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临床试验/NCT01784952
NCT01784952已完成不适用

Consumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant

Yonsei University2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2012年1月最近更新:
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
200
试验地点
2
主要终点
Triglyceride

研究概览

简要总结

We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.

详细描述

We genotyped the APOA5 -1131T>C in individuals with impaired fasting glucose (IFG) or newly diagnosed type 2 diabetes, who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose <126 mg/dL) and newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL) were referred to the Department of Family Medicine or Internal Medicine. They were rechecked for their health and lipid profiles, and then those who satisfied the study criteria were recommended to participate in the dietary intervention program

排除标准

  • Current and/or past history of cardiovascular disease including angina
  • Liver or kidney dysfunction
  • Thyroid or pituitary disease
  • Unstable weight loss/gain (≥2 kg) over the previous 6months
  • Pregnancy or lactation. Subjects who were taking medication were also excluded

研究组 & 干预措施

Whole grains and lequmes

Experimental

干预措施: Dietary intervention (Dietary Supplement)

refined rice

Placebo Comparator

干预措施: Dietary intervention (Dietary Supplement)

结局指标

主要结局

Triglyceride

时间窗: change from baseline in TG at 12 weeks

次要结局

  • Apolipoprotein A5(Change from baseline in ApoA5 at 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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