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

University of California (UC) Davis logo

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

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

Trial contacts and locations

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Central trial contact

Marinelle Nunez, B.S.; Kimber L. Stanhope, Ph.D.

Data sourced from clinicaltrials.gov

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