Dietary RecommendationsNCT04816955
Dietary Recommendations for Reducing Free Sugar Intakes
A study testing Dietary recommendations in people with Dietary Recommendations, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Recommendations
- What is being tested?
- Dietary recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-65 years;
- able to provide consent and complete all study materials;
- consuming >5% of TEI from free sugars; and
- residing in the South of England.
Who cannot join
- individuals who are pregnant or breastfeeding;
- underweight (BMI <18.5);
- have pre-existing medical conditions affecting swallow ability, taste and smell perception;
- currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
- current smokers or have smoked within 3 months of the study start date;
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bournemouth University
Bournemouth, US and Canada Only, BH12 5BB
About this study
This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population.
Read the detailed description
The primary objective of this randomised control trial is to assess the impacts of Public Health England's (PHE) current free sugar reducing advice, for reducing total energy intakes (TEI) of free sugar. A total of 240 participants (age 18-65years) consuming diets >5% total energy intake from dietary free sugars will be recruited from across the Dorset region. Participants to be randomly assigned into the following recommendation interventions groups: 1) Reduce free sugar intake to <5% TEI (nutrient-based recommendations); 2) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars (nutrient- + food-based recommendations); 3) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars and replace/swap with low sugar versions (nutrient- + food-based recommendations with swaps); and 4) Control Group. 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.
- Conditions
- Dietary Recommendations
- Being tested
- Dietary recommendations
- Keywords
- free sugars, dietary intake, dietary recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary recommendationsBehavioural
Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
| Study group | Role | What they receive |
|---|---|---|
| Nutrient-based recommendations | Experimental | Participants in this group will be given nutrient-based recommendations to reduce free sugar intakes. Receives: Behavioral: Dietary recommendations |
| Nutrient- and food-based recommendations | Experimental | Participants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes. Receives: Behavioral: Dietary recommendations |
| Nutrient- and food-based recommendations with food swaps | Experimental | Participants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. Receives: Behavioral: Dietary recommendations |
| Control | Placebo comparator | Participants in this group will not be given any recommendations to reduce free sugar intakes. Receives: Behavioral: Dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free Sugar Intakes
Percentage energy intake from free sugars, assessed using diet diaries
Measured: 12 weeks from baseline
Number of Participants Who Adhered to the Recommendations Provided
Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence
Measured: 12 weeks from baseline
Secondary outcomes (9)
Dietary Intakes
Energy intake, assessed using diet diaries
Measured: 12 weeks from baseline
BMI
Body Mass Index, assessed using researcher measurements or researcher-observed self-measurements
Measured: 12 weeks from baseline
Sweet Food Preferences
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, scored from 0-100mm. Higher scores signify stronger preferences
Measured: 12 weeks from baseline
Sweet Food Choices
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
Measured: 12 weeks from baseline
Sweet Food Attitudes
Attitudes towards sugar, sweeteners, and sweet-tasting foods, assessed using the SSS questionnaire (Tang et al., 2024, Appetite, 2024, 194, 107169. DOI: 10.1016/j.appet.2023.107169). Scales scored between 0 and 5. Higher scores denote stronger attitudes.
Measured: 12 weeks from baseline
Number of Participants Reporting Adverse Events
Adverse events, assessed by self-report, measured in terms of number of participants rather than number of events
Measured: Baseline to 12 weeks
Eating-based Attitudes
Attitudes towards eating, assessed using the Three Factor Eating Questionnaire (Karlsson J, et al. IJO 2000; 24: 1715-1725)
Measured: Baseline to 12 weeks
Eating-based Motivations
Motivations towards eating, assessed using the Food Choice Questionnaire (Steptoe et al., Appetite 1995, 25(3): 267-84), with values raning from 1-5. Higher scores denote stronger motivations
Measured: Baseline to 12 weeks
Quality of Life (Subjective Wellbeing)
Quality of Life, measured using the Short Form - 36 questionnaire (Ware et al, 1996), where Quality of Life is assessed out of 100, scored from 0-100, where a higher score demonstrates better quality of life
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 May 2021
- Primary completion20 Dec 2022
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dietary RecommendationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Appleton, Principal investigator, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816955
- Sponsor's protocol ID
- PhDBoxall
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2021
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised study data will be available on completion of the trial from the PI
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Recommendations for Reducing Free Sugar Intakes
- ClinicalTrials.gov ID
- NCT04816955
- Acronym / sponsor ID
- PhDBoxall
- Conditions
- Dietary Recommendations
- Keywords
- free sugars, dietary intake, dietary recommendations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population.
Detailed description
The primary objective of this randomised control trial is to assess the impacts of Public Health England's (PHE) current free sugar reducing advice, for reducing total energy intakes (TEI) of free sugar. A total of 240 participants (age 18-65years) consuming diets >5% total energy intake from dietary free sugars will be recruited from across the Dorset region. Participants to be randomly assigned into the following recommendation interventions groups: 1) Reduce free sugar intake to <5% TEI (nutrient-based recommendations); 2) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars (nutrient- + food-based recommendations); 3) Reduce free sugar intake to <5% TEI, via reducing intake of specific foods identified as high in free sugars and replace/swap with low sugar versions (nutrient- + food-based recommendations with swaps); and 4) Control Group. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nutrient-based recommendations | Experimental | Behavioral: Dietary recommendationsParticipants in this group will be given nutrient-based recommendations to reduce free sugar intakes. |
| Nutrient- and food-based recommendations | Experimental | Behavioral: Dietary recommendationsParticipants in this group will be given nutrient- and food-based recommendations to reduce free sugar intakes. |
| Nutrient- and food-based recommendations with food swaps | Experimental | Behavioral: Dietary recommendationsParticipants in this group will be given nutrient- and food-based recommendations and advice on food swaps to reduce free sugar intakes. |
| Control | Placebo comparator | Behavioral: Dietary recommendationsParticipants in this group will not be given any recommendations to reduce free sugar intakes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18-65 years;
- able to provide consent and complete all study materials;
- consuming >5% of TEI from free sugars; and
- residing in the South of England.
Key exclusion criteria (6 listed)
- individuals who are pregnant or breastfeeding;
- underweight (BMI <18.5);
- have pre-existing medical conditions affecting swallow ability, taste and smell perception;
- currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
- current smokers or have smoked within 3 months of the study start date;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary recommendationsDietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations | Behavioural | Control, Nutrient- and food-based recommendations, Nutrient- and food-based recommendations with food swaps, Nutrient-based recommendations |
Primary outcome
Free Sugar Intakes
Time frame: 12 weeks from baseline
Percentage energy intake from free sugars, assessed using diet diaries
Number of Participants Who Adhered to the Recommendations Provided
Time frame: 12 weeks from baseline
Adherence to the recommendations provided, assessed using diet diaries and self-reported adherence
9 secondary outcomes
Dietary Intakes
Time frame: 12 weeks from baseline
BMI
Time frame: 12 weeks from baseline
Sweet Food Preferences
Time frame: 12 weeks from baseline
Sweet Food Choices
Time frame: 12 weeks from baseline
Sweet Food Attitudes
Time frame: 12 weeks from baseline
Number of Participants Reporting Adverse Events
Time frame: Baseline to 12 weeks
Eating-based Attitudes
Time frame: Baseline to 12 weeks
Eating-based Motivations
Time frame: Baseline to 12 weeks
Quality of Life (Subjective Wellbeing)
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymised study data will be available on completion of the trial from the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Appleton principal investigator
Bournemouth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary recommendations in people with Dietary Recommendations, run by Bournemouth University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free Sugar Intakes (time frame: 12 weeks from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.