Effect of Pea Flour in Bread on Blood Glucose

Study Overview
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Brief Summary
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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.

Detailed Description
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A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic response, metabolism of bioactives and appetite related sensations to 20% incorporation of yellow pea flour (untreated, heat treated with 0% moisture and heat treated with 10% moisture) into bread 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 4 clinic visits in a fasted state. Participants will be given bread containing 20% yellow pea flour at 3 visits and bread with 100% wheat flour at 1 visit. At each visit participants will provide 7 venous blood samples via indwelling catheter, 7 capillary blood samples via finger poke, 2 urine samples, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. Each visit will last approximately 3h and be separated by 3-14 days.

Official Title
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A Randomized, Controlled, Cross-over Trial Examining the Effect of Yellow Pea Flour in Bread on Post-prandial Glycaemic Response in Healthy Adults

Conditions
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Post-prandial Glycaemic Response

Intervention / Treatment
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* Dietary Supplement: Untreated
* Dietary Supplement: Heat treated with 0% moisture
* Dietary Supplement: Heat treated with 10% moisture
* Dietary Supplement: Wheat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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); Smoking, use of tobacco or a nicotine replacement product, and cannabis in any form (within the last 3 months); Allergies to peas or wheat; Aversion or unwillingness to eat study foods; Consuming >4 servings of pulses per week; Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycaemia or appetite; Participation in another clinical trial, current or in the past 4 weeks; Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program. 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, controlled, cross-over study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Untreated<br>Bread containing 20% yellow pea flour. | Dietary Supplement: Untreated<br>* Bread made with 20% yellow pea flour that was untreated.<br>|
| Experimental: Heat treated with 0% moisture<br>Bread containing 20% yellow pea flour. | Dietary Supplement: Heat treated with 0% moisture<br>* Bread made with 20% yellow pea flour that was heat treated with 0% moisture.<br>|
| Experimental: Heat treated with 10% moisture<br>Bread containing 20% yellow pea flour. | Dietary Supplement: Heat treated with 10% moisture<br>* Bread made with 20% yellow pea flour that was heat treated with 10% moisture.<br>|
| Active Comparator: Wheat<br>Bread made with 100% wheat flour | Dietary Supplement: Wheat<br>* Bread made with 100% wheat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial glucose | incremental area under the curve (iAUC) for glucose | 120 minutes | 
| Post-prandial insulin | iAUC insulin | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary metabolite profile | Concentration of metabolites in urine | 120 minutes | 
| Plasma metabolite profile | Concentration of metabolites in plasma | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood sugar, insulin, peas, bread, metabolites