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This study seeks to determine whether artificial sweeteners in the context of diet soda may alter the brain's response to food cues and thus impact appetite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Soda | Experimental | 12oz can of Diet Coke |
|
| Soda | Active Comparator | 12oz can of Coke |
|
| Carbonated Water | Placebo Comparator | 12oz can of carbonated (unflavored) water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet soda | Behavioral | 12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Brain Response to Food Cues in the Insula | Functional magnetic resonance imaging (BOLD signals) while patients view food vs. non-food cues. The effect size z-score represents the magnitude of the activation in that area to food cues vs. non-food cues. The z-score is the estimated response magnitude in that area compared to the overall mean. Negative numbers indicate values lower than the mean and positive numbers indicate values above the mean. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive Testing (Stop Signal Reaction Time) | stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center MRI Research Facility | Boston | Massachusetts | 02215 | United States |
Data is HIPAA protected and will not be shared.
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This is a cross-over trial, and participants were assigned to receive diet soda, regular soda, and carbonated water in a random order.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diet Soda Then Regular Soda Then Carbonated Water | Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of regular soda, 7 days washout, then third visit with 12 oz can of carbonated water. |
| FG001 | Regular Soda Then Carbonated Water Then Diet Soda | Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of diet soda. |
| FG002 | Carbonated Water Then Diet Soda Then Regular Soda | Participant had first visit with 12oz can of carbonated water, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of regular soda. |
| FG003 | Regular Soda Then Diet Soda Then Carbonated Water | Participant had first visit with 12oz can of regular soda, 7 days washout, then second visit with 12 oz can of diet soda, 7 days washout, then third visit with 12 oz can of carbonated water. |
| FG004 | Diet Soda Then Carbonated Water Then Regular Soda | Participant had first visit with 12oz can of diet soda, 7 days washout, then second visit with 12 oz can of carbonated water, 7 days washout, then third visit with 12 oz can of regular soda. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diet Soda/Regular Soda/ Carbonated Water | The same subjects participated in all three conditions. |
| 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 | Changes in Brain Response to Food Cues in the Insula | Functional magnetic resonance imaging (BOLD signals) while patients view food vs. non-food cues. The effect size z-score represents the magnitude of the activation in that area to food cues vs. non-food cues. The z-score is the estimated response magnitude in that area compared to the overall mean. Negative numbers indicate values lower than the mean and positive numbers indicate values above the mean. | Posted | Mean | Standard Error | z-score | 1 hour |
|
3 weeks
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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 | Diet Soda | 12oz can of Diet Coke diet soda: 12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olivia Farr | Beth Israel Deaconess Medical Center | 6176678636 | ofarr@bidmc.harvard.edu |
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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 | Aug 2, 2019 | Jan 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003077 | Coke |
| D061545 | Carbonated Water |
| ID | Term |
|---|---|
| D003031 | Coal |
| D005579 | Fossil Fuels |
| D045424 | Complex Mixtures |
| D004736 | Energy-Generating Resources |
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| Regular soda | Behavioral | 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas) |
|
|
| Carbonated Water | Behavioral | 12oz can of carbonated water (sparking water, selzter water) unflavored |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
12oz can of Coke
Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
| OG002 | Carbonated Water | 12oz can of carbonated (unflavored) water Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored |
|
|
| Secondary | Neurocognitive Testing (Stop Signal Reaction Time) | stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control. | Posted | Mean | Standard Error | ms | 1 hour |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Soda | 12oz can of Coke Regular soda: 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas) | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Carbonated Water | 12oz can of carbonated (unflavored) water Carbonated Water: 12oz can of carbonated water (sparking water, selzter water) unflavored | 0 | 4 | 0 | 4 | 0 | 4 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004777 |
| Environment |
| D004778 | Environment and Public Health |
| D008900 | Mineral Waters |
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D002253 | Carbonated Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D060766 | Drinking Water |
| D019602 | Food and Beverages |