Postprandial Blood Glucose and Insulin Levels Following Consumption of Lentil-containing Food Products

March 30, 2018 updated by: Alison Duncan, University of Guelph

The Love of Lentils (LoL) Study - Phase 2: The Effect of Acute Consumption of Lentil-containing Food Products on Post-prandial Blood Glucose and Insulin in Healthy Adults

This study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. Blood samples will be obtained by finger prick before and for 2 hours after the meal and analyzed for glucose and insulin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the current study is to determine the effects of lentil-containing food products on postprandial blood glucose and insulin levels in healthy premenopausal women and men aged 18-40 years old.This study will use a randomized crossover design. Participants will complete a series of 9 study visits during which participants will consume 9 study treatment meals consisting of muffins, soup and chilli, with and without lentils. Participants will then have their blood sampled for the following 2 hours by finger prick. Participants will remain seated during the test period. All study visits will occur at the Human Nutraceutical Research Unit and be separated by a washout period of 3-7 days. Throughout the study, it will be asked that participants' lifestyle and physical activity remain unchanged. Participants will be instructed to not start any new dietary approaches, and to not start any new natural health products (unless instructed by a physician).

Study Type

Interventional

Enrollment (Actual)

24

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

  • Canada
    • 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women
  • Age 18-40 years (aiming for equal distribution among 18-29, 30-40 years of age)
  • BMI 20-30 kg/m2

Exclusion Criteria:

  • Diabetes (fasting blood glucose ≥7.0 mmol/L and/or 2hr blood glucose >11.1 mmol/L post-75g OGTT) 1
  • Impaired Glucose Tolerance (IGT) (Fasting blood glucose 6.1-6.9 mmol/L and/or 2hr blood glucose 7.8-11.0 mmol/L post-75g OGTT) 1
  • Blood pressure >140/90 mm Hg
  • 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
  • Natural health products (NHPs) used for glycemic control (all other NHPs okay as long as table for 3 months)
  • Tobacco use
  • Probiotic supplement use
  • Dietary fibre supplement use
  • Pulse consumption >4 servings per week
  • Food allergy or non-food life threatening allergy
  • 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
  • Shift workers

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Small Green Lentil Muffin
Muffin: 25g available carbohydrate from small green lentil
Other: Muffin: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Experimental: Split Red Lentil Muffin
Muffin: 25g available carbohydrate from split red lentil
Other: Muffin: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Placebo Comparator: Wheat Muffin
Muffin: 25g available carbohydrate from wheat
Other: Wheat muffin
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Experimental: Small Green Lentil Soup
Soup: 25g available carbohydrate from small green lentil
Other: Soup: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Experimental: Split Red Lentil Soup
Soup: 25g available carbohydrate from split red lentil
Other: Soup: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Placebo Comparator: Potato Soup
Soup: 25g available carbohydrate from potato
Other: Potato soup
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Experimental: Small Green Lentil Chili
Chili: 25g available carbohydrate from small green lentil
Other: Chili: 25g available carbohydrate from small green lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Experimental: Split Red Lentil Chili
Chili: 25g available carbohydrate from split red lentil
Other: Chili: 25g available carbohydrate from split red lentil
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
Placebo Comparator: Rice Chili
Chili: 25g available carbohydrate from rice
Other: Rice chili
Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postprandial blood glucose
Time Frame: 2 hours postprandial
2 hours postprandial
Postprandial plasma 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

University of Guelph

Collaborators

Agriculture and Agri-Food Canada

Investigators

  • Principal Investigator: Alison M Duncan, PhD, RD, University of Guelph

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 (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

September 25, 2016

First Submitted That Met QC Criteria

October 1, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16AU008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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