Portion SizeNCT03811210
Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation Over 5 Days
A study testing portion size in people with Portion Size, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Portion Size
- What is being tested?
- portion size
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2018to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- willing to consume the test foods
- BMI between 22.5 - 32.5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Portion Size
- Being tested
- portion size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portion sizeBehavioural
Smaller than normal portion size - the intervention is the main meal component size perceived as 'smaller than normal' that participants are provided with during lunch and dinner in the laboratory.
Small-normal portion size - the intervention is the main meal component size perceived as 'small-normal' that participants are provided with during lunch and dinner in the laboratory.
Large-normal portion size - the intervention is the main meal component size perceived as 'large-normal' that participants are provided with during lunch and dinner in the laboratory.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute compensatory energy intake
Energy intake from main meal components that are not varied by portion size
Measured: Immediate (within single meal occasion)
Total meal energy intake
Energy intake from all main meal components (including those that are and are not varied by portion size)
Measured: Immediate (within single meal occasion)
Total daily energy intake
Energy intake from all foods consumed, including those provided in the laboratory and those self-reported
Measured: Over 5 x full days
Secondary outcomes (3)
Moderate-vigorous physical activity
Moderate-vigorous physical activity (recorded using accelerometer device)
Measured: Over 5 x full days
Discretionary Leisure-time physical activity
Discretionary Leisure-time physical activity (recorded with self-report measure International Physical Activity Questionnaire)
Measured: Over 5 x full days
Appetite
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')
Measured: Over 5 x full days (measured before and after each meal occasion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start6 Feb 2018
- Primary completion7 Dec 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Portion SizeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Eric Robinson, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811210
- Sponsor's protocol ID
- Portion size trial
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for primary outcome measures, demographic variables, and data reported in resulting publication will be made freely available on Open Science Framework
Publications
Haynes A, Hardman CA, Halford JCG, Jebb SA, Mead BR, Robinson E. Reductions to main meal portion sizes reduce daily energy intake regardless of perceived normality of portion size: a 5 day cross-over laboratory experiment. Int J Behav Nutr Phys Act. 2020 Feb 12;17(1):21. doi: 10.1186/s12966-020-0920-4.
PubMed 32050979
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation
- ClinicalTrials.gov ID
- NCT03811210
- Acronym / sponsor ID
- Portion size trial
- Conditions
- Portion Size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- willing to consume the test foods
- BMI between 22.5 - 32.5
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| portion sizeSmaller than normal portion size - the intervention is the main meal component size perceived as 'smaller than normal' that participants are provided with during lunch and dinner in the laboratory. Small-normal portion size - the intervention is the main meal component size perceived as 'small-normal' that participants are provided with during lunch and dinner in the laboratory. Large-normal portion size - the intervention is the main meal component size perceived as 'large-normal' that participants are provided with during lunch and dinner in the laboratory. | Behavioural | – |
Primary outcome
Acute compensatory energy intake
Time frame: Immediate (within single meal occasion)
Energy intake from main meal components that are not varied by portion size
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)
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
3 secondary outcomes
Moderate-vigorous physical activity
Time frame: Over 5 x full days
Discretionary Leisure-time physical activity
Time frame: Over 5 x full days
Appetite
Time frame: Over 5 x full days (measured before and after each meal occasion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Derived from this study: PubMed 32050979Haynes A, Hardman CA, Halford JCG, Jebb SA, Mead BR, Robinson E. Reductions to main meal portion sizes reduce daily energy intake regardless of perceived normality of portion size: a 5 day cross-over laboratory experiment. Int J Behav Nutr Phys Act. 2020 Feb 12;17(1):21. doi: 10.1186/s12966-020-0920-4.
- Individual participant dataSharing planned: Yes. IPD for primary outcome measures, demographic variables, and data reported in resulting publication will be made freely available on Open Science Framework
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portion size in people with Portion Size, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute compensatory energy intake (time frame: Immediate (within single meal occasion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.