The Influence of Satiation Measures on the Portion Size Effect

March 11, 2020 updated by: Barbara J. Rolls, Penn State University

Lunch Feeding Study for Men and Women

The purpose of this study is to gain a better understanding of the satiation measures that influence human eating behavior in regard to intake of large portion sizes at a meal. The investigators hypothesize that satiation measures will influence the magnitude of the portion size effect at a meal. Additionally, other individual characteristics will be examined for their influence on the portion size effect. The portion size effect will be measured by serving a test meal once a week for four weeks in which the portion size of the entree will be varied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be willing and able to travel to Penn State University Park campus weekly for meals
  • Be a man or woman 18 - 70 years old
  • Regularly eat 3 meals/day
  • Be willing to avoid 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
  • Have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
  • 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
  • Have a health condition that affects appetite
  • 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 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 100% Portion Size
Test meal with portion size 100% of baseline
Other: 100% portion size
Entree portion size 100% of baseline
Experimental: 125% Portion Size
Test meal with portion size 125% of baseline
Other: 125% portion size
Entree portion size 125% of baseline
Experimental: 150% Portion Size
Test meal with portion size 150% of baseline
Other: 150% portion size
Entree portion size 150% of baseline
Experimental: 175% Portion Size
Test meal with portion size 175% of baseline
Other: 175% portion size
Entree portion size 175% of baseline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in energy intake
Time Frame: Weeks 1, 2, 3, 4
Calculated energy intake (kcal) based on weight and energy density of food consumed
Weeks 1, 2, 3, 4
Change in intake by weight
Time Frame: Weeks 1, 2, 3, 4
Weights (grams) of all foods consumed
Weeks 1, 2, 3, 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in bite count
Time Frame: Weeks 1, 2, 3, 4
The number of bites of the entree during the meal
Weeks 1, 2, 3, 4
Change in meal duration
Time Frame: Weeks 1, 2, 3, 4
Duration of the meal in seconds
Weeks 1, 2, 3, 4
Change in mean bite rate
Time Frame: Weeks 1, 2, 3, 4
Assessed from meal duration (seconds) and number of bites taken
Weeks 1, 2, 3, 4
Change in mean bite size
Time Frame: Weeks 1, 2, 3, 4
Assessed from entree intake (grams) and number of bites
Weeks 1, 2, 3, 4
Change in mean eating rate
Time Frame: Weeks 1, 2, 3, 4
Assessed from entree intake (grams) and meal duration
Weeks 1, 2, 3, 4
Change in distribution of estimated bite size
Time Frame: Weeks 1, 2, 3, 4
Assessed as small or large bites from video observation
Weeks 1, 2, 3, 4
Change in sip count
Time Frame: Weeks 1, 2, 3, 4
The number of sips of the water during the meal
Weeks 1, 2, 3, 4
Change in rating of the pleasantness of the taste of the entree sample
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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
Change in rating of the pleasantness of the taste of food samples
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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
Change in rating of prospective consumption of the entree sample
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) in answer to the question 'How much of the pasta 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
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
Measured on a 100-mm visual analogue scale ranging from none at all (0 mm) to vary large amount (100 mm) how much of the [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
Change in rating of hunger
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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
Change in rating of thirst
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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
Change in ratings of prospective consumption
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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?'.
From before the test meal to after the test meal in weeks 1, 2, 3, 4
Change in ratings of nausea
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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
Change in rating of fullness
Time Frame: From before the test meal to after the test meal in weeks 1, 2, 3, 4
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rating of the size of the entree compared to participants' usual portion
Time Frame: At the start of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from a lot smaller to a lot larger
At the start of the test meal in weeks 1, 2, 3, 4
Rating of how filling participants expect this amount of food to be
Time Frame: At the start of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from not at all filling to extremely filling
At the start of the test meal in weeks 1, 2, 3, 4
Rating of pleasantness of taste of entree
Time Frame: At the start of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from not pleasant at all to extremely pleasant
At the start of the test meal in weeks 1, 2, 3, 4
Ratings of Meal Termination due to fullness
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from strongly disagree to strongly agree
At the end of the test meal in weeks 1, 2, 3, 4
Ratings of Meal Termination due to eating their usual amount
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from strongly disagree to strongly agree
At the end of the test meal in weeks 1, 2, 3, 4
Ratings of Meal Termination due to eating is no longer a priority
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from strongly disagree to strongly agree
At the end of the test meal in weeks 1, 2, 3, 4
Ratings of Meal Termination due to there being no food left
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from strongly disagree to strongly agree
At the end of the test meal in weeks 1, 2, 3, 4
Ratings of Meal Termination due to self-consciousness about amount consumed
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from strongly disagree to strongly agree
At the end of the test meal in weeks 1, 2, 3, 4
Ratings of Meal Termination due to the food no longer tasting good
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from strongly disagree to strongly agree
At the end of the test meal in weeks 1, 2, 3, 4
Rating of proportion of meal eaten
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
100-point visual analog scale ranging from 0% to 100%
At the end of the test meal in weeks 1, 2, 3, 4
Rating of calories consumed at the meal
Time Frame: At the end of the test meal in weeks 1, 2, 3, 4
Open ended question
At the end of the test meal in weeks 1, 2, 3, 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jenny Craig, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PortionSize106

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings