Effect of Peas in Soup on Blood Glucose Control

NCT ID: NCT03306862

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-prandial Glycaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, controlled, cross-over study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Whole yellow pea

Soup containing 25g available carbohydrates from whole yellow peas. Intervention: Whole yellow pea soup

Group Type EXPERIMENTAL

Whole yellow pea soup

Intervention Type DIETARY_SUPPLEMENT

Soup containing whole yellow peas

Split yellow pea

Soup containing 25g available carbohydrates from split yellow peas. Intervention: Split yellow pea soup

Group Type EXPERIMENTAL

Split yellow pea soup

Intervention Type DIETARY_SUPPLEMENT

Soup containing split yellow peas

Potato

Soup containing 25g available carbohydrates from potatoes. Intervention: Potato soup

Group Type PLACEBO_COMPARATOR

Potato soup

Intervention Type DIETARY_SUPPLEMENT

Soup containing potatoes

Interventions

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Whole yellow pea soup

Soup containing whole yellow peas

Intervention Type DIETARY_SUPPLEMENT

Split yellow pea soup

Soup containing split yellow peas

Intervention Type DIETARY_SUPPLEMENT

Potato soup

Soup containing potatoes

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Heather Blewett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather Blewett, PhD

Role: PRINCIPAL_INVESTIGATOR

Agriculture and Agri-Food Canada

Locations

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I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND

Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011.

Reference Type 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.

Reference Type BACKGROUND
PMID: 19526214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2547300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22145774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22916818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6293296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19443236 (View on PubMed)

Habtemariam S. A-glucosidase inhibitory activity of kaempferol-3-O-rutinoside. Nat Prod Commun. 2011 Feb;6(2):201-3.

Reference Type BACKGROUND
PMID: 21425674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25850814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20920440 (View on PubMed)

Other Identifiers

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HS21196 (B2017:123)

Identifier Type: OTHER

Identifier Source: secondary_id

RRC/2017/1704

Identifier Type: -

Identifier Source: org_study_id