The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation (EASI)

University of California (UC) Davis

Status: Enrolling

Conditions: Vascular Thrombosis; Platelet Aggregation, Spontaneous

Treatments: Other: Erythritol; Other: Aspartame

Study type: Interventional

Funder types: Other

Identifiers

NCT05967741

2030510

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Erythritol-sweetened beverage

Experimental group

Description:

1-gram erythritol/kg body weight/day, divided into three beverage servings and fruit-flavored with Kool-Aid® unsweetened drink mix.

Treatment:

Other: Erythritol

Aspartame-sweetened beverage

Placebo Comparator group

Description:

Control beverages will be made from a noncaloric aspartame-sweetened, fruit-flavored drink mix at the concentration needed to match the sweetness (\~3 mg aspartame/kg/day) and flavoring of the erythritol beverages on a per volume basis.

Treatment:

Other: Aspartame