- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369588
Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults
February 17, 2015 updated by: Barbara J. Rolls, Penn State University
This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake.
Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal.
Some of the foods served at the meal are low in calorie density (calories per gram) and some are higher in calorie density.
The aim is to determine whether intake in response to larger portions differs depending on characteristics of the subjects or of the foods.
Study Overview
Study Type
Interventional
Enrollment (Actual)
51
Phase
- 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
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
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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
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Body mass index of 18 to 40 kg/square meter
- Regularly eat three meals per day
- Willing to eat foods served at test meals
Exclusion Criteria:
- Food allergies or restrictions
- Dieting to gain or lose weight
- Taking medications known to affect appetite
- Smoker
- Athlete in training
- Currently pregnant or breast-feeding
- Questionnaire score indicative of depression
- Questionnaire score indicative of disordered eating attitudes
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100% Portion Sizes
Food portion size Test meal consists of baseline (100%) portion size of all foods
|
|
Experimental: 133% Portion Sizes
Food portion size Test meal consists of portion sizes of all foods that are 133% the size of baseline portions
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|
Experimental: 167% Portion Sizes
Food portion size Test meal consists of portion sizes of all foods that are 167% the size of baseline portions
|
|
Experimental: 200% Portion Sizes
Food portion size Test meal consists of portion sizes of all foods that are 200% the size of baseline portions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in meal food intake
Time Frame: Weeks 1, 2, 3, and 4
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Differences in weight of food consumed (grams) at the meals
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Weeks 1, 2, 3, and 4
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Differences in meal energy intake
Time Frame: Weeks 1, 2, 3, and 4
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Differences in energy of food consumed (kilocalories) at the meals
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Weeks 1, 2, 3, and 4
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Differences in meal energy density
Time Frame: Weeks 1, 2, 3, and 4
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Differences in energy density of food consumed (kilocalories per gram) at the meal
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Weeks 1, 2, 3, and 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in hunger and satiety
Time Frame: Weeks 1, 2, 3, and 4
|
Differences in ratings of hunger and satiety either before or after the meal, as assessed by 100-mm visual analog scales (mm)
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Weeks 1, 2, 3, and 4
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Differences in ratings of food properties
Time Frame: Weeks 1, 2, 3, and 4
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Differences in ratings of food properties (such as taste or healthfulness) as assessed either by 100-mm visual analog scales (mm) or ranking (rank order)
|
Weeks 1, 2, 3, and 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbara J. Rolls, The Pennsylvania State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 17, 2015
First Submitted That Met QC Criteria
February 17, 2015
First Posted (Estimate)
February 24, 2015
Study Record Updates
Last Update Posted (Estimate)
February 24, 2015
Last Update Submitted That Met QC Criteria
February 17, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- PortionSize102
- R01DK059853 (U.S. NIH Grant/Contract)
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.
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