Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion
Artificial Sweeteners and Blood Clotting Risk
Plain English Summary
Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion is a Not Applicable clinical trial sponsored by The Cleveland Clinic studying Cardiovascular Risk Factor. This study investigates if common artificial sweeteners (xylitol and erythritol) affect blood platelets, which are involved in clotting. It is for adults, including those with Type 2 diabetes, who are not taking certain medications or have specific digestive conditions. Participants will drink a beverage containing an artificial sweetener or glucose and have blood samples taken. Alternatives include avoiding artificial sweeteners or discussing concerns with a doctor. The trial aims to enroll 50 participants.
Official 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
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and can give consent. You cannot join if you are taking blood-thinning medications, have an active infection, or have certain digestive issues like Crohn's disease. People with diabetes (Type 2) can join in a separate group. Pregnant individuals and those with significant chronic illnesses may not be eligible. This trial is studying Cardiovascular Risk Factor, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures will show if consuming artificial sweeteners changes how easily blood platelets stick together, which is a key factor in blood clot formation. The specific primary outcome measures are: Platelet Aggregation After Polyol Ingestion (30 minutes); Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion (Baseline and 30 minutes post ingestion of polyol intervention); Plasma Polyol Levels After Polyol Ingestion (30 minutes); Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion (Baseline and 30 minutes post ingestion of polyol intervention); Urinary Polyol Levels After Polyol Ingestion (30 minutes). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because artificial sweeteners are widely used as sugar substitutes, and this research could reveal potential risks to cardiovascular health by examining their effect on blood c This research targets Cardiovascular Risk Factor, where improved treatment options are needed.
Investor Insight
This trial addresses a growing concern about the health impacts of artificial sweeteners, a large market, and could influence consumer choices and regulatory guidelines.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially if you have any health conditions or take medications. You will need to drink a beverage and have blood drawn at specific times. You may need to avoid certain foods, medications, or supplements before and during the study. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 50 participants
Interventions
- DIETARY_SUPPLEMENT: xylitol, 30g — Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
- DIETARY_SUPPLEMENT: erythritol, 30g — Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
- DIETARY_SUPPLEMENT: xylitol, 5g — Intervention is a drink consisting of 300mL of water containing 5g of xylitol as a single oral dose.
- DIETARY_SUPPLEMENT: glucose, 30g — Intervention is a drink consisting of 300mL of water containing 30g of glucose (dextrose) as a single oral dose.
Primary Outcomes
- Platelet Aggregation After Polyol Ingestion (30 minutes)
- Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion (Baseline and 30 minutes post ingestion of polyol intervention)
- Plasma Polyol Levels After Polyol Ingestion (30 minutes)
- Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion (Baseline and 30 minutes post ingestion of polyol intervention)
- Urinary Polyol Levels After Polyol Ingestion (30 minutes)
Secondary Outcomes
- Change From Baseline in Plasma Lipid Profile at 1 Day Post Polyol Ingestion (Baseline and 1 day post ingestion of polyol intervention)
Full 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.
Trial Locations
- Cleveland Clinic, Cleveland, Ohio, United States
Frequently Asked Questions
What is clinical trial NCT04731363?
NCT04731363 is a Not Applicable INTERVENTIONAL study titled "Consumption of Oral Artificial Sweeteners on Platelet Aggregation and Polyol Excretion." It is currently active, not recruiting and is sponsored by The Cleveland Clinic. The trial targets enrollment of 50 participants.
What conditions does NCT04731363 study?
This trial investigates treatments for Cardiovascular Risk Factor. The primary condition under study is Cardiovascular Risk Factor.
What treatments are being tested in NCT04731363?
The interventions being studied include: xylitol, 30g (DIETARY_SUPPLEMENT), erythritol, 30g (DIETARY_SUPPLEMENT), xylitol, 5g (DIETARY_SUPPLEMENT), glucose, 30g (DIETARY_SUPPLEMENT). Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
What does Not Applicable mean for NCT04731363?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04731363?
This trial is currently "Active, Not Recruiting." It started on 2021-03-10. The estimated completion date is 2026-12.
Who is sponsoring NCT04731363?
NCT04731363 is sponsored by The Cleveland Clinic. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04731363?
The trial aims to enroll 50 participants. The trial status is active, not recruiting.
How is NCT04731363 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT04731363?
The primary outcome measures are: Platelet Aggregation After Polyol Ingestion (30 minutes); Change From Baseline in Platelet Aggregation at 30 Minutes Post Polyol Ingestion (Baseline and 30 minutes post ingestion of polyol intervention); Plasma Polyol Levels After Polyol Ingestion (30 minutes); Change From Baseline in Plasma Polyol Levels at 30 Minutes Post Polyol Ingestion (Baseline and 30 minutes post ingestion of polyol intervention); Urinary Polyol Levels After Polyol Ingestion (30 minutes). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04731363 being conducted?
This trial is being conducted at 1 site, including Cleveland, Ohio (United States).
Where can I find official information about NCT04731363?
The official record for NCT04731363 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04731363. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04731363 testing in simple terms?
This study investigates if common artificial sweeteners (xylitol and erythritol) affect blood platelets, which are involved in clotting. It is for adults, including those with Type 2 diabetes, who are not taking certain medications or have specific digestive conditions.
Why is this trial significant?
This trial is important because artificial sweeteners are widely used as sugar substitutes, and this research could reveal potential risks to cardiovascular health by examining their effect on blood c
What are the potential risks of participating in NCT04731363?
Potential risks include temporary discomfort from blood draws. Some participants might experience mild digestive upset. The long-term effects of consuming these sweeteners are still being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04731363?
Ask your doctor if this trial is right for you, especially if you have any health conditions or take medications. You will need to drink a beverage and have blood drawn at specific times. You may need to avoid certain foods, medications, or supplements before and during the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04731363 signal from an investment perspective?
This trial addresses a growing concern about the health impacts of artificial sweeteners, a large market, and could influence consumer choices and regulatory guidelines. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will drink a beverage containing an artificial sweetener or glucose and have blood samples taken. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.