NCT06119295

Brief Summary

The present study aims to investigate whether energy intake is reduced when participants consume a reduced portion size (15% compared to the 'control' portion), and also to see whether awareness of this reduction affects energy intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

December 18, 2024

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

October 30, 2023

Last Update Submit

December 13, 2024

Conditions

Eating BehaviorObesity

Outcome Measures

Primary Outcomes (3)

  • Immediate energy intake post-fixed lunch meal

    Amount of energy consumed from the lunch dessert

    Within 30 minutes after intervention administered

  • Total delayed post-fixed lunch meal energy intake

    Amount of energy consumed from the post-lunch snack box intake, dinner meal, dinner dessert, post-dinner snack box intake, additional energy intake

    Within 10 hours after intervention administered

  • Total post-fixed lunch meal energy intake

    Amount of energy consumed from the lunch dessert, post-lunch snack box intake, dinner meal, dinner dessert, post-dinner snack box intake, additional energy intake

    Within 10 hours after intervention administered

Secondary Outcomes (2)

  • Post-lunch snack box intake

    Within 4 hours after intervention administered

  • Total intake of the ad libitum dinner meal

    Within 4-5 hours after intervention administered

Study Arms (3)

Control Condition

EXPERIMENTAL

Participants will be served a lunch - this will be of a fixed portion - this portion size will be the same amount of food as was consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).

Behavioral: Portion size manipulation

Reduce aware condition

EXPERIMENTAL

Participants will be served a lunch - this will be of a fixed portion - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served has been reduced from the amount they consumed in the baseline session).

Behavioral: Portion size manipulation

Reduced unaware condition

EXPERIMENTAL

Participants will be served a lunch - this will be of a fixed portion - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).

Behavioral: Portion size manipulation

Interventions

Portion size manipulationBEHAVIORAL

The intervention will be administered via changing portion sizes of foods served to participants. Depending on the condition participants are in, they will be served either a portion size which consists of the amount of food they consumed in the first test session, or a reduced portion size. Within these two reduced portion size conditions, one group of participants will be made aware that their portion size has been reduced, the other will not and instead will be told that this portion size is the same as the amount of food they consumed in the previous session.

Control ConditionReduce aware conditionReduced unaware condition

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • United Kingdom (UK) residents able to visit laboratory on campus in Liverpool, aged ≥ 18
  • Body Mass Index (BMI) between 18.5 and 32.5 kg/m2
  • Proficiency in English language
  • Self-report willingness to eat each of the test foods

You may not qualify if:

  • Current medication use which affects appetite
  • Pregnant
  • Currently or previously diagnosed with an eating disorder
  • Currently on a diet
  • Have any food allergies or intolerances
  • Are vegan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, L69 7ZA, United Kingdom

Location

MeSH Terms

Conditions

Feeding BehaviorObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

December 18, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

An anonymised data set will be published on the open science framework for anyone to access.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available after data collection has finished, this will be available indefinitely.

Locations

GB(1)