- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925932
This Trial Aims to Assess the Effects of Three Different Taste-based Dietary Recommendations for Reducing Free Sugar Intakes on Free Sugar Consumption in UK High Free Sugar Consumers
June 9, 2025 updated by: Bournemouth University
Reducing Free Sugar Intakes - The Role of Sweet Taste III
This randomised controlled trial aims to assess the effects of three different taste-based dietary recommendations for reducing free sugar intakes on free sugar consumption in UK high free sugar consumers.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
This 12-week, 3-arm randomised controlled trial aims to assess the effects of three different taste-based food and beverage substitution instructions for reducing free sugar intakes on free sugar consumption in high free sugar consumers.
A total of 180 adult community members residing in Bournemouth and the surrounding areas will be recruited.
All participants will be asked to reduce their intakes of free sugar and replace sweet, high-free sugar foods and beverages with either: 1) sweet tasting foods and beverages that have no or low amounts of free sugars; 2) non-sweet tasting foods and beverages that have no or low amounts of free sugars and are high in other tasty flavours; and 3) non-sweet tasting foods and beverages that have no or low amounts of free sugars and are also low in other flavours.
The primary outcome of interest is the changes in free sugar intakes from baseline to endpoint.
Secondary outcomes include a range of dietary and biopsychosocial outcomes, sweet taste perceptions and sweet food and beverage intakes, as well as compliance with and evaluation of the dietary recommendation received.
Study Type
Interventional
Enrollment (Estimated)
180
Phase
- 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 Locations
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-
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Bournemouth, United Kingdom, BH12 5BB
- Bournemouth University
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 18 and over
- Consuming more than 10% total daily energy from free sugars (-3% for testing error)
- Residing in the South of England, and able to attend Bournemouth University for testing (Talbot Campus, BH12 5BB)
- Able to provide consent and complete all study-related measures
Exclusion Criteria:
- Being a smoker or having smoked in the last 3 months
- Being pregnant or breastfeeding
- Being underweight (BMI < 18.5 kg/m²)
- Dieting or following a specific diet program (e.g., Weight Watchers, Keto diet, or Intermittent Fasting)
- Following a specific diet or nutritional advice as a result of pre-existing medical condition (e.g., Crohn's disease, diabetes)
- Having a pre-existing medical condition or taking medication that could affect taste and/or smell abilities (e.g., certain blood pressure and heart medications)
- Allergies to foods and drinks used in the study
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Sweet taste arm
Description: Participants in this arm will be asked to reduce their free sugar intakes to < 5%TEI and replace sweet foods and drinks that are high in free sugars with foods and drinks that are sweet but have no or low amounts of free sugars, e.g., sweet no- or low-free sugar foods, fruit, and no- or low-calorie sweeteners.
|
Asked to reduce their free sugar intakes to < 5%TEI and replace sweet foods and drinks that are high in free sugars with foods and drinks that are sweet but have no or low amounts of free sugars, e.g., sweet no- or low-free sugar foods, fruit, and no- or low-calorie sweeteners.
|
|
Active Comparator: Taste arm
Description: Participants in this arm will be asked to reduce their free sugar intakes to < 5%TEI and replace sweet foods and drinks that are high in free sugars with foods and drinks that are non-sweet but are full of tasty flavours, e.g., non-sweet foods and drinks with nuts, herbs or spices.
|
Asked to reduce their free sugar intakes to < 5%TEI and replace sweet foods and drinks that are high in free sugars with foods and drinks that are non-sweet but are full of tasty flavours, e.g., non-sweet foods and drinks with nuts, herbs or spices.
|
|
Active Comparator: No taste arm
Description: Participants in this arm will be asked to reduce their free sugar intakes to < 5%TEI and replace sweet foods and drinks that are high in free sugars with foods and drinks that are non-sweet and have no strong flavours, e.g., non-sweet plain foods and drinks.
|
Asked to reduce their free sugar intakes to < 5%TEI and replace sweet foods and drinks that are high in free sugars with foods and drinks that are non-sweet and have no strong flavours, e.g., non-sweet plain foods and drinks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Free sugar intakes
Time Frame: Baseline to week 12
|
Percentage total energy intake (%TEI) from free sugars, measured using multiple 24-hour dietary recalls.
|
Baseline to week 12
|
|
Adherence
Time Frame: week 3 to week 12
|
Adherence with the dietary advice received will be assessed by self-report using online surveys.
|
week 3 to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy intake and diet composition
Time Frame: Baseline to week 12
|
Energy intake and nutrient composition of dietary intakes, measured using multiple 24-hour dietary recalls.
|
Baseline to week 12
|
|
Body weight
Time Frame: Baseline to week 12
|
Weight, in kilograms, assessed using standard digital scales.
|
Baseline to week 12
|
|
Waist circumference
Time Frame: Baseline to week 12
|
Waist circumference, in centimeters, measured using standard flexible tape measure.
|
Baseline to week 12
|
|
Body fat percentage
Time Frame: Baseline to week 12
|
Body fat percentage assessed using a bioimpedance scale.
|
Baseline to week 12
|
|
Body mass index
Time Frame: Baseline to week 12
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Body mass index assessed using a standard kg/m2 measurement.
|
Baseline to week 12
|
|
Fasted blood glucose
Time Frame: Baseline to week 12
|
Fasted blood glucose (min 8h fast), in millimoles per litre, assessed using a prick-a-finger method and a blood glucose monitor.
|
Baseline to week 12
|
|
Sweet food and beverage preferences
Time Frame: Baseline to week 12
|
Preferences for sweet foods and beverages will be assessed using a taste perception test.
Participants will taste commercially available several sweet and non-sweet foods and beverages and indicate how pleasant these are and how much they desire to eat these using 0-100 visual analogue scales.
Higher scores indicate greater pleasantness and desire to eat.
|
Baseline to week 12
|
|
Sweet food and beverage perceptions
Time Frame: Baseline to week 12
|
Preferences of the sweet taste intensity will be assessed using a taste perception test.
Participants will taste several commercially available sweet and non-sweet foods and beverages and indicate their sweetness intensity using 0-100 visual analogue scales.
Higher scores indicate greater perceived sweetness intensity.
|
Baseline to week 12
|
|
Sweet food and beverage choice
Time Frame: Baseline to week 12
|
Sweet food and beverage choice will be assessed using a breakfast meal.
A wide selection of commercially available sweet and non-sweet breakfast foods and beverages will be presented, with participants free to choose what and how much they consume.
Sweet food and beverage choices will be measured as the weight consumed during the breakfast meal.
A take-home beverage will also be offered from a selection of sweet and non-sweet beverages with the choice recorded.
|
Baseline to week 12
|
|
Adverse events
Time Frame: Baseline to week 12
|
Adverse events will be assessed via self-report.
|
Baseline to week 12
|
|
Dietary advice evaluation
Time Frame: week 3 to week 12
|
Evaluation of and perceptions of the dietary advice received will be assessed by self-report using individual questions using online surveys.
|
week 3 to week 12
|
|
Sweet attitudes
Time Frame: Baseline to week 12
|
Attitudes toward sugars, sweeteners, and sweet foods will be assessed using the Sweet Talk Questionnaire in six domains.
The higher the score in a given domain, the more prevalent the attitude.
|
Baseline to week 12
|
|
Self-reported quality of life
Time Frame: Baseline to week 12
|
Physical and psychosocial functioning will be assessed using the 36-item Short Form Health Survey.
Higher scores indicate greater quality of life.
|
Baseline to week 12
|
|
Attitudes towards eating
Time Frame: Baseline to week 12
|
General attitudes towards eating will be assessed using the Dutch Eating Behaviour Questionnaire in three domains.
The higher the score in a given domain, the more prevalent the behaviour.
|
Baseline to week 12
|
|
Dietary knowledge
Time Frame: Baseline to week 12
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Knowledge of dietary and sugar recommendations will be assessed via self-report using specific indvidual questions in an online questionnaire.
|
Baseline to week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
April 11, 2025
First Posted (Actual)
April 13, 2025
Study Record Updates
Last Update Posted (Actual)
June 12, 2025
Last Update Submitted That Met QC Criteria
June 9, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BielatRCT2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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