Dietary Behaviour
Conditions
Brief 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.
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.
Interventions
BEHAVIORALDietary Instructions
Dietary Instructions
Sponsors
Bournemouth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators, outcome assessors and analysts will be masked. It is not possible to mask participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. aged 18-65 years; 2. habitually consume breakfast; 3. able to provide consent and complete all study materials; 4. able to attend Bournemouth University for testing.
Exclusion criteria
1. individuals who are pregnant or breastfeeding; 2. underweight (BMI \<18.5); 3. 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; 4. have pre-existing medical conditions affecting swallow ability, taste and smell perception; 5. currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World); 6. current smokers or have smoked within 3 months of the study start date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sweet Food Preferences | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hunger and Thirst | Week 1 | Ratings of subjective perceptions, assessed using 100mm VAS from 0 (lower hunger) to 100 (higher hunger) mm |
| Sweet Food Perceptions | Week 1 | 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 |
| MRI Static Brain Scan (Subset of Participants Only) | Baseline to week 1 | 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 |
| fMRI Composite Functional Brain Scan (Subset of Participants Only) | Baseline to week 1 | 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.) |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 | 43 |
| Dietary Instructions: Usual Diet Participants are asked to retain their consumption of sweet foods throughout their diet.
Dietary Instructions: Dietary Instructions | 21 |
| Total | 104 |
Baseline characteristics
| Characteristic | Dietary Instructions: Decrease Sweet Food Consumption | Dietary Instructions: Usual Diet | Total | Dietary Instructions: Increase Sweet Food Consumption |
|---|---|---|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 6.7 | 20.6 years STANDARD_DEVIATION 1.5 | 23.9 years STANDARD_DEVIATION 6 | 24.1 years STANDARD_DEVIATION 6.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 43 participants | 21 participants | 104 participants | 40 participants |
| Sex: Female, Male Female | 30 Participants | 16 Participants | 75 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 29 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 43 | 0 / 21 |
| other Total, other adverse events | 0 / 40 | 0 / 43 | 0 / 21 |
| serious Total, serious adverse events | 0 / 40 | 0 / 43 | 0 / 21 |
Outcome results
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
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Instructions: Increase Sweet Food Consumption | Sweet Food Choices | 36 percentage of weight consumed | Standard Error 4 |
| Dietary Instructions: Decrease Sweet Food Consumption | Sweet Food Choices | 25 percentage of weight consumed | Standard Error 4 |
| Dietary Instructions: Usual Diet | Sweet Food Choices | 27 percentage of weight consumed | Standard Error 4 |
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
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Instructions: Increase Sweet Food Consumption | Sweet Food Preferences | 66 score on a scale | Standard Error 3 |
| Dietary Instructions: Decrease Sweet Food Consumption | Sweet Food Preferences | 63 score on a scale | Standard Error 3 |
| Dietary Instructions: Usual Diet | Sweet Food Preferences | 68 score on a scale | Standard Error 3 |
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.)
Time frame: Baseline to week 1
Secondary
Hunger and Thirst
Ratings of subjective perceptions, assessed using 100mm VAS from 0 (lower hunger) to 100 (higher hunger) mm
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Instructions: Increase Sweet Food Consumption | Hunger and Thirst | 57 score on a scale | Standard Deviation 18 |
| Dietary Instructions: Decrease Sweet Food Consumption | Hunger and Thirst | 65 score on a scale | Standard Deviation 20 |
| Dietary Instructions: Usual Diet | Hunger and Thirst | 64 score on a scale | Standard Deviation 18 |
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
Time frame: Baseline to 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
Time frame: Week 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Instructions: Increase Sweet Food Consumption | Sweet Food Perceptions | 71 score on a scale | Standard Error 3 |
| Dietary Instructions: Decrease Sweet Food Consumption | Sweet Food Perceptions | 77 score on a scale | Standard Error 3 |
| Dietary Instructions: Usual Diet | Sweet Food Perceptions | 73 score on a scale | Standard Error 3 |