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| Name | Class |
|---|---|
| University of Bristol | OTHER |
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This study will assess the impact of repeated sweet breakfast consumption versus repeated non-sweet breakfast consumption on subsequent sweet and non-sweet food preferences and intakes
Participants will be randomized to receive either sweet or non-sweet breakfasts for three consecutive weeks, and impacts on food preferences and intakes will be assessed at baseline (day 0), after 1 week (day 7), and after three weeks (day 21). Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch. Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum. Intervention breakfasts will only be consumed on the days between test days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sweet food consumption | Experimental | Sweet breakfasts. Participants are asked to consume a sweet breakfast every day for three weeks (excepting on three days when outcomes will be assessed (days 0, 7 and 21, day 21 reported). All foods will be provided. |
|
| Non-sweet food consumption | Active Comparator | Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day for three weeks (excepting on three days when outcomes will be assessed (days 0, 7 and 21, day 21 reported). All foods will be provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sweet food consumption | Behavioral | Sweet food consumption at breakfast |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Food Preferences | Ratings of three sweet and three non-sweet foods during a taste test at breakfast. Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat). Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor. Assessments made on Day 0, 7 and 21, Day 21 reported. | 3 weeks from baseline |
| Food Intake | Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported) | 3 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger Ratings | Ratings of subjective perceptions (two meals). Ratings measured using 100mm VAS scales for different subjective factors - hunger, thirst, fullness. Scores range from 0-100 where 0=least and 100=greatest for each subjective factor. Assessments made on Day 0, 7 and 21, Day 21 reported. | 3 weeks from baseline |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Appleton, PhD | Bournemouth University, UK | Principal Investigator |
| Peter Rogers, PhD | University of Bristol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bournemouth University | Bournemouth | US and Canada Only | BH12 5BB | United Kingdom |
The full study protocol is currently available from the PI on reasonable request. All generated data will be available from the PI, following completion and publication of the work on reasonable request.
Data will be available following completion and publication of the study. Data will be stored for ten years following publication of the work.
Direct contact and reasonable request of the PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sweet Food Consumption | Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast |
| FG001 | Non-sweet Food Consumption | Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sweet Food Consumption | Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast |
| BG001 | Non-sweet Food Consumption |
| 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 | Food Preferences | Ratings of three sweet and three non-sweet foods during a taste test at breakfast. Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat). Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor. Assessments made on Day 0, 7 and 21, Day 21 reported. | Intention-to-Treat | Posted | Mean | Standard Error | units on a scale | 3 weeks from baseline |
|
3 weeks
verbal 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 | Sweet Food Consumption | Sweet breakfasts. Participants are asked to consume a sweet breakfast every day. All foods will be provided. Sweet food consumption: Sweet food consumption at breakfast |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 | Jul 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Intervention allocation will be undertaken by a researcher not directly involved with participants following randomization by drawing lots.
| Non-sweet food consumption |
| Behavioral |
Non-sweet food consumption at breakfast |
|
| Food Preferences at Lunch |
Ratings of three sweet and three non-sweet foods during a taste test at lunch. Measures are the same as those used at breakfast. Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat). Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor. Assessments made on Day 0, 7 and 21, Day 21 reported. |
| 3 weeks from baseline |
| Food Intake at Lunch | Amount of sweet and non-sweet foods consumed during lunch on test days (days 0, 7 and 21, day 21 reported). | 3 weeks from baseline |
Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided.
Non-sweet food consumption: Non-sweet food consumption at breakfast
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided.
Non-sweet food consumption: Non-sweet food consumption at breakfast
|
|
| Primary | Food Intake | Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported) | Intention-to-Treat | Posted | Mean | Standard Error | percentage of total food consumed | 3 weeks from baseline |
|
|
|
| Secondary | Hunger Ratings | Ratings of subjective perceptions (two meals). Ratings measured using 100mm VAS scales for different subjective factors - hunger, thirst, fullness. Scores range from 0-100 where 0=least and 100=greatest for each subjective factor. Assessments made on Day 0, 7 and 21, Day 21 reported. | Intention-to-Treat | Posted | Mean | Standard Deviation | units on a scale | 3 weeks from baseline |
|
|
|
| Secondary | Food Preferences at Lunch | Ratings of three sweet and three non-sweet foods during a taste test at lunch. Measures are the same as those used at breakfast. Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat). Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor. Assessments made on Day 0, 7 and 21, Day 21 reported. | Intention-to-Treat | Posted | Mean | Standard Deviation | units on a scale | 3 weeks from baseline |
|
|
|
| Secondary | Food Intake at Lunch | Amount of sweet and non-sweet foods consumed during lunch on test days (days 0, 7 and 21, day 21 reported). | Intention-to-Treat | Posted | Mean | Standard Deviation | percentage of total food consumed | 3 weeks from baseline |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Non-sweet Food Consumption | Non-sweet breakfasts. Participants are asked to consume a non-sweet breakfast every day. All foods will be provided. Non-sweet food consumption: Non-sweet food consumption at breakfast | 0 | 27 | 0 | 27 | 0 | 27 |
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| Thirst |
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