Effects of Peas on Blood Glucose Control
- Conditions
- Post-prandial Glucose Response
- Interventions
- Other: Group2Other: Group1
- Registration Number
- NCT02552823
- Lead Sponsor
- St. Boniface Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Potato Group2 Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants Rice Group1 Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants White bread 1 Group1 Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant White bread 1 Group2 Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant Pea variety 1 with potato Group2 Group 2, Visit 2-5 Pea variety 1 with potato (25g available carbohydrate of each) given as breakfast to fasting participants Pea variety 2 with rice Group1 Group 1, Visit 2-5 Pea variety 2 with rice (25g available carbohydrate of each) given as breakfast to fasting participants White bread 2 Group1 Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant Pea variety 1 with rice Group1 Group 1,Visit 2-5 Pea variety 1 with rice (25g available carbohydrate of each) given as breakfast to fasting participants Pea variety 3 with rice Group1 Group 1, Visit 2-5 Pea variety 3 with rice (25g available carbohydrate of each) given as breakfast to fasting participants White bread 2 Group2 Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant Pea variety 2 with potato Group2 Group 2, Visit 2-5 Pea variety 2 with potato (25g available carbohydrate of each) given as breakfast to fasting participants Pea variety 3 with potato Group2 Group 2, Visit 2-5 Pea variety 3 with potato (25g available carbohydrate of each) given as breakfast to fasting participants
- Primary Outcome Measures
Name Time Method Postprandial blood insulin 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 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 Outcome Measures
Name Time Method Fullness (Visual analogue scales) up to 2 hours following a meal Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes
Desire to eat (Visual analogue scales) up to 2 hours following a meal Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes
Hunger (Visual analogue scales) up to 2 hours following a meal Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes
Trial Locations
- Locations (1)
I. H. Asper Clinical Research Institute
🇨🇦Winnipeg, Manitoba, Canada