Randomized Controlled Clinical Trial to Gauge the Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Platelet Aggregation, Spontaneous
- Sponsor
- University of California, Davis
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Platelet aggregation in response to physiologic agonist, assessed as aggregation/min
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Platelet aggregation in response to physiologic agonist, assessed as aggregation/min
Time Frame: 6 weeks
The change in aggregation/min induced by physiologic agonists will be measured by light transmission aggregometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
Platelet-leukocyte interaction, assessed as platelet/leukocyte aggregate size by fluorescence mean intensity
Time Frame: 6 weeks
Change in platelet/leukocyte aggregate size, an index of platelet-leukocyte interaction, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
P-selectin, a platelet surface marker, assessed as percentage of P-selectin positive cells
Time Frame: 6 weeks
Change in percentage of P-selectin positive cells, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as median fluorescence intensity
Time Frame: 6 weeks
Change in median fluorescence intensity of PAC-1, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
PAC-1 (GPIIb/IIIa complex), a platelet surface marker, assessed as percentage of PAC-1 positive cells
Time Frame: 6 weeks
Change in percentage of PAC-1 positive cells, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
P-selectin, a platelet surface marker, assessed as median fluorescence intensity
Time Frame: 6 weeks
Change in median fluorescence intensity of P-selectin, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
Annexin V, a platelet surface marker, assessed as percentage of annexin V positive cells
Time Frame: 6 weeks
Change in percentage of annexin V positive cells, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
Platelet reactivity to physiologic agonist, assessed as change in median fluorescence intensity
Time Frame: 6 weeks
The change in median fluorescence intensity induced by physiologic agonists, an index of platelet reactivity, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
Annexin V, a platelet surface marker, assessed as median fluorescence intensity
Time Frame: 6 weeks
Change in median fluorescence intensity of annexin V, an index of platelet activation, will be measured by flow cytometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
Platelet aggregation in response to physiologic agonist, assessed as percent of maximum aggregation
Time Frame: 6 weeks
The change in % maximum aggregation induced by physiologic agonists will be measured by light transmission aggregometry in whole blood collected from subjects before and after consuming erythritol-sweetened beverage for 2 weeks and compared with change in whole blood collected before and after consuming aspartame-sweetened beverage for 2 weeks
Secondary Outcomes
- Plasma concentration of sICAM1(6 weeks)
- Plasma concentration of E-Selectin(6 weeks)
- Plasma concentration of sVCAM1(6 weeks)
- Plasma concentration of D-dimer(6 weeks)
- Plasma concentration of Fibrinogen(6 weeks)
- Plasma concentration of Platelet factor 4(6 weeks)
- Plasma concentration of Prothrombin fragment 1+2(6 weeks)
- Plasma concentration of Plasmin-antiplasmin complex(6 weeks)
- Plasma concentration of Lp(a)(6 weeks)