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临床试验/NCT02549144
NCT02549144已完成不适用

Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects

Azienda Ospedaliero, Universitaria Pisana2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Dichlorofluorescein fluorescence slope

研究概览

简要总结

In this study the investigators aimed at measuring the effect of a two-week high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.

详细描述

HDL particles can change their composition and function in response to a variety of pathological conditions and environmental stimuli. It has been previously shown that a western diet is able to drastically modify biochemical composition, anti-inflammatory and anti-oxidant properties of HDL in animals. In humans little is known on the role of diet on HDL function and composition.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects ≥ 18 and ≤40 years of age
  • Lean or overweight (BMI: 18 to 29,9 kg/m2)
  • Normal liver and kidney function
  • Normal thyroid function
  • Stable weight in the last 3 months
  • Read and understood the informed consent form and signed it voluntarily

排除标准

  • Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases
  • Chronic use of drugs or vitamin supplements
  • Pregnancy or lactation

结局指标

主要结局

Dichlorofluorescein fluorescence slope

时间窗: 14 days

次要结局

  • hydroxyeicosatetraenoic acid(14 days)
  • hydroxyoctadecadienoic acid(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Natali

Professor Andrea Natali

Azienda Ospedaliero, Universitaria Pisana

研究点 (2)

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