Dietary BehaviourNCT05672017
Sweet Consumption and Subsequent Sweet Food Preferences and Intakes
A study testing Dietary Instructions in people with Dietary Behaviour, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
This study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Behaviour
- What is being tested?
- Dietary Instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 31 Dec 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;
- habitually consume breakfast;
- able to provide consent and complete all study materials;
- able to attend Bournemouth University for testing.
Who cannot join
- 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 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.
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 study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.
Read the detailed description
Participants will be randomized to receive instructions to either increase, decrease or make no change to sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during a taste test at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at a subsequent breakfast at the assessment time. Buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast will be provided ad-libitum.
A subset of participants (selected at random) (10 participants randomized to increase sweet food consumption and 10 participants randomized to decrease sweet food consumption) will also be assessed via MRI and fMRI scanning to investigate brain structure and functional connectivity.
- Conditions
- Dietary Behaviour
- Being tested
- Dietary Instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InstructionsBehavioural
Dietary Instructions
| Study group | Role | What they receive |
|---|---|---|
| Dietary Instructions: Increase sweet food consumption | Active comparator | Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and additional means of increasing sweet food consumption will be offered. Receives: Behavioral: Dietary Instructions |
| Dietary Instructions: Decrease sweet food consumption | Active comparator | Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and means of decreasing sweet food consumption will be offered. Receives: Behavioral: Dietary Instructions |
| Dietary Instructions: Usual Diet | Placebo comparator | Participants are asked to retain their consumption of sweet foods throughout their diet. Receives: Behavioral: Dietary Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, from 0 to 100mm. Higher scores signify stronger preferences
Measured: Week 1
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 as a percentage of weight consumed
Measured: Week 1
Secondary outcomes (4)
Hunger and Thirst
Ratings of subjective perceptions, assessed using 100mm VAS from 0 (lower hunger) to 100 (higher hunger) mm
Measured: Week 1
Sweet Food Perceptions
Perceptions for various sweet foods/fluids, assessed using a taste test, where participants sample several sweet and non-sweet foods and rate them for intensity on a 100mm Visual Analogue Scale from 0 to 100mm. Higher scores signify stronger perceptions
Measured: Week 1
MRI Static Brain Scan (Subset of Participants Only)
Static brain scan gained from a 3-Tesla Siemens Magnetom Lumina scanner (Siemens Healthcare, Erlangen, Germany), used to investigate brain structure, where the anatomical structure (e.g. size, shape) of the brain, measured via surface area (mm squared), will be compared at baseline and week 1
Measured: Baseline to week 1
fMRI Composite Functional Brain Scan (Subset of Participants Only)
Composite fMRI functional scan to investigate brain functionality and connectivity in response to a 10 min cognitive task, will be gained from a 3-Tesla Siemens Magnetom Lumina scanner (Siemens Healthcare, Erlangen, Germany), where patterns of activity will be measured using blood oxygenation level-dependent (BOLD) contrast whole-brain functional images, acquired using a T2-weighted gradient-echo Echo Planar Imaging (EPI) sequence and a 32-channel head coil during a 10 min cognitive task, and will be compared at baseline and week 1 (for full details of this methodology see Yankouskaya A, et al., Biology, 2023, 12, 211.)
Measured: Baseline to week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Mar 2023
- Primary completion31 Mar 2024
- Study completion31 Dec 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary BehaviourStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine M Appleton, Principal investigator, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672017
- Sponsor's protocol ID
- AppletonRSFC2022
- Status last verified
- Jun 2025
- First submitted
- 3 Jan 2023
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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
Publications
This project is associated with Clinical Trails Registration: NCT03427658
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweet Consumption and Subsequent Sweet Food Preferences and Intakes
- ClinicalTrials.gov ID
- NCT05672017
- Acronym / sponsor ID
- AppletonRSFC2022
- Conditions
- Dietary Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Posted 26 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 study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.
Detailed description
Participants will be randomized to receive instructions to either increase, decrease or make no change to sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during a taste test at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at a subsequent breakfast at the assessment time. Buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast will be provided ad-libitum.
A subset of participants (selected at random) (10 participants randomized to increase sweet food consumption and 10 participants randomized to decrease sweet food consumption) will also be assessed via MRI and fMRI scanning to investigate brain structure and functional connectivity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Instructions: Increase sweet food consumption | Active comparator | Behavioral: Dietary InstructionsParticipants are asked to increase their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and additional means of increasing sweet food consumption will be offered. |
| Dietary Instructions: Decrease sweet food consumption | Active comparator | Behavioral: Dietary InstructionsParticipants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be provided with clear instructions, where sweet foods will be highlighted and means of decreasing sweet food consumption will be offered. |
| Dietary Instructions: Usual Diet | Placebo comparator | Behavioral: Dietary InstructionsParticipants are asked to retain their consumption of sweet foods throughout their diet. |
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;
- habitually consume breakfast;
- able to provide consent and complete all study materials;
- able to attend Bournemouth University for testing.
Key exclusion criteria (6 listed)
- 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 or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
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 InstructionsDietary Instructions | Behavioural | Dietary Instructions: Decrease sweet food consumption, Dietary Instructions: Increase sweet food consumption, Dietary Instructions: Usual Diet |
Primary outcome
Sweet Food Preferences
Time frame: Week 1
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, from 0 to 100mm. Higher scores signify stronger preferences
Sweet Food Choices
Time frame: Week 1
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 as a percentage of weight consumed
4 secondary outcomes
Hunger and Thirst
Time frame: Week 1
Sweet Food Perceptions
Time frame: Week 1
MRI Static Brain Scan (Subset of Participants Only)
Time frame: Baseline to week 1
fMRI Composite Functional Brain Scan (Subset of Participants Only)
Time frame: Baseline to week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundThis project is associated with Clinical Trails Registration: NCT03427658
- 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 M 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 Instructions in people with Dietary Behaviour, 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 26 Jun 2025. 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 26 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?
Sweet Food Preferences (time frame: Week 1). 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?
On the ClinicalTrials.gov record for NCT05672017, which also lists 1 linked publication.
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 26 Jun 2025.