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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

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 A (Unsweetened) Beverage B (Sweetened) 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 513
MTMR14 PDE6A IDH3A ALG13 CANT1 PRKAR1A WDR34 PCARE EIF2S3 RP1 CTSH RAI1 PIGL LZTFL1 MTFMT TTC8 PPARG ANOS1 IQSEC2 IQSEC2 C8ORF37 TMEM67 RNPC3 MKRN3 FLRT3 MYT1L SNRNP200 BBS4 IFT172 CEP19 PROKR2 EMD EYS SLC25A4 LEPR KIDINS220 THOC2 PCSK1 PRPF4 ARL6 USP9X RDH12 IGF1 IFT172 ARL3 SOX10 PDE11A FGFR3 NR2E3 CUL4B RAB23 PAX6 ARL2BP DYRK1B GNAS GLI3 PRPF31 PNPLA6 SUFU PRCD RLBP1 FTO KLF11 TBX1 BLK INPP5E HIRA CYP7A1 TMEM43 DHDDS MEN1 BBS5 KCNJ11 MLXIPL LEP CLIP2 WNT4 IFT140 RP2 REEP6 TRIP4 EP300 FHL1 PDE4D SH2B1 CNGA1 CNNM2 PAK3 BRAF TNFSF4 IQSEC2 SDCCAG8 MOG TRAPPC9 SDC3 HLA-DQB1 TBL2 POMC ALMS1 PTCHD1 PRPH2 PSMD12 SH3KBP1 SNORD115-1 HSD11B1 ARVCF PRPF8 POMC GUCA1B ATRX SEC24C POMGNT1 ZNF365 SUFU ARMC5 CLCN4 HACE1 RBMX AP4E1 KIAA1549 SLC9A7 SH2B1 IFT27 GNAS EIF2S3 JMJD1C FGF17 COMT MKS1 ZNF81 HERC2 SKI CYP19A1 MKKS SOX2 ATP7B SLC7A7 GTF2I AKT2 MID2 SIM1 SMARCB1 DNMT3A ENPP1 PRPF6 ZNF408 PRDM16 FGFR1 PROM1 ERMARD BBS10 AIP HNF4A NPAP1 BEST1 GATA4 BBS1 ABCC8 TUB THOC2 P4HTM TBX3 KMT2A BBS7 GABRD GP1BB WDR11 RP9 AP4M1 GNAS XRCC4 IGSF1 PAX6 SDCCAG8 RBP3 ADRB3 GNAS PAX4 NSMF NPHP1 RAI1 ATP6AP2 GNAS-AS1 MTOR USP8 MAK KCNJ18 CCDC141 IMPDH1 PDSS1 NIPBL ADNP DPYD SETD2 NR0B2 MED12 NDN FAM161A HESX1 NRL BBS10 GHRL DUSP6 LAS1L PRKACA MKKS P2RY11 BBS5 MEGF8 ZNF711 RREB1 H6PD PIGA HESX1 SIN3A CNKSR2 KIDINS220 BBS12 FRMPD4 IFT74 TRIM32 BLK AFF4 POGZ ALB GABRA3 TSPAN7 SLC10A7 SYNE2 CREBBP GNAS RPS6KA3 ANK3 OFD1 IFT172 APC2 PRKAR1A RPGR BBS9 SNORD116-1 IL1RAPL1 OTX2 NSD1 HACE1 PCSK1 FGFR1 SETD2 BAZ1B EHMT1 UBE2A ZNF41 HNF1A EDNRB INS PROK2 POU3F4 IFT88 PDE6B GNAS ABCC8 RGR ARL13B KMT2D GHR GNAS NEK2 RFC2 CA4 LIPE RERE MAPK8IP3 RHO SCAPER THRA BPTF RAP1A DLG3 BBS9 PCNT LEP IGFALS CRB1 RPS6KA3 TBX1 NEUROD1 CEP164 GTF2IRD1 RAI1 SIM1 MECP2 FIBP ARX SMC3 PHIP TRIP12 DNM2 CARTPT NTRK2 HELLPAR HDAC8 AGTR2 SEMA3A BRAF AHR PWRN1 CFH OFD1 SETD5 ADNP LZTFL1 PROK2 ABCC8 KISS1R CEP290 MTOR HS6ST1 CDHR1 AP4B1 DEAF1 MAN1B1 RAP1B CTNNB1 TMCO1 USP8 BBS2 GCK UPF3B ELN MAN1B1 PTEN TRIM32 CFI MKS1 ROM1 AP4S1 BBS2 LEPR KCNJ11 MRAP2 PRPF3 CD46 PDGFB LRAT TRAF3IP1 HDAC8 SPRY4 ELN SRY FEZF1 VPS13B TACR3 KIF7 TAF1 RAB23 FOXP1 HDAC8 CERKL CLRN1 AGRP BBS2 MOG TOPORS ARNT2 ARHGEF6 FMR1 USP27X SHANK3 PIGN XYLT1 TP53 VPS13B SMAD4 UFD1 EGF UCP3 BBS12 IFT172 ABCC9 SNRPN CACNA1S USH2A HNF1A ACADVL ADRB2 MEGF8 C8ORF37 APOE WDPCP IGF1R CCDC141 NIN IPW MAGEL2 GDI1 NF2 HGSNAT ARL6 UCP2 HUWE1 PIGT RYR1 SEMA4A EHMT1 SYP IDH3B PRMT7 CEP290 PCNT SH2B1 HDAC4 ADCY3 TTC8 CHD7 AKT2 ABCA4 LMNA HCRT MC4R DMD ZNF513 BIN1 CRX SYNE1 XYLT1 BDNF TBX3 MC3R KLHL7 DCC SPG11 RNF135 TTC8 POMC ALMS1 FTSJ1 PDX1 KDM6A LIMK1 BBIP1 BBS7 RPE65 CCDC28B EXOC6B BBIP1 PTCH1 AHI1 ARMC5 AGBL5 PDE4D TULP1 SMC1A DHX38 CEL ARL6 MAGEL2 PROKR2 HLA-DRB1 MKRN3-AS1 SHOX RAD21 IMPG2 HNF4A ZNF711 C8ORF37 IFT27 PWAR1 MYF6 PNKP FGF8 DIS3L2 HNF4A CDH23 BBS1 WT1 GNAS MTTP ZBTB20 KIZ APPL1 FLII IL17RD SPATA7 MERTK KCNJ11 TCF20 MECP2 CXORF56 LMNA BBS4 SLC7A14 SOX3 MC4R LAS1L KCNAB2 CUL4B PDE6G ARHGEF18 SAG RAB39B STX16 UBE3A ACSL4 TBX1 MCM3AP TUB ATRX FSCN2 PHF6 TRAPPC9 PHF6 WT1 CNGB1 HCFC1