The Impact of Food Reformulation on Energy Intake

Sponsor
University of Liverpool (Other)
Overall Status
Recruiting
CT.gov ID
NCT05744050
Collaborator
(none)
32
1
3
3.5
9

Study Details

Study Description

Brief 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. 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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Low energy density lunch
  • Behavioral: Medium energy density lunch
  • Behavioral: High energy density lunch
N/A

Detailed Description

See attached protocol document.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Repeated measuresRepeated measures
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Impact of Food Reformulation on Energy Intake
Actual Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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)

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

Experimental: 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)

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

Experimental: 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)

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

Outcome Measures

Primary Outcome Measures

  1. Acute intake [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.

Secondary Outcome Measures

  1. Later intake [Up to 7 hours after intervention administered]

    The investigators will measure later food intake, in order to observe any evidence of later compensation in response to experimental condition.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Liverpool Liverpool Merseyside United Kingdom L69 7ZA

Sponsors and Collaborators

  • University of Liverpool

Investigators

  • Principal Investigator: Eric Robinson, PhD, University of Liverpool

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Eric Robinson, Prof., University of Liverpool
ClinicalTrials.gov Identifier:
NCT05744050
Other Study ID Numbers:
  • Reformulation study
First Posted:
Feb 24, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 24, 2023