NCT05932329

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 Jul 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

June 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
6 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

6 months

First QC Date

June 27, 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 4

  • Adherence

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

    Baseline to week 4

Secondary Outcomes (13)

  • Dietary Intakes

    Baseline to week 4

  • Body weight

    Baseline to week 4

  • BMI

    Baseline to week 4

  • Waist circumference

    Baseline to week 4

  • Body fat percentage

    Baseline to week 4

  • +8 more secondary outcomes

Study Arms (3)

Sweet Taste

ACTIVE COMPARATOR

The intervention will be provided to participants in written form, in an opaque sealed envelope.

Behavioral: Dietary Advice

Taste

ACTIVE COMPARATOR

The intervention will be provided to participants in written form, in an opaque sealed envelope.

Behavioral: Dietary Advice

No Taste

ACTIVE COMPARATOR

The intervention will be provided to participants in written form, in an opaque sealed envelope.

Behavioral: Dietary Advice

Interventions

Dietary AdviceBEHAVIORAL

Dietary Advice provided

No TasteSweet TasteTaste

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

Related Links

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
All researchers in contact with participants will be blinded, and all analysts.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized intervention design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

July 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 data will be shared with other researchers on reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
From publication of the results

Locations