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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05152693
Other study ID # FoodVariety101
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date January 27, 2023

Study information

Verified date November 2021
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to gain a better understanding of the combined effects of meal variety and portion size on food intake at a meal. The study will also explore relationships with eating microstructure such as eating rate and bite size. Additionally, other individual characteristics will be examined for their influence on the effects of variety and portion size on meal intake.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 27, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Be willing and able to travel to Penn State University Park campus weekly for meals - Be fully vaccinated against COVID-19 - Be a woman 20 - 65 years old - Regularly eat 3 meals/day - Be willing to refrain from drinking alcohol the day before and during test days - Have a body mass index between 18.0 and 35.0 kg/m*m - Be willing to refrain from eating after 10 pm the evening before test sessions - Be willing to participate in all study procedures Exclusion Criteria: - Must not be a smoker - Must not be an athlete in training - Must not be pregnant or breastfeeding at the time of screening - Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months - Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions) - Must not be currently dieting to gain or lose weight - Must not have a health condition that affects appetite - Must not have participated in a similar study in our lab in the past year - Must not be a student, faculty, or staff member in nutritional sciences or psychology

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low variety
Meal components are mixed together on the plate
High Variety
Meal components are served separately on the plate
Small Portion Size
Small meal portion size
Large Portion Size
Large meal portion size
With Beverage
Meal served with water
Without Beverage
Meal served without water

Locations

Country Name City State
United States Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University University Park Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University Jenny Craig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in intake by weight Weight (grams) of all meal components consumed Weeks 1, 2, 3, 4, 5, 6
Primary Change in energy intake Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density Weeks 1, 2, 3, 4, 5, 6
Secondary Change in bite count The number of bites of food during the meal Weeks 1, 2, 3, 4, 5, 6
Secondary Change in meal duration Duration of the meal in minutes Weeks 1, 2, 3, 4, 5, 6
Secondary Change in mean eating rate Mean food intake per minute (grams/minute), calculated by dividing meal food intake by meal duration Weeks 1, 2, 3, 4, 5, 6
Secondary Change in mean bite size Mean food intake per bite (grams/bite), calculated by dividing meal food intake by bite count Weeks 1, 2, 3, 4, 5, 6
Secondary Change in sip count The number of sips of water during the meal Weeks 1, 2, 3, 4, 5, 6
Secondary Change in mean drinking rate Mean water intake per minute (grams/minute), calculated by dividing meal water intake by meal duration Weeks 1, 2, 3, 4, 5, 6
Secondary Change in mean sip size Mean water intake per sip (grams/sip), calculated by dividing meal water intake by sip count Weeks 1, 2, 3, 4, 5, 6
Secondary Change in switching between bites and sips The number of switches between bites and sips during the meal Weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of pleasantness of the taste of food samples Measured on a 100-mm visual analogue scale ranging from not at all pleasant (0 mm) to extremely pleasant (100 mm). This will be used to calculate Sensory-Specific Satiety From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of prospective consumption of food samples Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) how much of [this food] do you want to eat right now?. This will be used to calculate Sensory-Specific Satiety From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of hunger Measured on a 100-mm visual analogue scale ranging from not at all hungry (0 mm) to extremely hungry (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of thirst Measured on a 100-mm visual analogue scale ranging from not at all thirsty (0 mm) to extremely thirsty (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of nausea Measured on a 100-mm visual analogue scale ranging from not at all nauseated (0 mm) to extremely nauseated (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of fullness Measured on a 100-mm visual analogue scale ranging from not at all full (0 mm) to extremely full (100 mm) From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of prospective consumption of the meal Measured on a 100-mm visual analogue scale ranging from nothing at all (0 mm) to a large amount (100 mm) in answer to the question 'How much food could you eat right now?'. At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of the size of the meal compared to participant's usual portion 100-point visual analog scale ranging from a lot smaller (0 mm) to a lot larger (100 mm) At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of how filling the participant expects this amount of food to be 100-point visual analog scale ranging from not at all filling (0 mm) to extremely filling (100 mm) At the start of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of meal termination due to fullness 100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm) At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of meal termination due to eating their usual amount 100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm) At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of meal termination due to eating is no longer a priority 100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm) At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of meal termination due to there being no food left 100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm) At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of meal termination due to self-consciousness about amount consumed 100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm) At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in rating of meal termination due to the food no longer tasting good 100-point visual analog scale ranging from strongly disagree (0 mm) to strongly agree (100 mm) At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in estimation of proportion of meal eaten 100-point visual analog scale ranging from 0% to 100% At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
Secondary Change in estimation of calories consumed at the meal Open ended question (number of calories) At the end of the test meal in weeks 1, 2, 3, 4, 5, 6
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