Clinical trial NCT03490734: Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
Official title: Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Gain
Keywords: nutrition
obesity
weight gain
sugar
sugar sweetened beverage
dopamine
neurobehavioral adaptation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-04-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
Secondary outcomes:
measure: Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI)
timeFrame: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Beverage Perceptual Ratings Using Visual Analog Scales
timeFrame: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment
measure: Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task
timeFrame: Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment
Other outcomes:
measure: Percent Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in During Rest
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Modulation of Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo by TaqIA Single Nucleotide Polymorphism Status
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Food Pattern From Baseline to Post-Intervention Assessment by Food Frequency Questionnaire
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Beverage Intake Pattern From Baseline to Post-Intervention Assessment by Beverage Intake Questionnaire
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Physical Activity From Baseline to Post-Intervention Assessment by the Short-Form International Physical Activity Questionnaire
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Restrained Eating Subscale Score as Measured on Dutch Eating Behavior Questionnaire
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Food Craving as Assessed by the Food Craving Inventory (FCI) Score Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Hedonic Hunger as Assessed by the Power of Food Scale (PFS) Score
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Food Habits as Assessed by the Yale Food Addiction Scale
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in General Impulsivity as Assessed by the Barrett Impulsiveness Scale
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in General Sensitivity to Reward and Sensitivity to Punishment as Assessed by the Sensitivity to Punishment and Sensitivity to Reward Questionnaire
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
measure: Change in Behavioral Approach and Behavioral Inhibition as Assessed by the BIS/BAS Scales
timeFrame: Baseline Assessment; Post-Intervention Assessment, Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment
Locations:
city: Chapel Hill
country: United States
facility: Mcgavran-Greenberg Hall
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kyle Burger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peirce JW. PsychoPy--Psychophysics software in Python. J Neurosci Methods. 2007 May 15;162(1-2):8-13. doi: 10.1016/j.jneumeth.2006.11.017. Epub 2007 Jan 23.