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临床试验/NCT02999867
NCT02999867已完成不适用

Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Metabolic and Nutritional Status of Patients With Type 2 Diabetes Mellitus

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年3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
180
试验地点
1
主要终点
response to the dietary intervention by the change from baseline in blood glucose at 30-day

研究概览

简要总结

This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean intervention for health improvement in patients with type 2 diabetes.

详细描述

The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients will be assigned to control or intervention group (A diet including triticale and mung bean; B diet including adzuki bean). Blood and urine samples will be collected at baseline and after 30 days of intervention.

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
Single (Participant)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients between the ages of 30 and 65 years
  • patients has been diagnosed as type 2 diabetes mellitus
  • Patients who like to be followed up for 2 months.

排除标准

  • Women in pregnancy or lactation.
  • Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.

研究组 & 干预措施

M1 triticale and mung bean

Experimental

M1: triticale and mung bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.

干预措施: triticale and mung bean (Dietary Supplement)

M2 adzuki bean

Experimental

M2: adzuki bean as a processed food is assigned to patients at a dose of 50-100 g/d for 30-day dietary intervention.

干预措施: adzuki bean (Dietary Supplement)

结局指标

主要结局

response to the dietary intervention by the change from baseline in blood glucose at 30-day

时间窗: baseline and 30 d

response to the dietary intervention by the change from baseline in lipid profile at 30-day

时间窗: baseline and 30 d

response to the dietary intervention by the change from baseline in insulin resistance at 30-day

时间窗: baseline and 30 d

次要结局

  • response to the dietary intervention by the change from baseline in renal function at 30-day(baseline and 30 d)
  • response to the dietary intervention by the change from baseline in liver function at 30-day(baseline and 30 d)
  • response to the dietary intervention by the change from baseline in inflammation result at 30-day(baseline and 30 d)
  • response to the dietary intervention by the change from baseline in folic acid absorption at 30-day(baseline and 30 d)
  • response to the dietary intervention by the change from baseline in iron absorption at 30-day(baseline and 30 d)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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