Clinical trial NCT05177367: Combined Effects of Variety and Portion Size on Meal Intake of Women
Official title: Combined Effects of Variety and Portion Size on Meal Intake of Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Eating Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Jenny Craig, Inc.
First posted: 2022-01-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to investigate the combined effects of meal variety and portion size on food intake at a meal. The study will also investigate 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.


Eligibility criteria: 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 have a high variability in liking of the test foods
* 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

Primary outcomes:
measure: Change in intake by weight
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in energy intake
timeFrame: Weeks 1, 2, 3, 4, 5, 6
Secondary outcomes:
measure: Change in bite count
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in meal duration
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in mean eating rate
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in mean bite size
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in sip count
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in mean drinking rate
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in mean sip size
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in switching between bites and sips
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in switching between different foods
timeFrame: Weeks 1, 2, 3, 4, 5, 6
measure: Change in rating of pleasantness of the taste of food samples
timeFrame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
measure: Change in rating of prospective consumption of food samples
timeFrame: Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
measure: Change in rating of hunger
timeFrame: Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
measure: Change in rating of thirst
timeFrame: Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
measure: Change in rating of nausea
timeFrame: Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
measure: Change in rating of fullness
timeFrame: Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6
Other outcomes:
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
state: Pennsylvania
Study officials:
References: