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临床试验/NCT01759329
NCT01759329已完成不适用

Health Effects of Coffee Consumption

West German Center of Diabetes and Health2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2011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
发起方
入组人数
118
试验地点
2
主要终点
body weight

研究概览

简要总结

Epidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. Therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.

详细描述

Participants were randomly associated to two groups, a test coffee group and a control coffee group. After coffee abstinence of 1 months, participants in both groups got a coffee machine and coffee pads for three months. Clinical data have been assessed before and after coffee abstinence and after 3 months of coffee consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-69 years
  • BMI ≥27 kg/m2
  • coffee consumption of ≥3 cups per day

排除标准

  • new diagnosed type 2 diabetes during the last 6 months
  • severe diseases with hospital stay during the last 3 months
  • change of body weight of more than 2 kg per week during the last 4 weeks
  • smoking cessation during the last 3 months or planned during the study
  • acute infects
  • chronical diseases with except of type 2 diabetes mellitus
  • regular pharmacological therapy with except of oral antidiabetic medication or contraception
  • lack of contraception in women
  • breastfeeding
  • physical activity of more than 1 hour per day

结局指标

主要结局

body weight

时间窗: 4 months

body weight

次要结局

未报告次要终点

研究者

发起方
West German Center of Diabetes and Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan Martin

principal investigator

West German Center of Diabetes and Health

研究点 (2)

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Health Effects of Coffee Consumption | 临床试验