Status:
ACTIVE_NOT_RECRUITING
Effect of Peas in Muffins 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 postprandial glycaemic response and appetite related sensations to peas in muffins will be conducted at the I.H. Asper Clinical Resea...
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 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03306706
Start Date
November 7 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