SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03490734

Developed by Shray Alag, 2019.
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

Description: 10 oz daily for three weeks

Type: Dietary Supplement

Beverage A (Sweetened)

Name: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar

Description: 10 oz daily for three weeks

Type: Dietary Supplement

Beverage B (Sweetened)

Name: Black Cherry and Orange Flavored Beverage no added sugar

Description: 10 oz daily for three weeks

Type: Dietary Supplement

Beverage A (Unsweetened)

Name: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar

Description: 10 oz daily for three weeks

Type: Dietary Supplement

Beverage B (Unsweetened)

Name: Tasteless Beverage

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

Type: Other

Beverage A (Sweetened) Beverage B (Sweetened) Beverage A (Unsweetened) Beverage B (Unsweetened)


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 post

Secondary 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 baseline

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Description: 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 post

Purpose: 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.



HPO Nodes


HPO:
Increased body weight
Genes 354
MYT1L SOX2 MKRN3 PCSK1 SOX3 MKKS RAB23 GABRD CFH SNORD115-1 SPATA7 PIGN SOX10 CERKL PRPF31 MYF6 LRAT IFT140 ARL2BP PNKP MAK CNNM2 AHI1 ABCA4 PDE4D ZBTB20 PDE6A DIS3L2 ATP7B PDE6G IMPDH1 HDAC4 CEL ATRX TRAF3IP1 PDE6B PDSS1 CYP7A1 INS HLA-DQB1 IFT172 KIZ CDHR1 SMC1A HLA-DRB1 CYP19A1 RPS6KA3 SDCCAG8 IQSEC2 DHX38 APC2 HDAC8 MC4R GATA4 PDX1 IPW BBS1 PWRN1 BBS2 CDH23 BBS4 DHDDS SRY CD46 NDN PRPF6 GCK PSMD12 WNT4 AGBL5 DCC PTCH1 RREB1 PTEN HNF4A SLC10A7 TRIP12 BBS9 TUB MECP2 TRIP4 BDNF SNORD116-1 HESX1 RYR1 FGF17 MKS1 TULP1 HELLPAR HIRA TNFSF4 MEN1 BLK GHR SEMA3A XYLT1 ARL6 TTC8 PROM1 BPTF NEK2 ZDHHC15 ANOS1 SAG UBE2A NEUROD1 KIDINS220 KISS1R PNPLA6 PIGA ALMS1 BRAF PROKR2 CANT1 KLHL7 REEP6 UBE3A FAM161A GLI3 ABCC8 HS6ST1 RBMX KCNJ11 UCP2 MCM3AP SYNE2 UFD1 HACE1 ARNT2 ARL13B NPAP1 SCAPER FSCN2 AHR PRCD KMT2A FGF8 AKT2 FGFR1 FGFR3 TACR3 FLRT3 GNAS HSD11B1 PWAR1 SEMA4A HERC2 MERTK FTO PRMT7 FHL1 TMCO1 USH2A CLRN1 CNGB1 CNGA1 KDM6A NIPBL NR0B2 PHIP TRAPPC9 TBX1 MOG DNM2 CA4 IMPG2 PDE11A GP1BB RAD21 CUL4B PROK2 NPHP1 FLII CACNA1S IFT27 GNAS-AS1 KLF11 DPYD TBX3 PIGL HNF1A BEST1 BIN1 NR2E3 RAP1A RAP1B MAGEL2 DEAF1 FMR1 COMT OFD1 WDR34 SLC25A4 NRL CLIP2 IFT74 RNPC3 INPP5E SYNE1 NTRK2 DUSP6 LZTFL1 CEP290 RNF135 RBP3 HGSNAT KCNAB2 WT1 BBIP1 POMC NSD1 KIAA1549 PHF6 BAZ1B RDH12 POMGNT1 PRPH2 SHOX ARHGEF18 ABCC9 PCARE POU3F4 SPG11 CHD7 TMEM43 SIN3A AIP BBS5 H6PD HUWE1 APOE IDH3B PPARG SIM1 RFC2 XRCC4 SLC7A7 GTF2IRD1 SKI PRPF8 CFI ADNP THOC2 CCDC141 CREBBP RGR ZNF365 SLC7A14 JMJD1C SHANK3 LEP WDPCP LEPR CEP164 SH2B1 EDNRB RHO CRB1 KIF7 BBS10 MKRN3-AS1 MTFMT CRX ZNF711 RLBP1 AP4E1 USP8 MLXIPL LIMK1 SETD2 EYS AP4S1 ARL3 PIGT KMT2D IGF1 LIPE OTX2 IGF1R GTF2I IGFALS THRA NSMF EGF SEC24C LMNA MEGF8 GUCA1B MTMR14 IFT88 ARVCF WDR11 SMC3 PRPF4 FEZF1 P2RY11 PRPF3 SETD5 TRIM32 MTOR BBS7 ATP6AP2 EIF2S3 ZNF408 ARMC5 SPRY4 DYRK1B PRKACA EHMT1 PRKAR1A FIBP APPL1 FOXP1 ROM1 RP9 RP1 ELN PAX4 RP2 RPGR PAX6 RERE EMD AP4M1 CTNNB1 C8ORF37 KCNJ18 IGSF1 AP4B1 LAS1L TOPORS STX16 SUFU IL17RD ERMARD CTSH PRDM16 BBS12 RPE65 SNRNP200 SNRPN TBL2 EP300 VPS13B HCRT AFF4 MAN1B1 TP53 RAI1 CEP19 SMAD4 GABRA3 PCNT ZNF513