Effect of Pea Flour in Bread on Blood Glucose

NCT03506932 | Completed

• 2 other identifiers: HS21603 (B2018:026)RRC/2018/1748
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study's overall goal is to investigate methods to improve the acceptability of pulse containing foods that provide a health benefit to consumers. The health benefits we are testing are post-prandial blood glucose attenuation and appetite related sensations in healthy human volunteers.

Conditions

Post-prandial Glycaemic Response

Keywords

blood sugar; insulin; peas; bread; metabolites

Outcome Measures

Primary Outcomes (2)

• Post-prandial glucose

  incremental area under the curve (iAUC) for glucose

  120 minutes

• Post-prandial insulin

  iAUC insulin

  120 minutes

Secondary Outcomes (2)

• Urinary metabolite profile

  120 minutes

• Plasma metabolite profile

  120 minutes

Other Outcomes (6)

• Hunger

  120 minutes

• Fullness

  120 minutes

• Desire to eat

  120 minutes

Study Arms (4)

Untreated

EXPERIMENTAL

Bread containing 20% yellow pea flour.

Dietary Supplement: Untreated

Heat treated with 0% moisture

EXPERIMENTAL

Bread containing 20% yellow pea flour.

Dietary Supplement: Heat treated with 0% moisture

Heat treated with 10% moisture

EXPERIMENTAL

Bread containing 20% yellow pea flour.

Dietary Supplement: Heat treated with 10% moisture

Wheat

ACTIVE COMPARATOR

Bread made with 100% wheat flour

Dietary Supplement: Wheat

Interventions

Untreated DIETARY_SUPPLEMENT

Bread made with 20% yellow pea flour that was untreated.

Untreated

Heat treated with 0% moisture DIETARY_SUPPLEMENT

Bread made with 20% yellow pea flour that was heat treated with 0% moisture.

Heat treated with 0% moisture

Heat treated with 10% moisture DIETARY_SUPPLEMENT

Bread made with 20% yellow pea flour that was heat treated with 10% moisture.

Heat treated with 10% moisture

Wheat DIETARY_SUPPLEMENT

Bread made with 100% wheat

Wheat

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 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN));
• Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥3 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
• Saskatchewan Pulse Growers: collaborator

Study Sites (1)

I. H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (17)

• 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

• 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

• Robinson DS, Wu Z, Domoney C, Casey R. Lipoxygenases and the quality of foods. Food Chem 54:33-43,1995.

  BACKGROUND

• Rackis JJ, Sessa DJ, Honig DH. Flavor problems of vegetable food proteins. J Am Oil Chem Soc 56(3):262-71,1979.

  BACKGROUND

• Shariati-Ievari S, Ryland D, Edel A, Nicholson T, Suh M, Aliani M. Sensory and Physicochemical Studies of Thermally Micronized Chickpea (Cicer arietinum) and Green Lentil (Lens culinaris) Flours as Binders in Low-Fat Beef Burgers. J Food Sci. 2016 May;81(5):S1230-42. doi: 10.1111/1750-3841.13273. Epub 2016 Mar 15.

  PMID: 26990186 BACKGROUND

• Mitzak, M. 2007. Method for heat treatment of powdery materials (Google Patents).

  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

• Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.

  PMID: 20122136 BACKGROUND

• European Food Safety Authority. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal. 10(3):2604, 2012.

  BACKGROUND

• Health Canada. Draft guidance document: Satiety health claims on food [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/consult/satiety-satiete/document-consultation-eng.php

  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

• Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.

  PMID: 19079901 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

• 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

MeSH Terms

Conditions

Insulin Resistance

Interventions

Flour

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: April 13, 2018
• First Posted: April 24, 2018
• Study Start: April 17, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• 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 manuscript is accepted for publication.
• Access Criteria: Michel Aliani and Sora Ludwig will have access to data necessary for manuscript preparation.

Locations

CA (1)