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临床试验/NCT02671214
NCT02671214已完成不适用

The Effect of Selected Fibres and Flours in Flat Bread on Post-prandial Blood Glucose Responses

Unilever R&D2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Positive incremental area under the curve (iAUC)

研究概览

简要总结

Identify one or more flat bread mixes that produce a reduction in positive incremental area under the curve (iAUC) of post-prandial glucose relative to the control product.

详细描述

This study was a double-blind, randomised, balanced incomplete block design exploratory study of efficacy, with 11 active treatments compared to a control product in 42 healthy subjects to see if a mix of active ingredients (viscous fibres and flours) lowered the post-prandial glucose (PPG) response in capillary blood (finger prick) over a two and three hours period, relative to the control product. Every subject received the control and 4 out of the 11 treatments on five separate test days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) ≥ 20 and ≤ 25.0 kg/m
  • Apparently healthy: no medical conditions which might affect study measurements (as judged by the study physician).
  • A fasting blood glucose value between 3.5 - 5.6 mmol/litre at screening (measured by finger prick).

排除标准

  • Use of medication which interferes with study measurements (as judged by the study physician).
  • Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
  • Reported weight loss/gain (>10%) in the last six month before the study

结局指标

主要结局

Positive incremental area under the curve (iAUC)

时间窗: 120 minutes

次要结局

  • Positive incremental area under the curve (iAUC)(180 minutes)

研究者

发起方
Unilever R&D
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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