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04731363 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Risk Factor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04731363's enrollment target sits among peer trials
50 19th of 31 higher than 13 of 31 other Cardiovascular Risk Factor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Risk Factor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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