- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684757
Reducing Free Sugar Intakes: A Role for Sweet Taste
May 2, 2023 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
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this randomised control trial is to assess the effects of three different types of dietary advice, for reducing total energy intakes (TEI) of free sugar.
A total of 150 participants (age 18-65years) 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 randomized to replace high sugar foods with: 1) foods that are low in sugars, but high in sweet taste; 2) foods 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 12. Secondary outcomes include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetener intakes and adherence levels at week 12.
Study Type
Interventional
Enrollment (Anticipated)
150
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 Contact
- Name: Katherine M Appleton
- Phone Number: 01202965985
- Email: k.appleton@bournemouth.ac.uk
Study Locations
-
-
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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
- 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.
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: Dietary Advice: Sweet Taste
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.
|
Dietary Advice
|
Active Comparator: Dietary Advice: Taste
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.
|
Dietary Advice
|
Active Comparator: Dietary Advice: No taste
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.
|
Dietary Advice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Free sugar intakes
Time Frame: Baseline to week 12
|
Percentage energy intake from free sugars, assessed using diet diaries
|
Baseline to week 12
|
Adherence
Time Frame: Baseline to week 12
|
Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence
|
Baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary Intakes
Time Frame: Baseline to week 12
|
Nutrient composition and taste of dietary intakes, assessed using diet diaries
|
Baseline to week 12
|
Body weight
Time Frame: Baseline to week 12
|
Body weight, in kg, assessed using researcher measurements
|
Baseline to week 12
|
BMI
Time Frame: Baseline to week 12
|
BMI, in kg/m2, assessed using researcher measurements
|
Baseline to week 12
|
Waist circumference
Time Frame: Baseline to week 12
|
Waist circumference, in cm, assessed using researcher measurements
|
Baseline to week 12
|
Body fat percentage
Time Frame: Baseline to week 12
|
Body fat percentage, assessed using bioimpedence, as conducted by the researcher measurements
|
Baseline to week 12
|
Sweet food preferences
Time Frame: Baseline to week 12
|
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 12
|
Sweet food perceptions
Time Frame: Baseline to week 12
|
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 12
|
Sweet food intakes
Time Frame: Baseline to week 12
|
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 12
|
Sweet food attitudes
Time Frame: Baseline to week 12
|
Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using a questionnaire, soon to be published.
Higher scores denote stronger attitudes.
|
Baseline to week 12
|
Adverse events
Time Frame: Baseline to week 12
|
Adverse events, assessed by self-report
|
Baseline to week 12
|
Eating-based attitudes
Time Frame: Baseline to week 12
|
Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al.
IJO 2000; 24: 1715-1725)
|
Baseline to week 12
|
Subjective Quality of Life
Time Frame: Baseline to week 12
|
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 12
|
Barriers and facilitators to success
Time Frame: Week 12
|
An assessment of barriers and facilitators to success, assessed by self-report questionnaire
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Katherine M Appleton, Bournemouth University
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)
March 1, 2023
Primary Completion (Anticipated)
December 20, 2023
Study Completion (Anticipated)
September 30, 2024
Study Registration Dates
First Submitted
January 3, 2023
First Submitted That Met QC Criteria
January 12, 2023
First Posted (Actual)
January 13, 2023
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- AppletonRFS2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymised study data will be available on completion of the trial from the PI
IPD Sharing Time Frame
On study completion
IPD Sharing Access Criteria
Reasonable request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.
Clinical Trials on Dietary Behaviour
-
Bournemouth UniversityEnrolling by invitation
-
Bournemouth UniversityEnrolling by invitationDietary BehaviourUnited Kingdom
-
Western University, CanadaNot yet recruitingSedentary Behaviour | Health Behaviour ChangeCanada
-
University of OxfordClasado Biosciences LtdUnknown
-
Claude Bernard UniversityCompleted
-
University of NottinghamUnilever R&DCompletedBehaviourUnited Kingdom
-
Jimma UniversityWorld Bank; Ethiopian Public Health InstituteCompleted
-
University of BirminghamEconomic and Social Research Council, United Kingdom; C H & Co Ltd.CompletedEating BehaviourUnited Kingdom
-
University Children's Hospital, ZurichCompletedPostoperative BehaviourSwitzerland
Clinical Trials on Dietary Advice
-
VU University of AmsterdamAmsterdam UMC, location VUmc; University of HelsinkiCompletedPhysical Disability | Protein-Energy MalnutritionFinland, Netherlands
-
University of Auckland, New ZealandEnrolling by invitation
-
Endocrinology and Clinical Nutrition Research Center...UnknownFrail Elderly Syndrome | SarcopeniaSpain
-
Universiti Teknologi MaraInternational Medical UniversityCompletedObesity | Type 2 Diabetes Mellitus | Diabetic Kidney DiseaseMalaysia
-
King's College LondonProcter and GambleCompleted
-
Bournemouth UniversityEnrolling by invitation
-
Federal University of Health Science of Porto AlegreConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedAnemia | Overweight and Obesity | Breast Feeding, ExclusiveBrazil
-
Federal University of Health Science of Porto AlegreCompletedPregnancy Complications | Weight GainBrazil
-
TNOVitas; SwissAnalysisCompletedDiabetes Mellitus, Type 2Netherlands