NCT05967741NARecruitingAccepts Healthy Volunteers

The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

University of California, Davis

Start Date

7/20/2023

Completion Date

6/1/2026

Summary

The purpose is to conduct a dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for 2 weeks, in a randomized crossover design

Detailed Description

There is a strong correlation between plasma erythritol concentrations and adverse cardiovascular events in high risk individuals. It has also been demonstrated that consumption of dietary erythritol leads to high levels of plasma erythritol. There is in vitro evidence that erythritol at comparable concentrations promotes platelet activation. However, there is no direct evidence that links human consumption of erythritol with the onset of platelet activation and adhesion leading to inflammation. The investigators seek to fill this evidence gap by conducting a randomized crossover dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for two weeks.

Eligibility Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: * BMI ≥ 27 kg/m2 Exclusion Criteria: * • History of blood clot, transient ischemic attack (TIA), stroke, angina, heart attack, or peripheral vascular disease, or current cancer diagnosis. * Pregnant or lactating women * Current, prior (within 12 months), or anticipated use of medications for treatment of hyperlipidemia, high blood pressure or diabetes, or any medication that in the opinion of the investigators will confound results. * Unwilling to forego the use of anti-inflammatory medication during study. * Unwilling to forego the use of marijuana during the study. * Use of tobacco. * Strenuous exerciser (\>4 hours/week at a level more vigorous than walking). * Surgery or medication for weight loss. * Diet exclusions: Food allergies or dietary restrictions that may undermine compliance to dietary protocol, routine ingestion of more than 2 sugar-sweetened beverages or 2 alcoholic beverage/day. Unwillingness to consume artificial or noncaloric sweeteners. Habitual consumption (\>10 gram/day) of beverage or foods that contain erythritol. Recent or current weight loss diet.

Interventions

OTHER

Erythritol

OTHER

Aspartame

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Conditions

Platelet Aggregation, SpontaneousVascular Thrombosis

Locations

Ragle Human Nutrition Research Center, University of California, Davis

Davis, California 95616

United States