Effect of Peas in Soup on Blood Glucose Control (PEA4)

A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Soup on Post-prandial Glycaemic Response in Healthy Adults.

This study is part of a group of studies whose overall goal is to accurately define the physiochemical and structural effects of pea varieties and relate these to blood glucose attenuation in healthy human volunteers.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-prandial Glycaemia
• Intervention / Treatment: Dietary supplement: Whole yellow pea soup; Dietary supplement: Split yellow pea soup; Dietary supplement: Potato soup

Detailed Description

A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic response to peas in soup will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. Eligible participants who have provided consent will be asked to attend 3 clinic visits in a fasted state. Participants will be given soup containing peas at 2 visits and soup without peas at 1 visit. At each visit participants will provide 7 capillary blood samples via finger poke, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. Each visit will last approximately 2.5h and be separated by 3-14 days.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H2A6
      • I.H. Asper Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Generally healthy male or female, between the age of 18-40 years;
2. Body mass index (BMI) 18.5-30.0 kg/m2;
3. Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively.
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 blood glucose ≥6.1 mmol/L, HbA1c ≥6.0%, 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. Major surgery within the last 3 months;
10. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
11. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
12. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
13. 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 within the past 6 weeks;
14. Active treatment for any type of cancer within 1 year prior to study start;
15. Shift worker (a system of employment where an individual's normal hours of work are in part, outside the period of normal working day; 6am and 8pm);
16. Smoking, use of tobacco or a nicotine replacement product (within the last 3 months);
17. Allergies to peas;
18. Aversion or unwillingness to eat study foods;
19. Consuming >4 servings of pulses per week;
20. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycaemia or appetite;
21. Participation in another clinical trial, current or in the past 4 weeks;
22. Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.
23. 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole yellow pea; Soup containing 25g available carbohydrates from whole yellow peas. Intervention: Whole yellow pea soup	Dietary supplement: Whole yellow pea soup; Soup containing whole yellow peas
Experimental: Split yellow pea; Soup containing 25g available carbohydrates from split yellow peas. Intervention: Split yellow pea soup	Dietary supplement: Split yellow pea soup; Soup containing split yellow peas
Placebo Comparator: Potato; Soup containing 25g available carbohydrates from potatoes. Intervention: Potato soup	Dietary supplement: Potato soup; Soup containing potatoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial glucose	iAUC for glucose	120 min
Post-prandial insulin	iAUC for insulin	120 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hunger	AUC using visual analog scales	120 min
Fullness	AUC using visual analog scales	120 min
Desire to eat	AUC using visual analog scales	120 min
Prospective consumption	AUC using visual analog scales	120 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of soup color	Ratings on a scale of 1-9	15 min
Acceptability of soup aroma	Ratings on a scale of 1-9	15 min
Acceptability of soup flavor	Ratings on a scale of 1-9	15 min
Acceptability of soup texture	Ratings on a scale of 1-9	15 min
Frequency of eating soup	Ratings on a scale of 1-9	15 min
Gastrointestinal side effects	Incidence of gastrointestinal effects	24 h

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Collaborators: University of Manitoba; Agriculture and Agri-Food Canada
• Investigators: Principal Investigator: Heather Blewett, PhD, Agriculture and Agri-Food Canada

Publications and helpful links

General Publications

• 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.
• Public Health Agency of Canada and the Canadian Institute for Health Information. Obesity in Canada: A joint report from the Public Health Agency of Canada and the Canadian institute for health information. Government of Canada; 2011.
• 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.
• 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.
• Smith CE, Mollard RC, Luhovyy BL, Anderson GH. The effect of yellow pea protein and fibre on short-term food intake, subjective appetite and glycaemic response in healthy young men. Br J Nutr. 2012 Aug;108 Suppl 1:S74-80. doi: 10.1017/S0007114512000700.
• Jenkins DJ, Thorne MJ, Camelon K, Jenkins A, Rao AV, Taylor RH, Thompson LU, Kalmusky J, Reichert R, Francis T. Effect of processing on digestibility and the blood glucose response: a study of lentils. Am J Clin Nutr. 1982 Dec;36(6):1093-101. doi: 10.1093/ajcn/36.6.1093.
• Li H, Song F, Xing J, Tsao R, Liu Z, Liu S. Screening and structural characterization of alpha-glucosidase inhibitors from hawthorn leaf flavonoids extract by ultrafiltration LC-DAD-MS(n) and SORI-CID FTICR MS. J Am Soc Mass Spectrom. 2009 Aug;20(8):1496-503. doi: 10.1016/j.jasms.2009.04.003. Epub 2009 Apr 14.
• Habtemariam S. A-glucosidase inhibitory activity of kaempferol-3-O-rutinoside. Nat Prod Commun. 2011 Feb;6(2):201-3.
• Ames N, Blewett H, Storsley J, Thandapilly SJ, Zahradka P, Taylor C. A double-blind randomised controlled trial testing the effect of a barley product containing varying amounts and types of fibre on the postprandial glucose response of healthy volunteers. Br J Nutr. 2015 May 14;113(9):1373-83. doi: 10.1017/S0007114515000367. Epub 2015 Apr 8.
• Rabiee A, Magruder JT, Grant C, Salas-Carrillo R, Gillette A, DuBois J, Shannon RP, Andersen DK, Elahi D. Accuracy and reliability of the Nova StatStrip(R) glucose meter for real-time blood glucose determinations during glucose clamp studies. J Diabetes Sci Technol. 2010 Sep 1;4(5):1195-201. doi: 10.1177/193229681000400519.
• Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): December 21, 2018
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: insulin; blood sugar; peas
• Other Study ID Numbers: RRC/2017/1704; HS21196 (B2017:123) (Other Identifier: Biomedical Research Ethics Board, University of Manitoba)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication.
• IPD Sharing Time Frame: From the time the data is collected until the manuscript is accepted for publication.
• IPD Sharing Access Criteria: Dan Ramdath, Sora Ludwig and Michel Aliani will have access to data necessary for manuscript preparation.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No