Status:
RECRUITING
The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
Lead Sponsor:
University of California, Davis
Conditions:
Platelet Aggregation, Spontaneous
Vascular Thrombosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- BMI ≥ 27 kg/m2
Exclusion
- • 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.
Key Trial Info
Start Date :
July 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05967741
Start Date
July 20 2023
End Date
June 1 2026
Last Update
December 5 2025
Active Locations (1)
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1
Ragle Human Nutrition Research Center, University of California, Davis
Davis, California, United States, 95616