The Effects of Lentil-containing Food Products on Satiety and Food Intake

December 15, 2018 updated by: Alison Duncan, University of Guelph

The Effects of Lentil-containing Food Products on Satiety and Food Intake in Healthy Adults

The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils within food products (muffins and chilies) on satiety and food intake in healthy adults.

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

The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils (small green Eston and red split) within food products (muffins and chilies) on satiety and food intake in healthy adults, for a total of 6 study treatments. A total of 3 to 6 study visits (corresponding to consuming all muffins and/or all chilies) will take place where participants will consume one of the study treatments and subsequently complete satiety questionnaires over 180 minutes to measure satiety as subjective appetite sensations (hunger, fullness, desire to eat, and prospective food consumption). At 180 minutes, participants will receive ad libitum pizza and bottled water to consume until they are comfortably full for a measure of weighed food intake. At the end of each study visit, participants will be given a food scale and instructed to weigh and record all food and drink consumed for the remainder of the day for a measure of 24-hour energy intake.

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.
24

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females
  • Age 18 to 40 years old
  • BMI 20-30 kg/m2

Exclusion Criteria:

  • Blood pressure greater than 140/90 mmHg
  • Major medical condition including a history of AIDS or hepatitis
  • Medical or surgical event requiring hospitalization within 3 months of randomization
  • Any medication use except stable dose (3 months) of oral contraceptives, blood pressure or statin medications
  • Tobacco use
  • Probiotic supplement use
  • Dietary fibre supplement use
  • Natural health products (NHPs) used for glycemic control (all other NHPs are ok, as long as stable for 3 months)
  • Pulse consumption greater than 4 servings per week
  • Food allergy or non-food life threatening allergy
  • Pregnant or breastfeeding
  • Alcohol consumption of greater than 14 drinks per week or greater than 4 drinks per sitting
  • Recent or intended significant weight loss or gain (greater than 4kg in previous 3 months)
  • Elite athletes
  • Shift workers
  • Breakfast skippers
  • Score greater than 11, 9, or 8 on the Three Factor Eating Questionnaire (TFEQ) Cognitive Restraint, Disinhibition, and Hunger scales, respectively
  • Dislike of frozen pizza

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

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: Small Green Lentil Muffin
Other: Small Green Lentil Muffin
Consumption of small green lentil muffin; consumption of ad libitum pizza test meal after 180 minutes
EXPERIMENTAL: Split Red Lentil Muffin
Other: Split Red Lentil Muffin
Consumption of split red lentil muffin; consumption of ad libitum pizza test meal after 180 minutes
PLACEBO_COMPARATOR: Wheat Muffin
Other: Wheat Muffin
Consumption of wheat muffin; consumption of ad libitum pizza test meal after 180 minutes
EXPERIMENTAL: Small Green Lentil Chili
Other: Small Green Lentil Chili
Consumption of small green lentil chili; consumption of ad libitum pizza test meal after 180 minutes
EXPERIMENTAL: Split Red Lentil Chili
Other: Split Red Lentil Chili
Consumption of split red lentil chili; consumption of ad libitum pizza test meal after 180 minutes
PLACEBO_COMPARATOR: Rice Chili
Other: Rice Chili
Consumption of rice chili; consumption of ad libitum pizza test meal after 180 minutes

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
Satiety
Time Frame: Acute: 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after treatment consumption
Satiety will be measured using 100mm visual analog scales (VAS) rating appetite sensations of hunger, fullness, desire to eat, and prospective consumption
Acute: 0, 15, 30, 45, 60, 90, 120, 150, and 180 minutes after treatment consumption
Food Intake
Time Frame: Acute: 180 minutes following consumption of treatment
Food intake will be measured as kilocalories using an ad libitum cheese pizza test meal
Acute: 180 minutes following consumption of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
24-hour Energy Intake
Time Frame: Acute: 24 hours
24-hour energy intake will be measured by providing electronic food scales to participants to weigh and record all food and drink consumed for the rest of the day after leaving the study visit
Acute: 24 hours

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

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 (ACTUAL)

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.
May 1, 2017

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 8, 2018

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 9, 2018

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 20, 2017

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 20, 2017

First Posted (ACTUAL)

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 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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.
December 19, 2018

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.
December 15, 2018

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.
December 1, 2018

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.
  • REB16-12-883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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