NCT04816955

Brief Summary

This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

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

March 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

March 17, 2021

Results QC Date

April 3, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

free sugarsdietary intakedietary recommendations

Outcome Measures

Primary Outcomes (2)

  • Free Sugar Intakes

    Percentage energy intake from free sugars, assessed using diet diaries

    12 weeks from baseline

  • Number of Participants Who Adhered to the Recommendations Provided

    Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence

    12 weeks from baseline

Secondary Outcomes (9)

  • Dietary Intakes

    12 weeks from baseline

  • BMI

    12 weeks from baseline

  • Sweet Food Preferences

    12 weeks from baseline

  • Sweet Food Choices

    12 weeks from baseline

  • Sweet Food Attitudes

    12 weeks from baseline

  • +4 more secondary outcomes

Study Arms (4)

Nutrient-based recommendations

EXPERIMENTAL

Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes.

Behavioral: Dietary recommendations

Nutrient- and food-based recommendations

EXPERIMENTAL

Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes.

Behavioral: Dietary recommendations

Nutrient- and food-based recommendations with food swaps

EXPERIMENTAL

Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes.

Behavioral: Dietary recommendations

Control

PLACEBO COMPARATOR

Participants in this group will not be given any recommendations to reduce free sugar intakes.

Behavioral: Dietary recommendations

Interventions

Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations

ControlNutrient- and food-based recommendationsNutrient- and food-based recommendations with food swapsNutrient-based recommendations

Eligibility Criteria

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

You may qualify if:

  • aged 18-65 years;
  • able to provide consent and complete all study materials;
  • consuming \>5% of TEI from free sugars; and
  • residing in the South of England.

You may not qualify if:

  • individuals who are pregnant or breastfeeding;
  • underweight (BMI \<18.5);
  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bournemouth University

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

Location

Results Point of Contact

Title
Dr Katherine Appleton
Organization
Bournemouth University

Study Officials

  • Katherine Appleton

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator, all researchers and analysts will be blinded to treatment. Participants can not masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 25, 2021

Study Start

May 1, 2021

Primary Completion

December 20, 2022

Study Completion

January 31, 2024

Last Updated

June 10, 2025

Results First Posted

June 10, 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

Locations