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Clinical Trials/NCT02552823
NCT02552823
Active, not recruiting
Not Applicable

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

St. Boniface Hospital1 site in 1 country64 target enrollmentOctober 16, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-prandial Glucose Response
Sponsor
St. Boniface Hospital
Enrollment
64
Locations
1
Primary Endpoint
Postprandial blood insulin
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2015
End Date
January 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Heather Blewett

Principal Investigator

St. Boniface Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Postprandial blood insulin

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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