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临床试验/NCT00869531
NCT00869531已完成不适用

Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2007年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Body weight and composition

研究概览

简要总结

The aim of this study is to investigate the potential beneficial effect of wholegrain on body weight and composition as well as cardiovascular risk in overweight women.

详细描述

Objective

To study the effect of the 'wholegrain concept', i.e. high intake of wheat wholegrain (WW) vs. refined wheat (RW) grain products on body weight and composition.

Design: In this open-labeled randomized trial, 72 postmenopausal women with metabolic syndrome features were prescribed a mild calorie-restricted diet with a deficit of ~1,250kJ/d. Following 2 weeks run-in period on RW products, they were randomized to 12 weeks intervention with RW or WW products providing 2,000kJ/d.

研究设计

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

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •BMI 27-37
  • •Postmenopausal (>1y) women
  • •40-70 years old

排除标准

  • •Medication (hypertensive treatment not included)
  • •BP > 160/100
  • •Fasting glucose > 7mM
  • •Fasting cholesterol > 6.5mM
  • •Known chronic illnesses

研究组 & 干预措施

WW

Experimental

wholegrain wheat

干预措施: wholegrain (Other)

RW

Active Comparator

refined wheat

干预措施: refined wheat (Other)

结局指标

主要结局

Body weight and composition

时间窗: 0, 6 and 12 wks

次要结局

  • Cardiovascular risk markers(0, 6 and 12 wks)
  • Fecal parameters(0 and 12 wks)

研究者

申办方类型
Other

研究点 (1)

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