- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03128684
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
Completed
Conditions
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.
Sponsor
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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