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

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ClinicalTrials.gov Identifier: NCT03490734
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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).

Condition or disease Intervention/treatment Phase
Obesity Weight Gain 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: Tasteless Beverage Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description: Experimental and flavor conditions will be blinded to those performing analyses.
Primary Purpose: Diagnostic
Official Title: Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Active Comparator: Beverage A (Sweetened)

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 tasteless beverage 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
10 oz daily for three weeks
Other Name: Kool-Aid®

Other: Tasteless Beverage
A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.

Active Comparator: Beverage B (Sweetened)

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 tasteless beverage 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
10 oz daily for three weeks
Other Name: Kool-Aid®

Other: Tasteless Beverage
A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.

Active Comparator: Beverage A (Unsweetened)

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 tasteless beverage 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
10 oz daily for three weeks
Other Name: Kool-Aid®

Other: Tasteless Beverage
A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.

Active Comparator: Beverage B (Unsweetened)

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 tasteless beverage 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
10 oz daily for three weeks
Other Name: Kool-Aid®

Other: Tasteless Beverage
A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.




Primary Outcome Measures :
  1. Percent 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 [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]

    The fMRI paradigm will assess evoked blood oxygen level dependent (BOLD) response to receipt of study beverages, (sweetened and unsweetened) and a tasteless solution, and logo-elicited anticipation of both beverages and tasteless solution.

    The paradigm is controlled by in-house scripts written in PsychoPy software. The visual stimuli will be two beverage logos, a tasteless logo, and a fixation cross. Each logo (1 seconds) signals impending delivery of 3 mL of the associated juice/tasteless over 6 seconds, with the fixation cross otherwise presented. Participants are visually instructed on when to swallow. A jitter ranging from 5 to 13 (x̅ =8) seconds follow each trial. In total, the participants are presented 24 repeats of the events of interest over 4, 7 min runs.



Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The investigators use resting state fMRI (rsfMRI) data to assess intrinsic functional connectivity and network analyses. Functional connectivity is commonly quantified by measuring the synchronization of low-frequency BOLD fluctuations across pairs of brain regions of interest (ROIs) via correlation coefficients (see statistical analyses). rsfMRI data is acquired in one run of 7 minutes; participants are asked to remain still with their eyes open, and to fixate on the fixation cross.

  2. 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 [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    Saliva from participants is used to extract DNA using standard salting-out and solvent precipitation methods, to yield an average of 45 µg of DNA. The TaqIA (rs1800497) assays are done using a fluorogenic 5_nuclease (Taqman, ABI) method on an ABI Prism 7000 Sequence Detection System via the allelic discrimination mode. Reactions containing 20ng of DNA are performed in 10 µl reactions with TaqMan Universal Polymerase Chain Reaction Master Mix using standard cycling conditions. Independent investigators score allele sizes; inconsistencies are reviewed and rerun when necessary. For every assay, each 96-well plate includes non-template and DNA standards of known genotype. All genotyping is performed at the UNC-CH Advanced Analytics Core

  3. 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 Body Mass Index (BMI) [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    BMI (kg/m2) is calculated by collecting height and weight. Height is measured to the nearest mm using a stadiometer. Weight is assessed to the nearest 0.1 kg using digital scales with participants wearing light clothing without shoes at each assessment.

  4. Change in Stop Signal Reaction Time to Logo as Measured in Behavioral Response Inhibition Task [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The primary objective of the behavioral response inhibition task is to examine motor disinhibition in response to the beverage logos and control logos. This allows for behavioral assessment of bias toward the logos and is sensitive to detect change to the intervention. Participants respond as quickly and accurately as possible with a keyboard press when shown the target logo, but withhold their responses during presentation of other logos. The task is performed twice, each time depicting one of the beverage logos as the 'target' logo. Each task consists of 48 trials. For each trial, a picture of the target logo (75% occurrence) or similar logos (25% occurrence) is presented for 500 ms. Stimuli is presented and reaction times, commission and omission errors are recorded using Presentation (Neurobehavioral Systems, Davis, CA).

  5. Change score in Visual Analog Scale Ratings of Beverage Perceptual Measures [ Time Frame: Baseline Assessment; Intervention Visits 1-9, 3 weeks; Post-Intervention Assessment, approx. 5 weeks post baseline ]
    All visual analog scales are presented on an iPad screen and completed one at a time. The scale is assessing response to taste after the participant consumes a small amount of the beverage. Perceived pleasantness of, and desire to consume the two juices 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 juice is also evaluated at the 9 intervention assessments. Perceived hunger is assessed via cross-modal visual analog scales, anchored by (-100) 'I am not hungry at all' to (100) 'I have never been more hungry'. The change score is calculated from the slope of ratings plotted by time.

  6. Change in Food Pattern From Baseline to Post-Intervention Assessment by Food Frequency Questionnaire [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Food Frequency Questionnaire (FFQ) is a self-reported checklist of 76 foods and beverages with a frequency response section. Subjects report generally how often each item is consumed over a two-week period of time. The six possible responses are 1= never in the last two weeks, 2= 1-3 times in the last 2 weeks, 3= 4-6 times in the last 2 weeks, 4= 7-9 times in the last two weeks, 5= 10-13 times in the last 2 weeks, 6= daily or more in the last two weeks. Response information is used to estimate daily caloric intake (number of kcal) and macronutrient content (percent calories from carbohydrate/fat/protein). Food pattern is assessed as an aggregate of these measures. Changes in food pattern will be assessed as a difference from baseline to post-intervention assessment.

  7. Change in Beverage Intake Pattern From Baseline to Post-Intervention Assessment by Beverage Intake Questionnaire [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    To better capture variation in regular beverage intake patterns, the Beverage Intake Questionnaire is administered which queries directly about intake of all types of beverages. Similar to the Food Frequency Questionnaire, subjects report generally how often each item is consumed over a two-week period of time. The possible responses are 1= never in the last two weeks, 2= 1-3 times in the last 2 weeks, 3= 4-6 times in the last 2 weeks, 4= 7-9 times in the last two weeks, 5= 10-13 times in the last 2 weeks, 6= daily or more in the last two weeks. Responses information is used to estimate daily caloric intake from beverages (number of kcal) and macronutrient content (number of calories from carbohydrate/fat/protein). Changes in beverage intake are assessed as a difference from baseline to post-intervention assessment.

  8. Change in Physical Activity From Baseline to Post-Intervention Assessment by Minnesota Leisure-Time Activity Questionnaire [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Minnesota Leisure-Time Activity Questionnaire measures leisure time activities (both free time and domestic chores). The raw scores are indexed to a key of activity and intensity codes, which are then utilized to calculate an Activity Metabolic Index (AMI). A healthy AMI have an intensity code of 6.0 while an unhealthy AMI have intensity codes of 4.0 or less. It has shown to correlate with energy expenditure (r = .73) measured via doubly-labeled water. Changes in physical activity are assessed as a difference from baseline to post-intervention assessment.

  9. Change in Restrained Eating Subscale Score as measured on Dutch Eating Behavior Questionnaire [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rate the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores range from 10 (worse outcome) to 50 (better outcome). The change is calculated as the difference between scores at Baseline and Post-Intervention Assessment.

  10. 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 [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Food Craving Inventory is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Subjects rate how often they have experienced a craving for each food on a 5-point frequency scale, where 1=never, 2=rarely (once or twice), 3=sometimes, 4= often, 5= always/almost every day. Food craving score is calculated as a total sum, and the change score is calculated from the difference between baseline to post-intervention assessment.

  11. Change in Hedonic Hunger as assessed by the Power of Food Scale (PFS) Score [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Power of Food scale assesses reported appetitive drive, food reward responsivity, sensitivity to food cues in the environment, and the frequency of food-related thoughts. The 21-item scale prompts subjects to rate how much they agree with statements about hedonic hunger on a 5-point scale, where 1=do not agree at all, 2=agree a little, 3=agree somewhat, 4=agree, and 5=strongly agree. The change in total PFS score will be calculated from the difference between baseline to post-intervention assessment.

  12. Change in Food Habits as assessed by the Yale Food Addiction Scale [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Yale Food Addiction Scale (YFAS) is designed to identify participants who exhibit signs of possible food addiction to specific foods. The 9-item questionnaire is based on substance dependence criteria in the DSM-IV-TR, as well as on scales that are used to assess behavioral addictions. Subjects rate how often they have experienced a possible food addictive behavior on a 5-point frequency scale, where 0=never, 1=once a month, 2=2-4 times per month, 3= 2-3 times per week, 4= 4+ times per week. The change in total score is calculated from the difference between baseline to post-intervention assessment

  13. Change in General Impulsivity as assessed by the Barrett Impulsiveness Scale [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Barratt Impulsiveness Scale is one of the most commonly used self-report measures of impulsivity. This instrument comprises 15 items that assess three independent sub-dimensions of impulsivity: (a) Attention; (b) Non-planning; (c) Motor. Collectively, the three sub-dimensions represent a total impulsivity score. Items are statements about behavior and participants rate each item are scored from 1 (Rarely/Never) to 4 (Almost Always/Always). The change in total score is calculated from the difference between baseline to post-intervention assessment.

  14. Change in General Sensitivity to Reward and Sensitivity to Punishment as assessed by the Sensitivity to Punishment and Sensitivity to Reward Questionnaire. [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The Sensitivity to Punishment/Sensitivity to Reward Questionnaire (SPSRQ) is a self-reported instrument that includes 48 yes/no questions divided into two subscales: Sensitivity to Reward (SR) and Sensitivity to Punishment (SP). Items statements about behavior, and participants will rate each item are scored from 1 (Definitely True) to 5 (Definitely False). The change in total score is calculated from the difference between baseline to post-intervention assessment.

  15. Change in Behavioral Approach and Behavioral Inhibition as assessed by the BIS/BAS Scales [ Time Frame: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks post ]
    The BIS/BAS scales are designed to assess individual differences in the sensitivity of two systems: A behavioral avoidance (or inhibition) system (BIS) and a behavioral approach system (BAS). The questionnaire includes 24 items. Items are statements about behavior and participants rate each item are scored from 1 (very true for me) to 4 (very false for me). The change in total score is calculated from the difference between baseline to post-intervention assessment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490734


Locations
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United States, North Carolina
Mcgavran-Greenberg Hall Recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Brian Brown, MA    919-843-4975    brianb1@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kyle Burger, PhD University of North Carolina, Chapel Hill

Publications:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03490734     History of Changes
Other Study ID Numbers: 17-0710
1R01DK112317-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
nutrition
obesity
weight gain
sugar
sugar sweetened beverage
dopamine
neurobehavioral adaptation

Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms