NCT05672017

Brief Summary

This study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration 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

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 26, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

January 3, 2023

Results QC Date

April 3, 2025

Last Update Submit

June 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sweet Food Preferences

    Preferences for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for pleasantness on a 100mm Visual Analogue Scale, from 0 to 100mm. Higher scores signify stronger preferences

    Week 1

  • Sweet Food Choices

    Selection of sweet foods/fluids at a given meal, assessed where participants can consume freely from a meal composed of sweet and non-sweet foods, and proportion of sweet foods consumed is measured as a percentage of weight consumed

    Week 1

Secondary Outcomes (4)

  • Hunger and Thirst

    Week 1

  • Sweet Food Perceptions

    Week 1

  • MRI Static Brain Scan (Subset of Participants Only)

    Baseline to week 1

  • fMRI Composite Functional Brain Scan (Subset of Participants Only)

    Baseline to week 1

Study Arms (3)

Dietary Instructions: Increase sweet food consumption

ACTIVE COMPARATOR

Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and additional means of increasing sweet food consumption will be offered.

Behavioral: Dietary Instructions

Dietary Instructions: Decrease sweet food consumption

ACTIVE COMPARATOR

Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and means of decreasing sweet food consumption will be offered.

Behavioral: Dietary Instructions

Dietary Instructions: Usual Diet

PLACEBO COMPARATOR

Participants are asked to retain their consumption of sweet foods throughout their diet.

Behavioral: Dietary Instructions

Interventions

Dietary Instructions

Dietary Instructions: Decrease sweet food consumptionDietary Instructions: Increase sweet food consumptionDietary Instructions: Usual Diet

Eligibility Criteria

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

You may qualify if:

  • aged 18-65 years;
  • habitually consume breakfast;
  • able to provide consent and complete all study materials;
  • able to attend Bournemouth University for testing.

You may not qualify if:

  • individuals who are pregnant or breastfeeding;
  • underweight (BMI \<18.5);
  • have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions;
  • have pre-existing medical conditions affecting swallow ability, taste and smell perception;
  • currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
  • current smokers or have smoked within 3 months of the study start date.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bournemouth University

Bournemouth, US and Canada Only, BH12 5BB, United Kingdom

Location

Related Publications (1)

  • This project is associated with Clinical Trails Registration: NCT03427658

    BACKGROUND

Results Point of Contact

Title
Dr Katherine Appleton
Organization
Bournemouth University

Study Officials

  • Katherine M Appleton

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigators, outcome assessors and analysts will be masked. It is not possible to mask participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

March 1, 2023

Primary Completion

March 31, 2024

Study Completion

December 31, 2024

Last Updated

June 26, 2025

Results First Posted

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Anonymised study data will be available on completion of the trial from the PI

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
On study completion
Access Criteria
On reasonable request

Locations