Diet, HealthyNCT05744050
The Impact of Food Reformulation on Energy Intake
A study testing Low energy density lunch, Medium energy density lunch and High energy density lunch in people with Diet, Healthy and Eating Behavior, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
Food prepared outside of the home tends to have a high energy content, and high levels of nutrients of concern (sodium, fat, saturated fat and sugar), especially when compared to home-cooked food. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Eating Behavior, Obesity
- What is being tested?
- Low energy density lunch, Medium energy density lunch and High energy density lunch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2023to 1 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently reside in the United Kingdom
- Over the age of 18 years
- Fluent English speaker
- Like the test foods
- Have a BMI between the ranges of 18.5 and 35.
Who cannot join
- Pregnant/breastfeeding
- Partaking in a fast or other restrictive eating for religious reasons at time of participation
- Currently following a diet
- On medication that affects appetite
- Being a smoker
- Current or historic eating disorder
Show all 12Show fewer
- Dietary restrictions/intolerances including:
- Any allergies
- Vegan/vegetarian
- Gluten-free
- Dairy-free
- Sugar-free
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
Food prepared outside of the home tends to have a high energy content, and high levels of nutrients of concern (sodium, fat, saturated fat and sugar), especially when compared to home-cooked food. A number of studies suggest that when energy density of a food is manipulated it has a linear effect on energy intake, because consumers tend to eat a constant weight of food. However, recent observational research suggested that up to approximately 1.5-2kcal/g, individuals are relatively insensitive to changes in energy density, and there is no indication of compensation through altering meal size. However, upwards of approximately 1.5-2kcal/g, the authors proposed that individuals compensate for increases in energy density by selecting and consuming smaller meal sizes.
The investigators aim to measure participant's consumption (in grams and kilocalories) of three meals at low, medium and high energy densities, and to measure later food intake to observe any evidence of later compensation in response to experimental condition
Read the detailed description
See attached protocol document.
- Conditions
- Diet, Healthy, Eating Behavior, Obesity
- Being tested
- Low energy density lunch, Medium energy density lunch, High energy density lunch
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy density lunchBehavioural
Particpants will be provided with a lunch low in energy density (~1.1kcal/g)
Medium energy density lunchBehavioural
Participants will be provided with a lunch medium in energy density(~1.7kcal/g)
High energy density lunchBehavioural
Participants will be provided with a lunch high in energy density (~3kcal/g)
| Study group | Role | What they receive |
|---|---|---|
| Low energy density | Experimental | The meal served at lunch time to participants will have a low energy density of ~1.1kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert) Receives: Behavioral: Low energy density lunch |
| Medium energy density | Experimental | The meal served at lunch time to participants will have a low energy density of ~1.7kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert) Receives: Behavioral: Medium energy density lunch |
| High energy density | Experimental | The meal served at lunch time to participants will have a low energy density of ~3kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert) Receives: Behavioral: High energy density lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute intake
The investigators will observe differences in consumption (g/kcal) when participants are given a meal covertly manipulated to be low, medium or high in energy density.
Measured: 30 minutes after intervention administered
Secondary outcomes (1)
Later intake
The investigators will measure later food intake, in order to observe any evidence of later compensation in response to experimental condition.
Measured: Up to 7 hours after intervention administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start13 Feb 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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 Diet, HealthyStudies 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
- Model description
- Repeated measures
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Robinson, University of Liverpool
- Investigators
- Eric Robinson, PhD, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744050
- Sponsor's protocol ID
- Reformulation study
- Status last verified
- Jun 2024
- First submitted
- 10 Feb 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data (anonymised) will be shared on the Open Science Framework (OSF)
Publications
Finlay AH, Boyland EJ, Jones A, Langfield T, Bending E, Malhi MS, Robinson E. Passive overconsumption? Limited evidence of compensation in meal size when consuming foods high in energy density: Two randomised crossover experiments. Appetite. 2024 Sep 1;200:107533. doi: 10.1016/j.appet.2024.107533. Epub 2024 Jun 1.
PubMed 38825014
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Food Reformulation on Energy Intake
- ClinicalTrials.gov ID
- NCT05744050
- Acronym / sponsor ID
- Reformulation study
- Conditions
- Diet, Healthy, Eating Behavior, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 24 Feb 2023 (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.
Food prepared outside of the home tends to have a high energy content, and high levels of nutrients of concern (sodium, fat, saturated fat and sugar), especially when compared to home-cooked food. A number of studies suggest that when energy density of a food is manipulated it has a linear effect on energy intake, because consumers tend to eat a constant weight of food. However, recent observational research suggested that up to approximately 1.5-2kcal/g, individuals are relatively insensitive to changes in energy density, and there is no indication of compensation through altering meal size. However, upwards of approximately 1.5-2kcal/g, the authors proposed that individuals compensate for increases in energy density by selecting and consuming smaller meal sizes.
The investigators aim to measure participant's consumption (in grams and kilocalories) of three meals at low, medium and high energy densities, and to measure later food intake to observe any evidence of later compensation in response to experimental condition
Detailed description
See attached protocol document.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Repeated measures
| Arm | Type | Receives |
|---|---|---|
| Low energy density | Experimental | Behavioral: Low energy density lunchThe meal served at lunch time to participants will have a low energy density of ~1.1kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert) |
| Medium energy density | Experimental | Behavioral: Medium energy density lunchThe meal served at lunch time to participants will have a low energy density of ~1.7kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert) |
| High energy density | Experimental | Behavioral: High energy density lunchThe meal served at lunch time to participants will have a low energy density of ~3kcal/g. All other foods are identical across conditions (e.g. snacks, dinner, dessert) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently reside in the United Kingdom
- Over the age of 18 years
- Fluent English speaker
- Like the test foods
- Have a BMI between the ranges of 18.5 and 35.
Key exclusion criteria (12 listed)
- Pregnant/breastfeeding
- Partaking in a fast or other restrictive eating for religious reasons at time of participation
- Currently following a diet
- On medication that affects appetite
- Being a smoker
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 |
|---|---|---|
| Low energy density lunchParticpants will be provided with a lunch low in energy density (~1.1kcal/g) | Behavioural | Low energy density |
| Medium energy density lunchParticipants will be provided with a lunch medium in energy density(~1.7kcal/g) | Behavioural | Medium energy density |
| High energy density lunchParticipants will be provided with a lunch high in energy density (~3kcal/g) | Behavioural | High energy density |
Primary outcome
Acute intake
Time frame: 30 minutes after intervention administered
The investigators will observe differences in consumption (g/kcal) when participants are given a meal covertly manipulated to be low, medium or high in energy density.
1 secondary outcome
Later intake
Time frame: Up to 7 hours after intervention administered
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 5 Jun 2024.
- Derived from this study: PubMed 38825014Finlay AH, Boyland EJ, Jones A, Langfield T, Bending E, Malhi MS, Robinson E. Passive overconsumption? Limited evidence of compensation in meal size when consuming foods high in energy density: Two randomised crossover experiments. Appetite. 2024 Sep 1;200:107533. doi: 10.1016/j.appet.2024.107533. Epub 2024 Jun 1.
- Individual participant dataSharing planned: Yes. Study data (anonymised) will be shared on the Open Science Framework (OSF)
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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.
Eric Robinson, PhD principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy density lunch, Medium energy density lunch and High energy density lunch in people with Diet, Healthy and Eating Behavior, 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 5 inclusion and 12 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 5 Jun 2024. 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 intake (time frame: 30 minutes after intervention administered). 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 NCT05744050, 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 5 Jun 2024.