Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

Study Overview
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Brief Summary
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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.

Official Title
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Neurological Impacts of Artificial Sweeteners in the Context of Diet Sodas

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: diet soda
* Behavioral: Regular soda
* Behavioral: Carbonated Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women who are 18-65 years old, with a BMI >30kg/m2. Exclusion Criteria: Unable or unwilling to participate in the study for any reason Metal in the body or other safety concerns which makes patient unable to have an MRI Pregnant women will be excluded to protect the fetus against potential effects of a non-medically required MRI on fetal development and difficulty of measuring accurate BMI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet Soda<br>12oz can of Diet Coke | Behavioral: diet soda<br>* 12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)<br>* Other names: Diet Pepsi;|
| Active Comparator: Soda<br>12oz can of Coke | Behavioral: Regular soda<br>* 12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)<br>* Other names: Pepsi;|
| Placebo Comparator: Carbonated Water<br>12oz can of carbonated (unflavored) water | Behavioral: Carbonated Water<br>* 12oz can of carbonated water (sparking water, selzter water) unflavored<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial sweeteners, diet soda