NCT01446068已完成早期 1 期
Comparison of Postprandial Inflammation in Lean and Obese Subjects
Agroscope Liebefeld-Posieux Research Station ALP4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Interleukin-6 (serum)
研究概览
简要总结
The purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.
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
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •for lean subjects:
- •* age 25-50
- •* 20\102cm
排除标准
- •for lean and obese subjects:
- •Physiological or psychological diseases
- •Allergies to food or intolerance to high-fat meal
- •Vegetarians
- •Chronic intake of drugs
- •Diabetes mellitus Type I and II
- •Debilitating kidney diseases
- •Debilitating liver diseases
- •Clinically established coronary heart diseases
- •Ingestion of vitamins or dietary supplements during the course of the study
结局指标
主要结局
Interleukin-6 (serum)
时间窗: 4h vs 0h
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h
次要结局
- Glucose (serum)(0h, 1h, 2h, 4h, 6h)
- Triglyceride (serum)(0h, 1h, 2h, 4h, 6h)
- Insulin (serum)(0h, 1h, 2h, 4h, 6h)
- high sensitivity C-Reactive Protein(0h, 1h, 2h, 4h, 6h)
- HDL-cholesterol(0h, 1h, 2h, 4h, 6h)
- Total cholesterol(0h, 1h, 2h, 4h, 6h)
- Total cholesterol / HDL cholesterol(0h, 1h, 2h, 4h, 6h)
- Interleukin-6 (serum)(0h, 1h, 2h, 4h, 6h)
- Glucagon-like-protein-1 (serum)(0h, 1h 2h, 4h, 6h)
- Endotoxin (serum)(0h, 1h, 2h, 4h, 6h)
研究者
研究点 (4)
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