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临床试验/NCT00874341
NCT00874341已完成1 期

Dose-Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease

Queen's University, Belfast4 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
105
试验地点
4
主要终点
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)

研究概览

简要总结

Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit and vegetables may be associated with reduced insulin resistance and may reduce the risk of the metabolic syndrome. If proven, this relationship may partly explain the inverse association between fruit and vegetable intake and cardiovascular disease risk. There are currently no published dietary interventions that have examined in detail the relationship between fruit and vegetable intake and insulin resistance. There is, however, some preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables may have a beneficial effect on insulin resistance. Evidence to date indicates that an investigation of the direct association between fruit and vegetable intakes and insulin resistance in a carefully controlled intervention study is warranted. This study will investigate the dose-response effect of fruit and vegetable intake on insulin resistance in people who are overweight and at high-risk of CVD using state-of-the-art techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • BMI between 27-35
  • CVD risk >20% over 10 years (using the Joint British Society risk assessment tables)
  • Low consumers of fruit and vegetables (<2 portions per day)

排除标准

  • Existing CVD
  • Food intolerance/sensitivity preventing adherence to a high fruit and vegetable diet
  • Subjects taking antioxidant supplements
  • Surgery within the last 3 months
  • Pregnancy/lactation
  • Subjects following a weight loss diet

结局指标

主要结局

Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)

时间窗: Start and end of 12 week intervention

次要结局

  • Cardiovascular risk factors(Start and end of 12 week intervention)
  • Biochemical markers of nutritional status(Start and end of 12 week intervention)
  • Self-reported intake of fruit and vegetables (number of portions per day)(Start and end of 12 week intervention)

研究者

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

Michelle McKinley

Dr Michelle McKinley

Queen's University, Belfast

研究点 (4)

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