The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
Purpose
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
Conditions
- Platelet Aggregation, Spontaneous
- Vascular Thrombosis
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Randomized crossover study with 2-week washout
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
- Masking Description
- Experimental and control beverage are formulated to be similar color, taste and volume.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Erythritol-sweetened beverage |
1-gram erythritol/kg body weight/day, divided into three beverage servings and fruit-flavored with Kool-Aid® unsweetened drink mix. |
|
|
Placebo Comparator Aspartame-sweetened beverage |
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. |
|
Recruiting Locations
Davis 5341704, California 5332921 95616
More Details
- Status
- Recruiting
- Sponsor
- University of California, Davis
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.