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临床试验/NCT02506582
NCT02506582已完成不适用

The Effects of Jerusalem Artichoke and Fermented Soybean Powder Mixture Supplementation on Glucose Control

Yonsei University0 个研究点目标入组 60 人开始时间: 2013年6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
60
主要终点
Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)

研究概览

简要总结

The purpose of this randomized, double-blind, placebo-controlled study was to determine whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.

详细描述

The objective of this clinical study was to evaluate the effect of jerusalem artichoke and fermented soybean powder mixture supplementation on blood glucose. A randomized, double-blinded, placebo-controlled study was conducted on 60 subjects with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes. The subjects were randomly assigned to either a group ingesting 40 g jerusalem artichoke and fermented soybean powder mixture supplementation daily or a placebo group for 12-week. We assessed fasting and postprandial levels of glucose.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects were with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL.

排除标准

  • glucose lowering medications or insulin injections;
  • abnormal liver or renal function;
  • chronic stomach and intestines disease;
  • chronic alcoholism;
  • pregnancy or intending to become pregnant during time of study.
  • complications;
  • an occupation that could be dangerous if hypoglycemia should occur.

研究组 & 干预措施

Test group

Experimental

jerusalem artichoke and fermented soybeans powder mixture supplementation

干预措施: jerusalem artichoke and fermented soybeans powder mixture (Dietary Supplement)

Placebo group

Placebo Comparator

placebo supplementation

干预措施: placebo (Dietary Supplement)

结局指标

主要结局

Blood glucose level by 2-h oral glucose tolerance tests (OGTTs)

时间窗: 12 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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