- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02940158
Various Serving Sizes of Lentils on Blood Glucose and Insulin
May 2, 2018 updated by: Alison Duncan, University of Guelph
The Effect of Various Serving Sizes of Lentils and Other Starchy Meals on Post Prandial Blood Glucose Response and Insulin
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: 1/2 cup- small red lentil
- Other: 1/2 cup- small green lentil
- Other: 1/2 cup- corn
- Other: 1/2 cup- macaroni
- Other: 1/2 cup- white potato
- Other: 1/2 cup- white rice
- Other: 1/4 cup- Small red lentil
- Other: 1/4 cup- Small green lentil
- Other: 1/4 cup- corn
- Other: 1/4 cup- macaroni
- Other: 1/4 cup- white potato
- Other: 1/4 cup- white rice
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- Human Nutraceutical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1/2 cup
1/2 cup serving size arm
|
|
Other: 1/4 cup
1/4 cup serving size arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postprandial Blood Glucose
Time Frame: 2 hours Postprandial
|
2 hours Postprandial
|
Postprandial Blood Insulin
Time Frame: 2 hours postprandial
|
2 hours postprandial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
January 8, 2018
Study Completion (Actual)
January 8, 2018
Study Registration Dates
First Submitted
September 25, 2016
First Submitted That Met QC Criteria
October 18, 2016
First Posted (Estimate)
October 20, 2016
Study Record Updates
Last Update Posted (Actual)
May 8, 2018
Last Update Submitted That Met QC Criteria
May 2, 2018
Last Verified
May 1, 2018
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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