- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811210
Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation Over 5 Days
January 22, 2019 updated by: Eric Robinson, University of Liverpool
Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation
Reducing food portion size is a potential strategy to reduce energy intake.
However it is unclear at what point consumers compensate for reductions in portion size by increasing energy intake from other items.
This could result in no overall benefit of reducing food portion sizes.
The investigators tested the hypothesis that reductions to the portion size of components of a main meal will only result in significant compensatory eating when the reduced portion size is no longer visually perceived as 'normal'.
In a crossover experiment, participants were served different sized portions during lunch and dinner over 5 days: a 'large-normal', a 'small-normal', and a 'smaller than normal' portion.
Intake from all other meal components consumed in the laboratory were measured.
Study Overview
Study Type
Interventional
Enrollment (Actual)
39
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
-
-
Merseyside
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Liverpool, Merseyside, United Kingdom, L3 6AA
- Ashleigh Haynes
-
-
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
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- willing to consume the test foods
- BMI between 22.5 - 32.5
Exclusion Criteria:
- food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
- history of eating disorders
- taking medication which affected appetite
- participated in a portion size studies in the past 12 months, or in dieting or weight loss trials in the past 4 weeks
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute compensatory energy intake
Time Frame: Immediate (within single meal occasion)
|
Energy intake from main meal components that are not varied by portion size
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Immediate (within single meal occasion)
|
|
Total meal energy intake
Time Frame: Immediate (within single meal occasion)
|
Energy intake from all main meal components (including those that are and are not varied by portion size)
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Immediate (within single meal occasion)
|
|
Total daily energy intake
Time Frame: Over 5 x full days
|
Energy intake from all foods consumed, including those provided in the laboratory and those self-reported
|
Over 5 x full days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderate-vigorous physical activity
Time Frame: Over 5 x full days
|
Moderate-vigorous physical activity (recorded using accelerometer device)
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Over 5 x full days
|
|
Discretionary Leisure-time physical activity
Time Frame: Over 5 x full days
|
Discretionary Leisure-time physical activity (recorded with self-report measure International Physical Activity Questionnaire)
|
Over 5 x full days
|
|
Appetite
Time Frame: Over 5 x full days (measured before and after each meal occasion)
|
Hunger and fullness sensations before and after laboratory-based meals (self-reported on visual analog scales anchored at 0 'not at all' to 100 'extremely')
|
Over 5 x full days (measured before and after each meal occasion)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (ACTUAL)
February 6, 2018
Primary Completion (ACTUAL)
December 7, 2018
Study Completion (ACTUAL)
December 10, 2018
Study Registration Dates
First Submitted
January 17, 2019
First Submitted That Met QC Criteria
January 17, 2019
First Posted (ACTUAL)
January 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 24, 2019
Last Update Submitted That Met QC Criteria
January 22, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Portion size trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD for primary outcome measures, demographic variables, and data reported in resulting publication will be made freely available on Open Science Framework
IPD Sharing Time Frame
Study protocol and statistical analysis plan, along with IPD data will be made publicly available on Open Science Framework when results are published
IPD Sharing Access Criteria
Data will be freely accessible.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.
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