Randomized Controlled Clinical Trial to Gauge the Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Platelet aggregation in response to physiologic agonist, assessed as aggregation/min
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Experimental and control beverage are formulated to be similar color, taste and volume.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 27 kg/m2
排除标准
- •• 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.
研究组 & 干预措施
Erythritol-sweetened beverage
1-gram erythritol/kg body weight/day, divided into three beverage servings and fruit-flavored with Kool-Aid® unsweetened drink mix.
干预措施: Erythritol (Other)
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.
干预措施: Aspartame (Other)
结局指标
主要结局
Platelet aggregation in response to physiologic agonist, assessed as aggregation/min
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)