Clinical trial NCT03506932: Effect of Pea Flour in Bread on Blood Glucose
Official title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Yellow Pea Flour in Bread on Post-prandial Glycaemic Response in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-prandial Glycaemic Response
Keywords: blood sugar
insulin
peas
bread
metabolites
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
name: University of Manitoba
name: Saskatchewan Pulse Growers
First posted: 2018-04-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled, cross-over study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Post-prandial glucose
timeFrame: 120 minutes
measure: Post-prandial insulin
timeFrame: 120 minutes
Secondary outcomes:
measure: Urinary metabolite profile
timeFrame: 120 minutes
measure: Plasma metabolite profile
timeFrame: 120 minutes
Other outcomes:
measure: Hunger
timeFrame: 120 minutes
measure: Fullness
timeFrame: 120 minutes
measure: Desire to eat
timeFrame: 120 minutes
measure: Prospective consumption
timeFrame: 120 minutes
measure: Acceptability of test products
timeFrame: 15 minutes
measure: Gastrointestinal effects
timeFrame: 24 hours
Locations:
city: Winnipeg
country: Canada
facility: I. H. Asper Clinical Research Institute
state: Manitoba
Study officials:
affiliation: Agriculture and Agri-Food Canada
name: Heather Blewett, PhD
role: PRINCIPAL_INVESTIGATOR
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