Effects of Peas on Blood Glucose Control

NCT02552823 | Unknown

• 1 other identifier: H29
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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. 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. 2.To assess the effect of 3 common market classes of peas on appetite-related sensations using visual analog scales.
3. 3.To demonstrate whether the test and reference products were liked or disliked similarly by participants.
4. 4.To assess any gastrointestinal side effects from eating the test products

Conditions

Post-prandial Glucose Response

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Hunger (Visual analogue scales)

  up to 2 hours following a meal

• Fullness (Visual analogue scales)

  up to 2 hours following a meal

• Desire to eat (Visual analogue scales)

  up to 2 hours following a meal

Other Outcomes (2)

• Acceptability of test products based on sensory scales

  immediately after eating test product

• Gastrointestinal side effects

  up to 24 hours following a meal

Study Arms (10)

White bread 1

PLACEBO COMPARATOR

Groups 1 and 2, Visit 1 White bread (equal to 50g available carbohydrate) given to fasting participant

Other: Group1; Other: Group2

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

Other: Group1

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

Other: Group1

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

Other: Group1

Rice

EXPERIMENTAL

Group 1, Visit 2-5 Rice (equal to 50g available carbohydrate) given as breakfast to fasting participants

Other: Group1

White bread 2

PLACEBO COMPARATOR

Groups 1 and 2, Visit 6 White bread (equal to 50g available carbohydrate) given to fasting participant

Other: Group1; Other: Group2

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

Other: Group2

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

Other: Group2

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

Other: Group2

Potato

EXPERIMENTAL

Group2, Visit 2-5 Potato (equal to 50g available carbohydrate) given as breakfast to fasting participants

Other: Group2

Interventions

Group1 OTHER

Also known as: Peas with Rice

Pea variety 1 with rice; Pea variety 2 with rice; Pea variety 3 with rice; Rice; White bread 1; White bread 2

Group2 OTHER

Also known as: Peas with potato

Pea variety 1 with potato; Pea variety 2 with potato; Pea variety 3 with potato; Potato; White bread 1; White bread 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating;
• Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L or use of insulin or oral medication to control blood sugar;
• Medical history of cardiovascular disease
• Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg;
• Fasting plasma total cholesterol \>7.8 mmol/L;
• Fasting plasma HDL \<0.9 mmol/L;
• Fasting plasma LDL \>5.0 mmol/L;
• Fasting plasma triglycerides \>2.3 mmol/L;
• A change in blood glucose concentration less than 1 mmol/L between baseline and 30 minutes after consumption of white bread at visit 1;
• Maximum blood glucose concentration occurs after 60 minutes after consumption of white bread at visit 1;
• Major surgery within the last 3 months;
• Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
• Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
• Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
• 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;

Sponsors & Collaborators

• St. Boniface Hospital: lead
• Agriculture and Agri-Food Canada: collaborator

Study Sites (1)

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (8)

• 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.

  PMID: 2547300 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.

  PMID: 22145774 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.

  PMID: 20492127 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.

  PMID: 24797207 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.

  PMID: 22054112 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.

  PMID: 21957874 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.

  PMID: 12816777 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.

  PMID: 19526214 BACKGROUND

Study Officials

• Heather J Blewett, PhD

  Agriculture and Agri-Food Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: September 17, 2015
• Study Start: October 16, 2015
• Primary Completion: August 14, 2017
• Study Completion: January 1, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

CA (1)