Summary

Eligibility
for people ages 18-70 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study start
estimated completion

Description

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

Official Title

Randomized Controlled Clinical Trial to Gauge the Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

Details

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.

Keywords

Platelet Aggregation, Spontaneous, Vascular Thrombosis, platelet activation, vascular inflammation, erythritol, aspartame, dietary intervention, Thrombosis, Inflammation, Erythritol-sweetened beverage, Aspartame-sweetened beverage

Eligibility

You can join if…

Open to people ages 18-70

- BMI ≥ 27 kg/m2

You CAN'T join if...

  • • 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.

Location

  • Ragle Human Nutrition Research Center, University of California, Davis accepting new patients
    Davis California 95616 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT05967741
Study Type
Interventional
Participants
Expecting 24 study participants
Last Updated