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

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

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

    • 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 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
Intervention / Treatment
EXPERIMENTAL: 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
Consumption of split red lentil muffin; consumption of ad libitum pizza test meal after 180 minutes
PLACEBO_COMPARATOR: Wheat Muffin
Consumption of wheat muffin; consumption of ad libitum pizza test meal after 180 minutes
EXPERIMENTAL: 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
Consumption of split red lentil chili; consumption of ad libitum pizza test meal after 180 minutes
PLACEBO_COMPARATOR: Rice Chili
Consumption of rice chili; consumption of ad libitum pizza test meal after 180 minutes

What is the study measuring?

Primary Outcome Measures

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

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.

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.

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)

May 1, 2017

Primary Completion (ACTUAL)

February 8, 2018

Study Completion (ACTUAL)

February 9, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 15, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID 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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