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| Name | Class |
|---|---|
| University of Bristol | OTHER |
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This study will assess the impact 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 or decrease 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Increase sweet food consumption | Experimental | Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended. |
|
| Decrease sweet food consumption | Active Comparator | Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sweet food consumption | Behavioral | Comparison of the impacts of sweet and non-sweet food consumption |
|
| Measure | Description | Time Frame |
|---|---|---|
| Food Preferences | Ratings of three sweet and three non-sweet foods during a taste test (two tests). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher preferences. | Change from Baseline to 1 week |
| Food Intake | Amount of sweet and non-sweet foods consumed during breakfast and lunch. Measures are made of grams of each sweet food consumed. | Change from Baseline to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger Ratings | Ratings of subjective perceptions (two meals). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher hunger. | Change from Baseline to 1 week |
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Inclusion Criteria:
Race / ethnicity will not be requested.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rogers, PhD | University of Bristol | Principal Investigator |
| Katherine Appleton, PhD | Bournemouth University, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bristol | Bristol | BS8 1TN | 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 | Increase Sweet Food Consumption | Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended. Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption |
| FG001 | Decrease Sweet Food Consumption | Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended. Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Increase Sweet Food Consumption | Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended. Sweet food consumption: Comparison of the impacts of sweet and 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 (two tests). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher preferences. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to 1 week |
|
1 week
All participants are asked if they experienced any difficulties. Adverse events are disclosed voluntarily and spontaneously by participants.
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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 | Increase Sweet Food Consumption | Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended. Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Katherine Appleton | Bournemouth University | +441202965985 | 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 | May 3, 2024 | May 3, 2024 | 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 in direct contact with any one participant, following randomization by drawing lots.
| BG001 | Decrease Sweet Food Consumption | Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended. Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption |
| BG002 | 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 supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended.
Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption
|
|
| Primary | Food Intake | Amount of sweet and non-sweet foods consumed during breakfast and lunch. Measures are made of grams of each sweet food consumed. | Posted | Mean | Standard Deviation | grams sweet food | Change from Baseline to 1 week |
|
|
|
| Secondary | Hunger Ratings | Ratings of subjective perceptions (two meals). Measures are made on a visual analogue scale from 0 (not at all) to 100 (extremely), where higher scores denote higher hunger. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline to 1 week |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Decrease Sweet Food Consumption | Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended. Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption | 0 | 15 | 0 | 15 | 0 | 15 |
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