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| Name | Class |
|---|---|
| Agriculture and Agri-Food Canada | OTHER_GOV |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White bread 1 | Placebo Comparator | Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant |
|
| Pea variety 1 with rice | Experimental | Group 1,Visit 2-5 Pea variety 1 with rice (25g available carbohydrate of each) given as breakfast to fasting participants |
|
| Pea variety 2 with rice | Experimental | Group 1, Visit 2-5 Pea variety 2 with rice (25g available carbohydrate of each) given as breakfast to fasting participants |
|
| Pea variety 3 with rice | Experimental | Group 1, Visit 2-5 Pea variety 3 with rice (25g available carbohydrate of each) given as breakfast to fasting participants |
|
| Rice | Experimental | Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants |
|
| White bread 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group1 | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial blood glucose | 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 | up to 2 hours following a meal |
| Postprandial blood insulin | 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 | up to 2 hours following a meal |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger (Visual analogue scales) | Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes | up to 2 hours following a meal |
| Fullness (Visual analogue scales) |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of test products based on sensory scales | scales will assess overall, colour, aroma, flavour and texture likeability | immediately after eating test product |
| Gastrointestinal side effects |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Heather J Blewett, PhD | Agriculture and Agri-Food Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I. H. Asper Clinical Research Institute | Winnipeg | Manitoba | R2H 2A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2547300 | Background | Hamberg O, Rumessen JJ, Gudmand-Hoyer E. Blood glucose response to pea fiber: comparisons with sugar beet fiber and wheat bran. Am J Clin Nutr. 1989 Aug;50(2):324-8. doi: 10.1093/ajcn/50.2.324. | |
| 22145774 | Background | Marinangeli CP, Jones PJ. Chronic intake of fractionated yellow pea flour reduces postprandial energy expenditure and carbohydrate oxidation. J Med Food. 2011 Dec;14(12):1654-62. doi: 10.1089/jmf.2010.0255. |
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| Placebo Comparator |
Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant |
|
| Pea variety 1 with potato | Experimental | 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 potato | Experimental | 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 | Experimental | Group 2, Visit 2-5 Pea variety 3 with potato (25g available carbohydrate of each) given as breakfast to fasting participants |
|
| Potato | Experimental | Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants |
|
| Group2 | Other |
|
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Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes
| up to 2 hours following a meal |
| Desire to eat (Visual analogue scales) | Visual analogue scales are administered pre-meal, immediately post-meal and 30, 60, 90 and 120 minutes | up to 2 hours following a meal |
After consumption of the test product, any abnormal gastrointestinal side effects will be recorded
| up to 24 hours following a meal |
| 20492127 | Background | Marinangeli CP, Kassis AN, Jones PJ. Glycemic responses and sensory characteristics of whole yellow pea flour added to novel functional foods. J Food Sci. 2009 Nov-Dec;74(9):S385-9. doi: 10.1111/j.1750-3841.2009.01347.x. |
| 24797207 | Background | Mollard RC, Wong CL, Luhovyy BL, Cho F, Anderson GH. Second-meal effects of pulses on blood glucose and subjective appetite following a standardized meal 2 h later. Appl Physiol Nutr Metab. 2014 Jul;39(7):849-51. doi: 10.1139/apnm-2013-0523. Epub 2014 May 5. |
| 22054112 | Background | Mollard RC, Zykus A, Luhovyy BL, Nunez MF, Wong CL, Anderson GH. The acute effects of a pulse-containing meal on glycaemic responses and measures of satiety and satiation within and at a later meal. Br J Nutr. 2012 Aug;108(3):509-17. doi: 10.1017/S0007114511005836. Epub 2011 Nov 7. |
| 21957874 | Background | Mollard RC, Wong CL, Luhovyy BL, Anderson GH. First and second meal effects of pulses on blood glucose, appetite, and food intake at a later meal. Appl Physiol Nutr Metab. 2011 Oct;36(5):634-42. doi: 10.1139/h11-071. Epub 2011 Sep 29. |
| 12816777 | Background | Schafer G, Schenk U, Ritzel U, Ramadori G, Leonhardt U. Comparison of the effects of dried peas with those of potatoes in mixed meals on postprandial glucose and insulin concentrations in patients with type 2 diabetes. Am J Clin Nutr. 2003 Jul;78(1):99-103. doi: 10.1093/ajcn/78.1.99. |
| 19526214 | Background | Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13. |