Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment

Study Overview
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Brief Summary
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The proposed project will examine the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB).

Detailed Description
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The proposed project addresses critical gaps in the understanding of the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB). Half of Americans consume SSBs on any given day. Regular SSB intake is considered a contributing factor to excess energy intake, weight gain, and obesity, which impacts 70% of Americans. A contributing factor to repeated SSB consumption is sugar intake causes the release of dopamine (DA) and opioids in the striatum, providing positive reinforcement. As such, multiple brain-based models of food reward-driven obesity have been proposed, largely focusing on the striatum and executive functioning. These brain-based models of obesity have elucidated risk factors for overconsumption of high-sugar foods; however, data supporting these competing models rely heavily on observational studies in small samples. Importantly, previous reports from the investigators lab and others directly implicate eating behavior patterns as a vital contributor to aberrant neurobehavioral responses to food stimuli. However, without experimental evidence, there are fundamental gaps in the investigators knowledge about the neurobehavioral adaptations that occur as an individual begins to regularly consume a SSB prior to weight change. As observational data suggest, it is also crucial to examine individual difference factors that may exacerbate or protect against adaptations associated with regular SSB intake, as well as whether these adaptions are specific.

Official Title
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Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment

Conditions
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Obesity, Weight Gain

Intervention / Treatment
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* Dietary Supplement: Black Cherry and Orange Flavored Beverage with added sugar
* Dietary Supplement: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar
* Dietary Supplement: Black Cherry and Orange Flavored Beverage no added sugar
* Dietary Supplement: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar
* Other: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential participants will be eligible for the study if they have BMI scores between the 18 and 34 at baseline. Exclusion Criteria: Individuals with probable current Axis I psychopathology or any fMRI contra-indicators (e.g., metal implants, braces) will be excluded. Those with a probable Axis I diagnosis will be provided with treatment referral information and encouraged to seek treatment, current regular use (3 or more times a week) of psychoactive drugs (e.g., cocaine, marijuana, nicotine), regular smoking, serious medical problems (e.g., cancer, diabetes), dietary practices that do not allow intake of intervention beverages.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stratified randomization techniques will be used to distribute: 1) male & females, 2) those with a BMI > 26.1 & those with a BMI < 26.1, and 3) regular SSB consumers (> 1/day; 12 fl oz) & low or non-SSB consumers equally across the 2 experimental conditions (SSB vs. unsweetened beverage) and then to the two flavors within each experimental condition. BMI of 26.0 was selected as it is the midpoint of inclusion criteria 18 < BMI < 34.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beverage A (Sweetened)<br>One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. | Dietary Supplement: Black Cherry and Orange Flavored Beverage with added sugar<br>* 10 oz daily for three weeks<br>* Other names: Kool-Aid®;Other: Water<br>* Three mL administered per associated logo presentation only during MRI procedure.<br>|
| Active Comparator: Beverage B (Sweetened)<br>One quarter of the group to receive strawberry kiwi & lemonade flavored beverage with added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. | Dietary Supplement: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar<br>* 10 oz daily for three weeks<br>* Other names: Kool-Aid®;Other: Water<br>* Three mL administered per associated logo presentation only during MRI procedure.<br>|
| Active Comparator: Beverage A (Unsweetened)<br>One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. | Dietary Supplement: Black Cherry and Orange Flavored Beverage no added sugar<br>* 10 oz daily for three weeks<br>* Other names: Kool-Aid®;Other: Water<br>* Three mL administered per associated logo presentation only during MRI procedure.<br>|
| Active Comparator: Beverage B (Unsweetened)<br>One quarter of the group to receive strawberry kiwi & lemonade flavored beverage no added sugar for 3 weeks. MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI. | Dietary Supplement: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar<br>* 10 oz daily for three weeks<br>* Other names: Kool-Aid®;Other: Water<br>* Three mL administered per associated logo presentation only during MRI procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo | The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages (sweet and unsweet) and a water solution, and logo-elicited anticipation of both beverages and water solution. The visual stimuli are two beverage logos, a water logo, and a fixation cross. Each logo (1 second) signals impending delivery of 3 mL of the associated juice/water over 6 seconds, with the fixation cross otherwise presented. A jitter ranging from 5 to 13 seconds follows each trial. In total, the participants are shown 24 repeats of the events of interest over 4, 7-minute runs. Contrasts of interest are the post- > pre-intervention BOLD response to sweetened beverage logo > water logo. Parameter estimates for these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in whole-brain BOLD response for sweetened beverage logo > water logo for each arm. | Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI) | The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages, (sweetened and unsweetened) and a water solution, and logo-elicited anticipation of both beverages and water solution. Whole-brain analyses are performed. Contrasts of interest for the within-subject models are post-intervention > pre-intervention BOLD response to beverage vs. water logo and contrasts of interest for the group model are sweetened beverage logo > water logo. To test the interaction of brain activation with BMI, BMI is entered as a covariate in the group model. Parameter estimates of significant BOLD response to these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in BOLD response in the putamen for the sweetened beverage logo > water logo for each arm. | Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment | 
| Beverage Perceptual Ratings Using Visual Analog Scales | Perceptual ratings of the assigned beverage using visual analog scales are assessed at the pre- and post-intervention behavioral visits. Visual analog scales (VAS) are presented on an iPad screen. The scale assesses response to taste after the participant consumes a small amount of the beverage. Perceived pleasantness of, and desire to consume the two beverages is measured using adapted labeled hedonic scales at pre-/post-intervention. Pleasantness is phrased 'How pleasant is this taste' and anchored by (-100) 'most unpleasant imaginable' to (100) 'most pleasant imaginable', and 'neutral' (0) in the middle. Desire follows a similar pattern using 'desire to consume' as the phrasing. Pleasantness and desire of the assigned beverage is also evaluated at the 9 intervention assessments. Higher scores represent higher pleasantness and desire. | Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment | 
| Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task | Stop-signal reaction time to assigned beverage logo are assessed at the pre- and post-intervention visits. The behavioral response inhibition task (stop-signal task) examines motor disinhibition in response to beverage logos. This allows for the assessment of bias toward the logos and is sensitive to detect changes due to the intervention. The task is performed on an iPad app where participants complete the task twice, once at the pre-intervention and once at the post-intervention behavioral visit. The task contains 6 runs, where 3 runs present the logo of the assigned beverage and the other 3 present the logo of the same-flavor unassigned beverage. Within each run of this task, 64 (20 go) trials are presented, and participants are instructed to make a speeded response to a go stimulus except for trials when a stop signal occurs (an X presented over the logo), in which case participants are instructed to withhold their response. | Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, obesity, weight gain, sugar, sugar sweetened beverage, dopamine, neurobehavioral adaptation