Reducing Free Sugar Intakes: A Role for Sweet Taste II

June 22, 2026 updated by: Bournemouth University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this randomised controlled trial is to assess the effects of three different types of dietary advice, for reducing total energy intakes (TEI) of free sugars. A total of 150 participants (age 18-65 years) consuming diets >5% total energy intake from dietary free sugars will be recruited from across the Dorset region. All participants will be asked to reduce their free sugar intake to <5% TEI, and to aid with this, they will be encouraged to reduce their intakes of specific foods identified as high in free sugars. Participants will also be advised to replace these foods with other foods dependent on their taste. Participants will be randomised to replace high sugar foods with: 1) foods that are low in sugars, but high in sweet taste; 2) food that are low in sugars, but high in other tastes; and 3) foods that are low in taste. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 4. Secondary outcomes will include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetened food intakes and adherence levels at week 4.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. aged 18-65 years;
  2. able to provide consent and complete all study materials;
  3. consuming >5% of TEI from free sugars;
  4. residing in the South of England, and able to attend Bournemouth University for testing.

Exclusion Criteria:

  1. individuals who are pregnant or breastfeeding;
  2. underweight (BMI <18.5);
  3. 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;
  4. have pre-existing medical conditions affecting swallow ability, taste and smell perception;
  5. currently following a specific dietary programme (e.g.: Slimming World);
  6. current smokers or have smoked within 3 months of the study start date.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sweet Taste
The intervention will be provided to participants in written form, in an opaque sealed envelope.
Behavioral: Dietary Advice
Dietary Advice provided
Active Comparator: Taste
The intervention will be provided to participants in written form, in an opaque sealed envelope.
Behavioral: Dietary Advice
Dietary Advice provided
Active Comparator: No Taste
The intervention will be provided to participants in written form, in an opaque sealed envelope.
Behavioral: Dietary Advice
Dietary Advice provided

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Free sugar intakes
Time Frame: Baseline to week 4
Percentage energy intake from free sugars, assessed using diet diaries
Baseline to week 4
Adherence
Time Frame: Baseline to week 4
Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence
Baseline to week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary Intakes
Time Frame: Baseline to week 4
Nutrient composition and taste of dietary intakes, assessed using diet diaries
Baseline to week 4
Body weight
Time Frame: Baseline to week 4
Body weight, in kg, assessed using researcher measurements
Baseline to week 4
BMI
Time Frame: Baseline to week 4
BMI, in kg/m2, assessed using researcher measurements
Baseline to week 4
Waist circumference
Time Frame: Baseline to week 4
Waist circumference, in cm, assessed using researcher measurements
Baseline to week 4
Body fat percentage
Time Frame: Baseline to week 4
Body fat percentage, assessed using bioimpedence, as conducted by the researcher measurements
Baseline to week 4
Sweet food preferences
Time Frame: Baseline to week 4
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. Higher scores signify stronger preferences
Baseline to week 4
Sweet food perceptions
Time Frame: Baseline to week 4
Perceptions of the strength of sweet taste for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for strength of taste on a 100mm Visual Analogue Scale. Higher scores signify stronger perceptions
Baseline to week 4
Sweet food intakes
Time Frame: Baseline to week 4
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 in terms of weight consumed
Baseline to week 4
Sweet food attitudes
Time Frame: Baseline to week 4
Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published. Higher scores denote stronger attitudes.
Baseline to week 4
Adverse events
Time Frame: Baseline to week 4
Adverse events, assessed by self-report
Baseline to week 4
Eating-based attitudes
Time Frame: Baseline to week 4
Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)
Baseline to week 4
Subjective Quality of Life
Time Frame: Baseline to week 4
Quality of Life, measured using the SF-36 questionnaire (Ware et al, 1996), where Quality of Life is assessed out of 100, where a higher score demonstrates better quality of life
Baseline to week 4
Barriers and facilitators to success
Time Frame: Baseline to week 4
An assessment of barriers and facilitators to success, assessed by self-report questionnaire
Baseline to week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bournemouth University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine M Appleton, Bournemouth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RFSII2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

From publication of the results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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