NCT05684757

Brief Summary

This randomised controlled trial aims to assess the effects of three different types of dietary advice for reducing free sugar intakes, on intakes of free sugar, in a sample of the UK population.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

January 3, 2023

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Free sugar intakes

    Percentage energy intake from free sugars, assessed using diet diaries

    Baseline to week 12

  • Adherence

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

    Baseline to week 12

Secondary Outcomes (13)

  • Dietary Intakes

    Baseline to week 12

  • Body weight

    Baseline to week 12

  • BMI

    Baseline to week 12

  • Waist circumference

    Baseline to week 12

  • Body fat percentage

    Baseline to week 12

  • +8 more secondary outcomes

Study Arms (3)

Dietary Advice: Sweet Taste

ACTIVE COMPARATOR

Participants will be asked to reduce their free sugar intakes to less than 5% TEI. To aid with this, they will be asked to reduce their intakes of foods and drinks high in free sugars, and replace these with foods low in sugars, that remain high in sweet taste, eg. fruit, low-calorie sweetened foods and drinks. The intervention will be provided to participants in written form, in an opaque sealed envelope.

Behavioral: Dietary Advice

Dietary Advice: Taste

ACTIVE COMPARATOR

Participants will be asked to reduce their free sugar intakes to less than 5% TEI. To aid with this, they will be asked to reduce their intakes of foods and drinks high in free sugars, and replace these with foods low in sugars, that remain high in taste, eg. nuts, foods and drinks flavoured with herbs and spices. The intervention will be provided to participants in written form, in an opaque sealed envelope.

Behavioral: Dietary Advice

Dietary Advice: No taste

ACTIVE COMPARATOR

Participants will be asked to reduce their free sugar intakes to less than 5% TEI. To aid with this, they will be asked to reduce their intakes of foods and drinks high in free sugars, and replace these with foods low in sugars, that are low in taste, eg. foods and drinks that are plain-flavoured, wholegrains. The intervention will be provided to participants in written form, in an opaque sealed envelope.

Behavioral: Dietary Advice

Interventions

Dietary AdviceBEHAVIORAL

Dietary Advice

Dietary Advice: No tasteDietary Advice: Sweet TasteDietary Advice: Taste

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;
  • residing in the South of England, and 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 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

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Katherine M Appleton

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 13, 2023

Study Start

March 1, 2023

Primary Completion

December 22, 2023

Study Completion

July 31, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

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
Reasonable request

Locations