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临床试验/NCT02552823
NCT02552823进行中(未招募)不适用

A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas on Post-prandial Glucose Response in Healthy Adults

St. Boniface Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
64
试验地点
2
主要终点
Postprandial blood insulin

研究概览

简要总结

Diabetes is one of the most common chronic diseases affecting Canadians (PHAC, 2011). Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). In this context, the presence of fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response (PPGR). Peas are high in fibre and protein and show great potential as a functional food. A health claim for PPGR would increase market demand for peas, and help those who want to limit the rise in blood sugar after a meal choose products to meet their goals, but there are several gaps in the literature that need to be filled before a submission to Health Canada can be successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin response; 3) test varieties of peas that that currently available on the market; 4) test whole/split peas (not fractions or isolates); 5) compare peas to appropriate starchy reference food (rice or potato). The proposed study design will address all of these gaps in the current literature and take into consideration Health Canada's guidance document for health claims related to the reduction in PPGR, which sets out the criteria by which the validity of such claims will be assessed.

Specific objectives

  1. To determine the effect of 3 common market classes of peas on PPGR and insulin response in a cross-over, randomized, controlled clinical trial.
  2. To assess the effect of 3 common market classes of peas on appetite-related sensations using visual analog scales.
  3. To demonstrate whether the test and reference products were liked or disliked similarly by participants.
  4. To assess any gastrointestinal side effects from eating the test products

详细描述

A randomized, controlled, cross-over study designed to examine the PPGR to peas will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. The study will be divided into 2 groups of 24 healthy volunteers each. In Group 1, eligible participants who have provided consent will be asked to attend 6 clinic visits in a fasted state. Participants will be given white bread at their first and last visits, peas with rice at 3 visits and rice at 1 visit. At each visit participants will provide 7 blood samples via finger poke, 6 questionnaires about their appetite and a questionnaire about the acceptability of the test food. Each visit will last approximately 2.5h and be separated by 3-10 days. Group 2 will undergo the exact same study procedures as group 1, but rice will be replaced with potato.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Postprandial blood insulin

时间窗: up to 2 hours following a meal

samples collected to test insulin at fasting and at 15,30,45,60,90 and 120 minutes after the first bite of the test product

Postprandial blood glucose

时间窗: up to 2 hours following a meal

samples collected to test glucose at fasting and at 15,30,45,60,90 and 120 minutes after the first bite of the test product

次要结局

  • Fullness (Visual analogue scales)(up to 2 hours following a meal)
  • Desire to eat (Visual analogue scales)(up to 2 hours following a meal)
  • Hunger (Visual analogue scales)(up to 2 hours following a meal)

研究者

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

Dr. Heather Blewett

Principal Investigator

St. Boniface Hospital

研究点 (2)

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