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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2018
Source University of Guelph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

Eligible participants will undergo a total of 6 study visits. During each visit, a fasted blood sample will be taken by fingerprick, and approximately 500 µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: two types of lentils, corn, macaroni, white rice, or white potato. All study days will be randomized. Each meal will be served in either 1/4 or 1/2 cup servings depending on the study block. Six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
1/4 cup- Small red lentil

1/4 cup- Small green lentil

1/4 cup- corn

1/4 cup- macaroni

1/4 cup- white potato

1/4 cup- white rice

1/2 cup- small red lentil

1/2 cup- small green lentil

1/2 cup- corn

1/2 cup- macaroni

1/2 cup- white potato

1/2 cup- white rice


Locations

Country Name City State
Canada Human Nutraceutical Research Unit Guelph Ontario

Sponsors (3)

Lead Sponsor Collaborator
University of Guelph Agriculture and Agri-Food Canada, Saskatchewan Pulse Growers

Country where clinical trial is conducted

Canada, 

Outcome

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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