Status:
ACTIVE_NOT_RECRUITING
Effect of Peas in Chili on Blood Glucose and Appetite Control
Lead Sponsor:
St. Boniface Hospital
Collaborating Sponsors:
Agriculture and Agri-Food Canada
University of Manitoba
Conditions:
Post-prandial Glycaemic Response
Satiety
Eligibility:
All Genders
18-40 years
Phase:
NA
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 and appetit...
Detailed Description
A randomized, controlled, cross-over study designed to examine the PPGR and appetite related sensations to peas in chili will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Ma...
Eligibility Criteria
Inclusion
- 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
- 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 AST or ALT ≥1.5 times the upper limit of normal (ULN));
- Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 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 (within the last 3 months);
- Allergies to peas;
- 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.
- Physical Activity Level \>1.8.
- Restraint score \>13 (factor 1) on the Three Factor Eating Questionnaire.
- 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;
Key Trial Info
Start Date :
November 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03306927
Start Date
November 8 2017
End Date
January 1 2025
Last Update
November 29 2024
Active Locations (1)
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1
I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H2A6