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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03128684
Other study ID # REB16-12-883
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date February 9, 2018

Study information

Verified date December 2018
Source University of Guelph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 9, 2018
Est. primary completion date February 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Human Nutraceutical Research Unit Guelph Ontario

Sponsors (4)

Lead Sponsor Collaborator
University of Guelph Agriculture and Agri-Food Canada, Pulse Canada, Saskatchewan Pulse Growers

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Satiety 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
Primary Food Intake Food intake will be measured as kilocalories using an ad libitum cheese pizza test meal Acute: 180 minutes following consumption of treatment
Secondary 24-hour Energy Intake 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
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