Zhongshan Ketogenic Diet Study 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Platelet aggregation and ATP release
研究概览
简要总结
This dietary intervention study was designed to investigate the impact of a ketogenic diet on platelet function and and thrombus formation. Based on our preclinical observations, the study also aimed to discover whether aspirin could effectively counteract the ketogenic diet-induced enhancement of platelet function and attenuate the associated prothrombotic state.
详细描述
A randomized controlled trial was conducted to evaluate the impact of a ketogenic diet (KD) on platelet function and thrombus formation compared to a normal diet. Participants who met the specified inclusion and exclusion criteria were randomly assigned to either the KD group or the control group. The KD group followed a calorie-restricted, very-low-carbohydrate, high-fat diet for 7 days (5% carbohydrates, 30% protein, 65% fat, with a daily energy deficit of 600 kcal). To ensure compliance, one meal per day was provided as a commercial replacement. The normal diet group was instructed to maintain their original eating habits and rhythms. Whole blood was collected from the median cubital vein at baseline (pre-intervention) and after 7 days of the dietary intervention. Plasma ketone body levels were measured at both time points. To determine the effects of aspirin, the post-intervention whole blood was incubated ex vivo with either aspirin or a vehicle control. Platelet function was subsequently analyzed using platelet aggregation and ATP release assays, while thrombus formation was evaluated using a microfluidic whole-blood perfusion assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants reside in Shanghai.
- •Participants have completed Zhongshan Ketogenic Diet Study 1 in 2025.
排除标准
- •Pecent anti-platelet drug usage.
- •Participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases.
- •Participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication.
- •Being or to be pregnant or lactating.
- •Participants with bulimia nervosa, post-traumatic stress disorder , chronic anxiety and depression or other critical neuronal disorder or history of relevant medication.
结局指标
主要结局
Platelet aggregation and ATP release
时间窗: Day 8
Platelet aggregation and ATP release were measured simultaneously using a lumi-aggregometer. Platelet aggregation was stimulated with collagen, thrombin, and ADP, while ATP release was induced by collagen and thrombin.
次要结局
- Thrombus formation(Day 8)