Clinical trial NCT03306862: Effect of Peas in Soup on Blood Glucose Control
Official title: A Randomized, Controlled, Cross-over Trial Examining the Effect of Peas in Soup on Post-prandial Glycaemic Response in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-prandial Glycaemia
Keywords: blood sugar
insulin
peas
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
name: University of Manitoba
First posted: 2017-10-11
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 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.

Detailed description: A randomized, controlled, cross-over study designed to examine the post-prandial glycaemic response to peas in soup 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 3 clinic visits in a fasted state. Participants will be given soup containing peas at 2 visits and soup without peas at 1 visit. At each visit participants will provide 7 capillary blood samples via finger poke, 5 questionnaires about their appetite and a questionnaire about the acceptability of the products. Each visit will last approximately 2.5h 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 AST or ALT ≥1.5 times the upper limit of normal (ULN));
12. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 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 (within the last 3 months);
17. Allergies to peas;
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 min
measure: Post-prandial insulin
timeFrame: 120 min
Secondary outcomes:
measure: Hunger
timeFrame: 120 min
measure: Fullness
timeFrame: 120 min
measure: Desire to eat
timeFrame: 120 min
measure: Prospective consumption
timeFrame: 120 min
Other outcomes:
measure: Acceptability of soup color
timeFrame: 15 min
measure: Acceptability of soup aroma
timeFrame: 15 min
measure: Acceptability of soup flavor
timeFrame: 15 min
measure: Acceptability of soup texture
timeFrame: 15 min
measure: Frequency of eating soup
timeFrame: 15 min
measure: Gastrointestinal side effects
timeFrame: 24 h
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
References:
citation: 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.
citation: Public Health Authority of Canada. Diabetes in Canada: Facts and figures from a public health perspective. 2011.
citation: 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.
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