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临床试验/NCT01681173
NCT01681173已完成不适用

Investigation of the Effect of Insoluble Dietary Fiber on Carbohydrate and Lipid Metabolism and the Prevention of Diabetes Mellitus Type 2 in Subjects With Impaired Glucose Tolerance

German Institute of Human Nutrition4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年5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
4
主要终点
Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT)

研究概览

简要总结

High intake of insoluble fiber is strongly associated with a reduced incidence of diabetes and cardiovascular events in prospective observation studies. Our primary objective is to compare a life style diabetes prevention program(PRAEDIAS) with and without added insoluble fibers in its effectiveness to prevent incident diabetes type 2 in high risk individuals with impaired glucose tolerance. Subjects with IGT not willing to participate in the intervention will be used as independent controls. Secondary aims are to identify mechanisms of action with regard to body composition, anti-inflammatory and metabolic effects of fibers. We propose a randomized, prospective intervention study. The results will be of general relevance for guidance of fiber intake in the population and will help the food industry to design healthy high fiber foods. Fiber can be added at low cost to numerous foods. Increased fiber intake may therefore provide a simple non-cognitive prevention strategy effective at the population level.

详细描述

The overall objective is to investigate whether insoluble fibers added to standard nutrition can reduce the progression of impairment of glucose metabolism in a high risk population with impaired glucose metabolism. Large prospective cohort studies clearly show that mainly insoluble cereal fiber from whole grains is associated with reduced risk of type 2 diabetes and cardiovascular disease. However, there is a lack of evidence from prospective intervention studies targeted to evaluate the potential of dietary fibers to reduce diabetes and cardiovascular disease as recently stated by the Cochrane Foundation. Dietary fiber intake is generally much lower than currently recommended, which may in part be related to side effects of whole grain nutrients and their gustatory properties. Intestinally uncomfortable effects are at least partly related to fermentation which is much less induced by insoluble non-fermentable fibers than by soluble fermentable fibers. The prospective demonstration of beneficial effects of insoluble fibers in preventing diabetes type 2 will allow detailed nutritional recommendations. This may serve to support the consumption of metabolically beneficial constituents of fiber-rich diets and help to increase fiber intake by high fiber natural nutrients or everyday nutrients enriched in insoluble natural fibers.

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
Triple (Participant, Care Provider, Investigator)

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

  • Impaired glucose tolerance
  • Age>18years old
  • both gender

排除标准

  • Diabetes type 1 and type 2
  • chronic or malignant disease
  • Intake of metabolic influence drugs
  • Food allergies, fiber intolerance

研究组 & 干预措施

Placebo drink

Experimental

Placebo drink, BID

干预措施: Placebo (Dietary Supplement)

Drink enriched in fibers

Experimental

7,5g enriched fiber drinks, BID

干预措施: Fiber (Dietary Supplement)

结局指标

主要结局

Change of 2h-postprandial blood glucose from IGT to diabetes mellitus type 2 or normal glucose tolerance (NGT)

时间窗: 0, 12, 24 months

Change of the glucose metabolism (OGTT)

次要结局

  • Change of insulin secretion(0, 12, 24 months)
  • Assessment of cognitive performance(0, 12, 24 months)
  • Change of insulin sensitivity(0, 12, 24 months)
  • Development of indices for the prediction of fat mass(0, 12, 24 months)
  • Determination of gene expression in adipose tissue(0, 12, 24 month)
  • Expression of inflammatory markers in blood(0, 6, 12, 18, 24 months)
  • Biometric data(0, 6, 12, 18, 24 months)

研究者

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

Prof. Dr. med. Andreas F. H. Pfeiffer

Chief, Department of Clinical Nutrition

German Institute of Human Nutrition

研究点 (4)

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