64 Participants Needed

Peas for Post-Meal Blood Sugar Control

Trial Summary

What is the purpose of this trial?

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

Research Team

HJ

Heather J Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

Eligibility Criteria

This trial is for generally healthy men and women aged 18-40, with a BMI of 18.5-34.5 kg/m2, and normal blood sugar levels (HbA1c <6.0%). Participants must be willing to give informed consent and follow the study's requirements.

Inclusion Criteria

My HbA1c level is below 6.0%.
Willing to provide informed consent
Willing/able to comply with the requirements of the study
See 5 more

Exclusion Criteria

I have diabetes or my fasting blood sugar is high, or I take medication to control my blood sugar.
I have a history of liver disease or my liver tests are higher than normal.
My fasting cholesterol is higher than 7.8 mmol/L.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 6 clinic visits in a fasted state to test the effect of peas on post-prandial glucose response

6 visits over approximately 6-10 weeks
6 visits (in-person)

Follow-up

Participants are monitored for any gastrointestinal side effects and overall health after consuming test products

up to 24 hours following each meal

Treatment Details

Interventions

  • Peas
Trial Overview The trial aims to see how three types of peas affect blood sugar and insulin levels after meals in a controlled setting where participants switch between diets including peas or starchy foods like rice or potatoes.
Participant Groups
10Treatment groups
Experimental Treatment
Placebo Group
Group I: RiceExperimental Treatment1 Intervention
Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants
Group II: PotatoExperimental Treatment1 Intervention
Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants
Group III: Pea variety 3 with riceExperimental Treatment1 Intervention
Group 1, Visit 2-5 Pea variety 3 with rice (25g available carbohydrate of each) given as breakfast to fasting participants
Group IV: Pea variety 3 with potatoExperimental Treatment1 Intervention
Group 2, Visit 2-5 Pea variety 3 with potato (25g available carbohydrate of each) given as breakfast to fasting participants
Group V: Pea variety 2 with riceExperimental Treatment1 Intervention
Group 1, Visit 2-5 Pea variety 2 with rice (25g available carbohydrate of each) given as breakfast to fasting participants
Group VI: Pea variety 2 with potatoExperimental Treatment1 Intervention
Group 2, Visit 2-5 Pea variety 2 with potato (25g available carbohydrate of each) given as breakfast to fasting participants
Group VII: Pea variety 1 with riceExperimental Treatment1 Intervention
Group 1,Visit 2-5 Pea variety 1 with rice (25g available carbohydrate of each) given as breakfast to fasting participants
Group VIII: Pea variety 1 with potatoExperimental Treatment1 Intervention
Group 2, Visit 2-5 Pea variety 1 with potato (25g available carbohydrate of each) given as breakfast to fasting participants
Group IX: White bread 1Placebo Group2 Interventions
Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant
Group X: White bread 2Placebo Group2 Interventions
Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials
55
Recruited
15,000+

Agriculture and Agri-Food Canada

Collaborator

Trials
35
Recruited
2,300+
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