- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03409601
The Role of Satiety in the Effect of Portion Size on Intake
March 14, 2019 updated by: Barbara J. Rolls, Penn State University
The study uses a crossover design in which the portion size of food is varied at each meal.
Across four test meals, subjects will be served four different portions of food, and intake will be determined from pre- and post-meal food weights.
The first visit will be a screening visit, at which subjects will complete the consent form, have their height and weight measured, and rate the taste of the study food.
Test meals will be scheduled once a week for four weeks.
At visits 2-5, subjects will eat lunch and rate characteristics of the meal.
At visit 6, subjects will complete various questionnaires.
The objective of this study is to determine whether any individual characteristics related to satiety influence the effect of portion size on intake.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
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
Ages Eligible for Study
20 years to 65 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 - 60 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-squared
- Be willing to refrain from eating after 10 pm the evening before test sessions
Exclusion Criteria:
- A smoker
- An athlete in training
- 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)
- 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
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 100% Portion Size
Test meal consists of baseline (100%) portion size of meal.
|
Meal portion size at baseline
|
EXPERIMENTAL: 125% Portion Size
Test meal consists of food portion size that is 125% the size of baseline portion.
|
Meal portion size 125% of baseline
|
EXPERIMENTAL: 150% Portion Size
Test meal consists of food portion size that is 150% the size of baseline portion.
|
Meal portion size 150% of baseline
|
EXPERIMENTAL: 175% Portion Size
Test meal consists of food portion size that is 175% the size of baseline portion.
|
Meal portion size 175% of baseline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in energy intake
Time Frame: Weeks 1, 2, 3, and 4
|
Calculated energy intake (kcal) based on weight and energy density of food consumed
|
Weeks 1, 2, 3, and 4
|
Differences in intake by weight
Time Frame: Weeks 1, 2, 3, and 4
|
Weights (grams) of all foods consumed
|
Weeks 1, 2, 3, and 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory-specific satiety
Time Frame: Weeks 1, 2, 3, and 4
|
Change in taste pleasantness of eaten foods compared to uneaten foods
|
Weeks 1, 2, 3, and 4
|
Eating rate
Time Frame: Weeks 1, 2, 3, and 4
|
Assessed from meal duration and number of bites taken
|
Weeks 1, 2, 3, and 4
|
Ratings of hunger and satiety
Time Frame: Weeks 1, 2, 3, and 4
|
100-point visual analog scales
|
Weeks 1, 2, 3, and 4
|
Ratings of sensory characteristics of the food
Time Frame: Weeks 1, 2, 3, and 4
|
100-point visual analog scales
|
Weeks 1, 2, 3, and 4
|
Ratings of meal characteristics
Time Frame: Weeks 1, 2, 3, and 4
|
100-point visual analog scales
|
Weeks 1, 2, 3, and 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 2, 2018
Primary Completion (ACTUAL)
December 14, 2018
Study Completion (ACTUAL)
December 14, 2018
Study Registration Dates
First Submitted
January 18, 2018
First Submitted That Met QC Criteria
January 18, 2018
First Posted (ACTUAL)
January 24, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2019
Last Update Submitted That Met QC Criteria
March 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- PortionSize104
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.
Clinical Trials on Feeding Behavior
-
Centre Hospitalier Intercommunal CreteilCompletedFeeding Behavior | Feeding, BottleFrance
-
Sakarya UniversityNot yet recruitingBreast Feeding | Feeding BehaviorTurkey
-
Taipei Medical UniversityCompletedBreast Feeding | Self Efficacy | Feeding BehaviorIndonesia
-
The University of Tennessee, KnoxvilleWithdrawnFeeding Behavior | Behavior | Food Habits | Behavior and Behavior MechanismsUnited States
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedFeeding BehaviorUnited States
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); United...Completed
-
University of Colorado, DenverTemple University; Vitamix FoundationRecruiting
-
Penn State UniversityJenny Craig, Inc.Completed
-
Iowa State UniversityCompleted
Clinical Trials on 100% Portion Size
-
Penn State UniversityJenny Craig, Inc.Completed
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedFeeding BehaviorUnited States
-
University of LiverpoolCompletedEating Behavior
-
University of AlbertaCompleted
-
Columbia UniversityRecruitingEating Behavior | Shift Work Type Circadian Rhythm Sleep DisorderUnited States
-
University of LiverpoolMedical Research CouncilCompletedPortion SizeUnited Kingdom
-
University of LiverpoolMedical Research CouncilCompleted
-
University of LiverpoolEuropean Research CouncilCompletedObesity | Diet, Healthy | Eating BehaviorUnited Kingdom
-
Penn State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedFeeding BehaviorsUnited States
-
Temple UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed