Ignite Creation Date:
2024-05-06 @ 7:33 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02552823
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2015-07-27
Brief Title:
Effects of Peas on Blood Glucose Control
Sponsor:
St Boniface Hospital
Organization:
St Boniface Hospital
Study Overview
Official Title:
A Randomized Controlled Cross-over Trial Examining the Effect of Peas on Post-prandial Glucose Response in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 wholesplit 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 Canadas 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
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 IH 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 25h 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None