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Report for Clinical Trial NCT03490734
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment
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).
NCT03490734 Obesity Weight Gain MeSH:Weight Gain
HPO:Increased body weight
5 Interventions
Name: Black Cherry and Orange Flavored Beverage with added sugar
Name: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar
Name: Black Cherry and Orange Flavored Beverage no added sugar
Name: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar
Name: Tasteless Beverage
Primary Outcomes
Description: 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.
Measure: 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: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postSecondary Outcomes
Description: 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.
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 Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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
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 Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
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 Body Mass Index (BMI) Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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).
Measure: Change in Stop Signal Reaction Time to Logo as Measured in Behavioral Response Inhibition Task Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change score in Visual Analog Scale Ratings of Beverage Perceptual Measures Time: Baseline Assessment; Intervention Visits 1-9, 3 weeks; Post-Intervention Assessment, approx. 5 weeks post baselineDescription: 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.
Measure: Change in Food Pattern From Baseline to Post-Intervention Assessment by Food Frequency Questionnaire Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change in Beverage Intake Pattern From Baseline to Post-Intervention Assessment by Beverage Intake Questionnaire Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change in Physical Activity From Baseline to Post-Intervention Assessment by Minnesota Leisure-Time Activity Questionnaire Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change in Restrained Eating Subscale Score as measured on Dutch Eating Behavior Questionnaire Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
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 Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change in Hedonic Hunger as assessed by the Power of Food Scale (PFS) Score Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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
Measure: Change in Food Habits as assessed by the Yale Food Addiction Scale Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change in General Impulsivity as assessed by the Barrett Impulsiveness Scale Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change in General Sensitivity to Reward and Sensitivity to Punishment as assessed by the Sensitivity to Punishment and Sensitivity to Reward Questionnaire. Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postDescription: 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.
Measure: Change in Behavioral Approach and Behavioral Inhibition as assessed by the BIS/BAS Scales Time: Baseline Assessment; Post-Intervention Assessment, approx. 5 weeks postPurpose: Diagnostic
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs1800497
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.