NCT05744050

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

February 10, 2023

Last Update Submit

June 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Later intake

    Up to 7 hours after intervention administered

Study Arms (3)

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)

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)

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)

Behavioral: High energy density lunch

Interventions

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

Low energy density

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

Medium energy density

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

High energy density

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L69 7ZA, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding BehaviorObesity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Robinson, PhD

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Repeated measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 24, 2023

Study Start

February 13, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

June 5, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Study data (anonymised) will be shared on the Open Science Framework (OSF)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
On publication, indefinitely
Access Criteria
Open website
More information

Locations