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Effects of Peas on Blood Glucose Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02552823
Recruitment Status : Active, not recruiting
First Posted : September 17, 2015
Last Update Posted : October 19, 2021
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Heather Blewett, 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

Condition or disease Intervention/treatment Phase
Post-prandial Glucose Response Other: Group1 Other: Group2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas on Post-prandial Glucose Response in Healthy Adults
Actual Study Start Date : October 16, 2015
Actual Primary Completion Date : August 14, 2017
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Placebo Comparator: White bread 1
Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant
Other: Group1
Other Name: Peas with Rice

Other: Group2
Other Name: Peas with potato

Experimental: Pea variety 1 with rice
Group 1,Visit 2-5 Pea variety 1 with rice (25g available carbohydrate of each) given as breakfast to fasting participants
Other: Group1
Other Name: Peas with Rice

Experimental: Pea variety 2 with rice
Group 1, Visit 2-5 Pea variety 2 with rice (25g available carbohydrate of each) given as breakfast to fasting participants
Other: Group1
Other Name: Peas with Rice

Experimental: Pea variety 3 with rice
Group 1, Visit 2-5 Pea variety 3 with rice (25g available carbohydrate of each) given as breakfast to fasting participants
Other: Group1
Other Name: Peas with Rice

Experimental: Rice
Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants
Other: Group1
Other Name: Peas with Rice

Placebo Comparator: White bread 2
Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant
Other: Group1
Other Name: Peas with Rice

Other: Group2
Other Name: Peas with potato

Experimental: Pea variety 1 with potato
Group 2, Visit 2-5 Pea variety 1 with potato (25g available carbohydrate of each) given as breakfast to fasting participants
Other: Group2
Other Name: Peas with potato

Experimental: Pea variety 2 with potato
Group 2, Visit 2-5 Pea variety 2 with potato (25g available carbohydrate of each) given as breakfast to fasting participants
Other: Group2
Other Name: Peas with potato

Experimental: Pea variety 3 with potato
Group 2, Visit 2-5 Pea variety 3 with potato (25g available carbohydrate of each) given as breakfast to fasting participants
Other: Group2
Other Name: Peas with potato

Experimental: Potato
Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants
Other: Group2
Other Name: Peas with potato




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Hunger (Visual analogue scales) [ Time Frame: up to 2 hours following a meal ]
    Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes

  2. Fullness (Visual analogue scales) [ Time Frame: up to 2 hours following a meal ]
    Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes

  3. Desire to eat (Visual analogue scales) [ Time Frame: up to 2 hours following a meal ]
    Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes


Other Outcome Measures:
  1. Acceptability of test products based on sensory scales [ Time Frame: immediately after eating test product ]
    scales will assess overall, colour, aroma, flavour and texture likeability

  2. Gastrointestinal side effects [ Time Frame: up to 24 hours following a meal ]
    After consumption of the test product, any abnormal gastrointestinal side effects will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  1. Generally healthy male or female, between the age of 18-40 years;
  2. Body mass index (BMI) 18.5-34.5 kg/m2;
  3. HbA1c <6.0%;
  4. Willing to provide informed consent;
  5. Willing/able to comply with the requirements of the study.

Exclusion criteria

  1. Pregnant or lactating;
  2. Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L or use of insulin or oral medication to control blood sugar;
  3. Medical history of cardiovascular disease
  4. Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
  5. Fasting plasma total cholesterol >7.8 mmol/L;
  6. Fasting plasma HDL <0.9 mmol/L;
  7. Fasting plasma LDL >5.0 mmol/L;
  8. Fasting plasma triglycerides >2.3 mmol/L;
  9. A change in blood glucose concentration less than 1 mmol/L between baseline and 30 minutes after consumption of white bread at visit 1;
  10. Maximum blood glucose concentration occurs after 60 minutes after consumption of white bread at visit 1;
  11. Major surgery within the last 3 months;
  12. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
  13. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
  14. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
  15. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use with the past 6 weeks;
  16. Active treatment for any type of cancer within 1 year prior to study start;
  17. Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol;
  18. Shift worker;
  19. Tobacco use current or within the last 3 months;
  20. Allergies to peas;
  21. Aversion or unwillingness to eat study foods;
  22. Consuming >4 servings of pulses per week;
  23. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycemia;
  24. Participation in another clinical trial, current or in the past 4 weeks;
  25. Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552823


Locations
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Canada, Manitoba
I. H. Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
St. Boniface Hospital
Agriculture and Agri-Food Canada
Investigators
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Principal Investigator: Heather J Blewett, PhD Agriculture and Agri-Food Canada
Publications:

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Responsible Party: Dr. Heather Blewett, Principal Investigator, St. Boniface Hospital
ClinicalTrials.gov Identifier: NCT02552823    
Other Study ID Numbers: H29
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021