Combined Effects of Variety and Portion Size on Meal Intake of Women

Sponsor

Penn State University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05177367

Collaborator

Jenny Craig, Inc. (Industry)

Enrollment

Location

Arms

11.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Behavior	Other: Sequential Variety Other: Simultaneous Variety Other: Single Food Other: Small portion Other: Large Portion	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Combined Effects of Variety and Portion Size on Meal Intake of Women

Anticipated Study Start Date :

Feb 20, 2022

Anticipated Primary Completion Date :

Jan 20, 2023

Anticipated Study Completion Date :

Jan 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequential Variety, Small Portion 3 courses each consisting of a different food served in a small portion.	Other: Sequential Variety 3 courses each consisting of a different food Other: Small portion Small meal portion size
Experimental: Sequential Variety, Large Portion 3 courses each consisting of a different food served in a large portion.	Other: Sequential Variety 3 courses each consisting of a different food Other: Large Portion Large meal portion size
Experimental: Simultaneous Variety, Small Portion 3 courses each consisting of 3 foods served in small portions.	Other: Simultaneous Variety 3 courses each consisting of 3 foods Other: Small portion Small meal portion size
Experimental: Simultaneous Variety, Large Portion 3 courses each consisting of 3 foods served in large portions.	Other: Simultaneous Variety 3 courses each consisting of 3 foods Other: Large Portion Large meal portion size
Experimental: Single Food, Small Portion 3 courses each consisting of the same food served in a small portion.	Other: Single Food 3 courses each consisting of the same food Other: Small portion Small meal portion size
Experimental: Single Food, Large Portion 3 courses each consisting of the same food served in a large portion.	Other: Single Food 3 courses each consisting of the same food Other: Large Portion Large meal portion size

Outcome Measures

Primary Outcome Measures

Change in intake by weight [Weeks 1, 2, 3, 4, 5, 6]
Weight (grams) of all meal components consumed
Change in energy intake [Weeks 1, 2, 3, 4, 5, 6]
Energy intake (kilocalories) of all meal components consumed, calculated from weight and energy density

Secondary Outcome Measures

Change in bite count [Weeks 1, 2, 3, 4, 5, 6]
The number of bites of food during the meal
Change in meal duration [Weeks 1, 2, 3, 4, 5, 6]
Duration of the meal in minutes
Change in mean eating rate [Weeks 1, 2, 3, 4, 5, 6]
Mean food intake per minute (grams/minute), calculated by dividing meal food intake by meal duration
Change in mean bite size [Weeks 1, 2, 3, 4, 5, 6]
Mean food intake per bite (grams/bite), calculated by dividing meal food intake by bite count
Change in sip count [Weeks 1, 2, 3, 4, 5, 6]
The number of sips of water during the meal
Change in mean drinking rate [Weeks 1, 2, 3, 4, 5, 6]
Mean water intake per minute (grams/minute), calculated by dividing meal water intake by meal duration
Change in mean sip size [Weeks 1, 2, 3, 4, 5, 6]
Mean water intake per sip (grams/sip), calculated by dividing meal water intake by sip count
Change in switching between bites and sips [Weeks 1, 2, 3, 4, 5, 6]
The number of switches between bites and sips during the meal
Change in switching between different foods [Weeks 1, 2, 3, 4, 5, 6]
The number of switches between different foods
Change in rating of pleasantness of the taste of food samples [From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6]
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
Change in rating of prospective consumption of food samples [Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6]
Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to a very large amount (100 mm), in answer to "How much of [this food] do you want to eat right now?". This will be used to calculate Sensory-Specific Satiety
Change in rating of hunger [Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6]
Measured on a 100-mm visual analogue scale ranging from not at all hungry (0 mm) to extremely hungry (100 mm)
Change in rating of thirst [Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6]
Measured on a 100-mm visual analogue scale ranging from not at all thirsty (0 mm) to extremely thirsty (100 mm)
Change in rating of nausea [Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6]
Measured on a 100-mm visual analogue scale ranging from not at all nauseated (0 mm) to extremely nauseated (100 mm)
Change in rating of fullness [Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4, 5, 6]
Measured on a 100-mm visual analogue scale ranging from not at all full (0 mm) to extremely full (100 mm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University	University Park	Pennsylvania	United States	16802

Sponsors and Collaborators

Penn State University
Jenny Craig, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Barbara J. Rolls, Professor of Nutrition and Director of The Laboratory For The Study of Human Ingestive Behavior, Penn State University

ClinicalTrials.gov Identifier:

NCT05177367

Other Study ID Numbers:

FoodVariety102

First Posted:

Jan 4, 2022

Last Update Posted:

Mar 4, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 4, 2022