The Impact of Food Reformulation on Energy Intake

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

Study Overview

• Status: Completed
• Conditions: Obesity; Diet, Healthy; Eating Behavior
• Intervention / Treatment: Behavioral: Low energy density lunch; Behavioral: Medium energy density lunch; Behavioral: High energy density lunch

Detailed Description

See attached protocol document.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L69 7ZA
      • University of Liverpool

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes after intervention administered

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Later intake	The investigators will measure later food intake, in order to observe any evidence of later compensation in response to experimental condition.	Up to 7 hours after intervention administered

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Reformulation study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data (anonymised) will be shared on the Open Science Framework (OSF)
• IPD Sharing Time Frame: On publication, indefinitely
• IPD Sharing Access Criteria: Open website
• 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