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临床试验/NCT01446068
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

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

发起方
Agroscope Liebefeld-Posieux Research Station ALP
申办方类型
Other
责任方
Sponsor

研究点 (4)

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