Healthy Clinical Trial
Official title:
The Effect of Various Serving Sizes of Lentils and Other Starchy Meals on Post Prandial Blood Glucose Response and Insulin
| NCT number | NCT02940158 |
| Other study ID # | 16AU001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2016 |
| Est. completion date | January 8, 2018 |
| Verified date | May 2018 |
| Source | University of Guelph |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice).
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | January 8, 2018 |
| Est. primary completion date | January 8, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria - Healthy men and women - Age 18-40 years - Body mass index (BMI) 20-30 kg/m2 Exclusion Criteria: - Tobacco use - Pregnant or breastfeeding - Fasting blood glucose = 7.0 mmol/L - Two hour blood glucose = 11.1 mmol/L after consuming 75g glucose drink (Oral Glucose Tolerance Test beverage) - Any major medical condition including a history of AIDS or hepatitis - Medical or surgical event requiring hospitalization within 3 months of randomization - Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications - Blood pressure >140/90 mm Hg - Natural health products (NHPs) used for glycemic control - Probiotic supplements - Dietary fibre supplements - Consumption of >4 servings of pulses per week - Food allergy or non-food life threatening allergy - Shift workers - Alcohol consumption >14 drinks/week or >4 drinks/sitting - Recent or intended significant weight loss or gain (>4 kg in previous 3 months) - Elite athletes |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Human Nutraceutical Research Unit | Guelph | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University of Guelph | Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postprandial Blood Glucose | 2 hours Postprandial | ||
| Primary | Postprandial Blood Insulin | 2 hours postprandial |
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