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临床试验/NCT00728143
NCT00728143已完成不适用

Therapeutic Trials of Low Glycemic Index Foods and Dietary Fiber in the Management of Diabetes, Hyperlipidemia and Renal Disease

Unity Health Toronto0 个研究点目标入组 19 人开始时间: 2008年8月5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
19
主要终点
Glycemic Index

研究概览

简要总结

Our objective was to test whether the highly viscous polysaccharide incorporated into the biscuit formulation would reduce the postprandial blood glucose response equally in healthy subjects and individuals with type 2 diabetes.

详细描述

Despite significant achievements in treatment modalities and preventive measures, diabetes has been increasing exponentially. Reduction in both fasting and prolonged postprandial glycemia is of paramount importance in the disease prevention and the delay of diabetic complications. Blood glucose concentration can be reduced by dietary means, and may be influenced by factors such as type and amount of carbohydrate, nature of starch, quantity of protein and fat, dietary fiber content, method of food processing, particle size and food form. Glycemic index (GI) is a measure of the blood glucose-raising ability of the available carbohydrate in foods. Although evidence is often insufficient and individual differences occur, prospective studies and clinical trials have shown that low-GI diets may reduce the risk of diabetes and improve glycemic control in diabetes.

High postprandial plasma glucose level can increase severity of diabetes and foods which raise the blood glucose level least for a given carbohydrate content are most suitable for individuals with type 2 diabetes. Lower postprandial glycemia is also important for healthy subjects to prevent diabetes.

High fiber diets have been recommended for the general population and for the nutritional management of patients with type 2 diabetes. Soluble dietary fiber retards digestion and absorption of the associated dietary carbohydrate, thus flattening the postprandial rise in plasma glucose and insulin concentrations. Some foods such as beta-glucan fiber containing oats and barley, and soluble fibers isolates such as pectin, guar, psyllium, or glucomannan have a high viscosity which gives them the greatest blood glucose lowering effect. Viscous fibers, as a result of their rheological properties, form gel with the food and human digesta and consequently reduce postprandial increases in plasma glucose concentrations in both normal and diabetic subjects in positive relation to their level of viscosity. Insoluble fibers such as cellulose and wheat bran have little effect.

The highly viscous polysaccharide (HVP) added to the study biscuit formulation is a blend of highly viscous soluble fibers (polysaccharides) that act synergistically to develop a higher level of viscosity than any other known dietary fiber in nature. One of the main components of the HVP is glucomannan, a glucose-mannose polysaccharide obtained from grinding the tuber root of Amorphophallus Konjac C. Koch, a plant that has been used as food and remedy for thousands of years in the Far East. Highly refined glucomannan is 3 times more viscous than guar and approximately 7 times more viscous than psyllium. The viscosity of the HVP is amplified further with a viscosity 3-5 times higher than glucomannan alone used in formulation, that is considered to be the highest viscosity single dietary fiber. Previously we and others have shown that the higher viscosity in vitro directly corresponded to lower blood glucose.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •males or non-pregnant females aged 18-75 years and in good health;
  • •BMI <30 kg/m2.

排除标准

  • •known history of hepatitis, diabetes or a heart condition;
  • •using medications or fiber supplements;
  • •any health condition which might affect the results;
  • •non-compliance with the experimental procedures.
  • •Inclusion Criteria (arm 2):
  • •documented type 2 diabetes for at least 6 month duration without clinically manifest complications;
  • •age 18-75 years;
  • •BMI <30 kg/m
  • •Exclusion Criteria (arm 2):
  • •liver or kidney disease;
  • •gastrointestinal problems;
  • •using fiber supplements;
  • •non-compliance with the experimental procedures;
  • •pregnancy.

研究组 & 干预措施

1

Active Comparator

Healthy subjects

干预措施: Highly viscous polysaccharide enriched biscuits (Dietary Supplement)

2

Experimental

Diabetic subjects

干预措施: Highly viscous polysaccharide enriched biscuits (Dietary Supplement)

结局指标

主要结局

Glycemic Index

时间窗: Two months

次要结局

  • Palatability(Two months)

研究者

申办方类型
Other

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