The Impact of Food Reformulation on Energy Intake

NCT ID: NCT05744050

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2023-06-01

Brief Summary

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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

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See attached protocol document.

Conditions

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Diet, Healthy Eating Behavior Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Repeated measures
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Low energy density

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)

Group Type EXPERIMENTAL

Low energy density lunch

Intervention Type BEHAVIORAL

Particpants will be provided with a lunch low in energy density (\~1.1kcal/g)

Medium energy density

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)

Group Type EXPERIMENTAL

Medium energy density lunch

Intervention Type BEHAVIORAL

Participants will be provided with a lunch medium in energy density(\~1.7kcal/g)

High energy density

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)

Group Type EXPERIMENTAL

High energy density lunch

Intervention Type BEHAVIORAL

Participants will be provided with a lunch high in energy density (\~3kcal/g)

Interventions

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Low energy density lunch

Particpants will be provided with a lunch low in energy density (\~1.1kcal/g)

Intervention Type BEHAVIORAL

Medium energy density lunch

Participants will be provided with a lunch medium in energy density(\~1.7kcal/g)

Intervention Type BEHAVIORAL

High energy density lunch

Participants will be provided with a lunch high in energy density (\~3kcal/g)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Dietary restrictions/intolerances including:

* Any allergies
* Vegan/vegetarian
* Gluten-free
* Dairy-free
* Sugar-free
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

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Eric Robinson

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Robinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

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University of Liverpool

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38825014 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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Reformulation study

Identifier Type: -

Identifier Source: org_study_id

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