Post-prandial Glycaemic Response
Conditions
Keywords
blood sugar, insulin, peas, bread, metabolites
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTUntreated
Bread made with 20% yellow pea flour that was untreated.
DIETARY_SUPPLEMENTHeat treated with 0% moisture
Bread made with 20% yellow pea flour that was heat treated with 0% moisture.
DIETARY_SUPPLEMENTHeat treated with 10% moisture
Bread made with 20% yellow pea flour that was heat treated with 10% moisture.
DIETARY_SUPPLEMENTWheat
Bread made with 100% wheat
Sponsors
Agriculture and Agri-Food Canada
University of Manitoba
Saskatchewan Pulse Growers
St. Boniface Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, controlled, cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN)); 12. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥3 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, and cannabis in any form (within the last 3 months); 17. Allergies to peas or wheat; 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial glucose | 120 minutes | incremental area under the curve (iAUC) for glucose |
| Post-prandial insulin | 120 minutes | iAUC insulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary metabolite profile | 120 minutes | Concentration of metabolites in urine |
| Plasma metabolite profile | 120 minutes | Concentration of metabolites in plasma |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of test products | 15 minutes | Ratings of color, aroma, flavor, texture and frequency of eating |
| Hunger | 120 minutes | Area under the curve (AUC) using visual analog scales |
| Gastrointestinal effects | 24 hours | Incidence of gastrointestinal side effects |
| Fullness | 120 minutes | AUC using visual analog scales |
| Desire to eat | 120 minutes | AUC using visual analog scales |
| Prospective consumption | 120 minutes | AUC using visual analog scales |
Countries
Canada
Outcome results
None listed