Effect of Peas in Soup on Blood Glucose Control

NCT03306862 | Active Not Recruiting

• 2 other identifiers: RRC/2017/1704HS21196 (B2017:123)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-prandial Glycaemia

Keywords

blood sugar; insulin; peas

Outcome Measures

Primary Outcomes (2)

• Post-prandial glucose

  iAUC for glucose

  120 min

• Post-prandial insulin

  iAUC for insulin

  120 min

Secondary Outcomes (4)

• Hunger

  120 min

• Fullness

  120 min

• Desire to eat

  120 min

• Prospective consumption

  120 min

Other Outcomes (6)

• Acceptability of soup color

  15 min

• Acceptability of soup aroma

  15 min

• Acceptability of soup flavor

  15 min

Study Arms (3)

Whole yellow pea

EXPERIMENTAL

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

Dietary Supplement: Whole yellow pea soup

Split yellow pea

EXPERIMENTAL

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

Dietary Supplement: Split yellow pea soup

Potato

PLACEBO COMPARATOR

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

Dietary Supplement: Potato soup

Interventions

Whole yellow pea soup DIETARY_SUPPLEMENT

Soup containing whole yellow peas

Whole yellow pea

Split yellow pea soup DIETARY_SUPPLEMENT

Soup containing split yellow peas

Split yellow pea

Potato soup DIETARY_SUPPLEMENT

Soup containing potatoes

Potato

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) 18.5-30.0 kg/m2;
• Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively.
• 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 blood glucose ≥6.1 mmol/L, HbA1c ≥6.0%, 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;
• 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 within the past 6 weeks;
• Active treatment for any type of cancer within 1 year prior to study start;
• 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);

Sponsors & Collaborators

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

Study Sites (1)

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H2A6, Canada

Location

Related Publications (11)

• 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.

  BACKGROUND

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

  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

• 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

• 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.

  PMID: 22916818 BACKGROUND

• 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.

  PMID: 6293296 BACKGROUND

• 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.

  PMID: 19443236 BACKGROUND

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

  PMID: 21425674 BACKGROUND

• 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.

  PMID: 25850814 BACKGROUND

• 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.

  PMID: 20920440 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Heather Blewett, PhD

  Agriculture and Agri-Food Canada

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized, controlled, cross-over study

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 11, 2017
• Study Start: November 8, 2017
• Primary Completion: December 21, 2018
• Study Completion: January 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the time the data is collected until the manuscript is accepted for publication.
• Access Criteria: Dan Ramdath, Sora Ludwig and Michel Aliani will have access to data necessary for manuscript preparation.

Locations

CA (1)