Effects of Lentil Consumption on Post-prandial Blood Glucose and Insulin

October 24, 2016 updated by: Alison Duncan, University of Guelph

The Love of Lentils (LoL) Study: The Effects of Acute Consumption of Common Lentil Varieties on Post-prandial Blood Glucose and Insulin Levels in Healthy Adult

The purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 500µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: white bread, white rice (or white potato), or white rice with lentils (or white potato with lentils). White bread will be consumed on the first study visit and the rest of the meals will take place in random order in the visits following. Each meal will provide a total of 50g available carbohydrate. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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
  • BMI 20-30 kg/m2

Exclusion Criteria:

  • Tobacco use
  • Pregnant or breastfeeding
  • Fasting blood glucose ≥ 7.0 mmol/L
  • 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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: White bread
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: Lentil 1 + white rice
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: Lentil 2 + white rice
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: Lentil 3 + white rice
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: White rice
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: Lentil 1 + potato
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: Lentil 2 + potato
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: Lentil 3 + potato
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).
Experimental: Potato
Other: Various lentil varieties (varying in slow digested starch content)

Randomized, cross-over block design.

Comparison of glycemic and insulinemic responses following meals composed of:

  • white rice or white rice combined with 1 of 3 different lentil varieties or
  • white potato or white potato combined with 1 of 3 different lentil varieties

Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.

Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postprandial blood glucose
Time Frame: Acute- 2 hours following meal
Different meals will be consumed on separate occasions over 3-6 week period.
Acute- 2 hours following meal
Postprandial blood insulin
Time Frame: Acute- 2 hours following meal
Different meals will be consumed on separate occasions over 3-6 week period.
Acute- 2 hours following meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Guelph

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agriculture and Agri-Food Canada
Saskatchewan Pulse Growers
Pulse Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison M Duncan, Ph.D, R.D, University of Guelph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14SE012

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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