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This study will assess the effects of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Dietary Instructions: Usual Diet | Placebo Comparator | Participants are asked to retain their consumption of sweet foods throughout their diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Instructions | Behavioral | Dietary Instructions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger and Thirst | Ratings of subjective perceptions, assessed using 100mm VAS from 0 (lower hunger) to 100 (higher hunger) mm | 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine M Appleton | Bournemouth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bournemouth University | Bournemouth | US and Canada Only | BH12 5BB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This project is associated with Clinical Trails Registration: NCT03427658 |
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Anonymised study data will be available on completion of the trial from the PI
On study completion
On reasonable request
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietary Instructions: Increase Sweet Food Consumption | 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. Dietary Instructions: Dietary Instructions |
| FG001 | Dietary Instructions: Decrease Sweet Food Consumption | 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. Dietary Instructions: Dietary Instructions |
| FG002 | Dietary Instructions: Usual Diet | Participants are asked to retain their consumption of sweet foods throughout their diet. Dietary Instructions: Dietary Instructions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dietary Instructions: Increase Sweet Food Consumption | 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. Dietary Instructions: Dietary Instructions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | score on a scale | Week 1 |
|
1 week
self-report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietary Instructions: Increase Sweet Food Consumption | 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. Dietary Instructions: Dietary Instructions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Katherine Appleton | Bournemouth University | 01202965985 | k.appleton@bournemouth.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | May 31, 2025 | Jun 6, 2025 | Prot_ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2024 | Apr 28, 2024 | SAP_000.pdf |
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Investigators, outcome assessors and analysts will be masked. It is not possible to mask participants.
| 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 | 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.) | Baseline to week 1 |
| BG001 |
| Dietary Instructions: Decrease Sweet Food Consumption |
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. Dietary Instructions: Dietary Instructions |
| BG002 | Dietary Instructions: Usual Diet | Participants are asked to retain their consumption of sweet foods throughout their diet. Dietary Instructions: Dietary Instructions |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. Dietary Instructions: Dietary Instructions |
| OG002 | Dietary Instructions: Usual Diet | Participants are asked to retain their consumption of sweet foods throughout their diet. Dietary Instructions: Dietary Instructions |
|
|
| Primary | 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 | Posted | Mean | Standard Error | percentage of weight consumed | Week 1 |
|
|
|
| Secondary | Hunger and Thirst | Ratings of subjective perceptions, assessed using 100mm VAS from 0 (lower hunger) to 100 (higher hunger) mm | Posted | Mean | Standard Deviation | score on a scale | Week 1 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | score on a scale | Week 1 |
|
|
|
| Secondary | 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 | Not Posted | Baseline to week 1 | Participants |
| Secondary | 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.) | Not Posted | Baseline to week 1 | Participants |
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Dietary Instructions: Decrease Sweet Food Consumption | 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. Dietary Instructions: Dietary Instructions | 0 | 43 | 0 | 43 | 0 | 43 |
| EG002 | Dietary Instructions: Usual Diet | Participants are asked to retain their consumption of sweet foods throughout their diet. Dietary Instructions: Dietary Instructions | 0 | 21 | 0 | 21 | 0 | 21 |
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| Male |
|