SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03015012

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Using Personalized Nutrigenomics Testing to Mitigate Overweight/Obesity Risk in Two Distinct Patient Populations: A Multicentre Randomized Clinical Intervention Trial

The investigators hypothesize that compared to the provision of population-based lifestyle advice, providing DNA-based lifestyle advice via personalized nutrigenomics testing (PNT) to two distinct patient populations (Family Health Team patients receiving a lifestyle counselling intervention and transplant recipients) will lead to greater reductions in percent body fat. In addition, it will motivate them to adopt healthier dietary and physical activity habits through changes in attitudes and/or subjective norms and/or behavioural control, lead to greater fat loss (kg), increased percent lean mass and therefore improve health and quality of life outcomes for both patient populations. In addition, it is hypothesized that dietary strategies related to the intake of one or more dietary components of interest will mitigate post-transplant weight gain associated with three SNPs of interest. This is a randomized clinical intervention trial involving a total of four groups of patients (n = 400). The two main patient groups include overweight or obese, stable transplant recipients and overweight or obese patients who are attending group counselling sessions at the East Elgin Family Health Team. Within these two main groups, there will be two sub-groups. Patients will be randomized to receive either PNT or standard nutrition intervention (SNI). Baseline data will be conducted consisting of a food frequency questionnaire and three-day food records using a validated multiple pass method. Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to derive percent body fat and lean mass. Weight and height will be measured using a weigh scale and stadiometer. Attitudes, subjective norms and behavioural control will be assessed using a Theory of Planned Behaviour Questionnaire. Those patients randomized to the PNT group will be instructed on a tailored nutrition care plan and physical activity recommendations based on their individual genetic profile. At the same time, the SNI group will be instructed on general nutrition and physical activity recommendations for weight loss, which include the use of dietary strategies from the standard tool ('Just the Basics') used by registered dietitians for transplant patients and the GLB program for patients attending the East Elgin Family Health Team sessions. Monthly email reminders or phone calls (depending on patient preference) will be sent to transplant recipients as a reminder of their nutrition and physical activity plan. Reminders of nutrition and physical activity goals for the Family Health Team participants are incorporated into the GLB program. Three months, six months and twelve months after baseline data collection and individual nutrition interventions, baseline data will be repeated. After the study is complete, participants in the SNI group will be offered a nutrigenomics report and consultation with a registered dietitian. A paired t-test or repeated measures ANOVA will be used to assess within group change from baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. A repeated measures ANOVA will be used to test between group differences from baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. If significant mean differences are detected, a Tukey's post hoc test will be used to compare differences by group. Statistical significance will be determined by P < 0.05. General linear regression models will be used to assess interactions between each genotype of interest and each dietary component of interest on BMI and body composition from baseline to each follow-up time point.

NCT03015012 Transplant-Related Disorder Overweight and Obesity
MeSH: Obesity Overweight
HPO: Obesity

2 Interventions

Name: Personalized Nutrigenomics Testing (PNT)

Description: Participants will receive nutrition counselling from a registered dietitian based on the results of their personalized nutrigenomics testing. Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program, but will be given personalized nutrition and physical activity advice based on the results of their nutrigenomics test. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.

Type: Genetic

Personalized Nutrigenomics Testing (PNT)

Name: Standard Nutrition Intervention (SNI)

Description: Transplant participants will receive standard nutrition counselling from a registered dietitian focused on strategies from the Canadian Diabetes Association's patient resource 'Just the Basics.' Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the standard GLB Program. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.

Type: Other

Standard Nutrition Intervention (SNI)


Primary Outcomes

Description: Change in body composition (body fat percentage as the primary outcome) will be assessed using BIA which will provide information on fat mass, lean mass, and water weight

Measure: Change in Body Fat Percentage

Time: 3 months, 6 months, 12 months

Secondary Outcomes

Description: Change in dietary intake will be assessed using pre- and post- dietary data collected using 3-day food records, and a past-month online food frequency questionnaire.

Measure: Change in Dietary Intake

Time: 3 months, 6 months, 12 months

Description: Change in physical activity will be assessed using pre- and post- physical activity data collected using a 7-day physical activity recall. Metabolic equivalents will then be calculated from this data.

Measure: Change in Physical Activity

Time: 3 months, 6 months, 12 months

Description: Change in these key components of the Theory of Planned Behaviour (TPB) will be assessed using a TPB questionnaire.

Measure: Change in Attitudes, Subjective Norms and Behavioural Control

Time: Pre- and post- lifestyle intervention (baseline), 3 months, 6 months, 12 months

Description: Change in body composition will be assessed using BIA which will provide information on fat mass, lean mass, and water weight

Measure: Change in Body Composition

Time: 3 months, 6 months, 12 months

Description: Change in BMI will be measured using weight and height data collected using a weigh scale and stadiometer

Measure: BMI

Time: 3 months, 6 months, 12 months

Description: Change in weight will be measured using a weigh scale

Measure: Weight

Time: 3 months, 6 months, 12 months

Other Outcomes

Description: Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.

Measure: Nutrigenomics Interactions

Time: 3 months, 6 months, 12 months

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There are 5 SNPs

SNPs


1 rs1558902

Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.. Inclusion Criteria: - TRANSPLANT PATIENTS: Adults greater than or equal to age 18, non-pregnant, non-lactating, attending Canadian Transplant Association meetings, BMI ≥ 25kg/m2, ≥1 year stable (not being treated for transplant rejection or infection) post-transplant, having access to a computer with email or a telephone at least one day per week and English speaking.

It is also hypothesized that dietary strategies related to the intake of one or more dietary components of interest (protein, monounsaturated fat, polyunsaturated fat, total fat, sodium, carbohydrates, alcohol and calories) will mitigate post-transplant weight gain associated with the following SNPs: ACE (rs4343), FTO (rs1558902) and MC4R (rs571312).

General linear regression models will be used to assess the effect of each genotype of interest (ACE rs4343, MC4R rs573112, FTO rs1558902) and the impact of each dietary component of interest (protein, total fat, saturated fat, unsaturated fat, carbohydrates, alcohol, calories and sodium) on BMI and body composition from baseline to each follow-up time point.


2 rs4343

Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.. Inclusion Criteria: - TRANSPLANT PATIENTS: Adults greater than or equal to age 18, non-pregnant, non-lactating, attending Canadian Transplant Association meetings, BMI ≥ 25kg/m2, ≥1 year stable (not being treated for transplant rejection or infection) post-transplant, having access to a computer with email or a telephone at least one day per week and English speaking.

It is also hypothesized that dietary strategies related to the intake of one or more dietary components of interest (protein, monounsaturated fat, polyunsaturated fat, total fat, sodium, carbohydrates, alcohol and calories) will mitigate post-transplant weight gain associated with the following SNPs: ACE (rs4343), FTO (rs1558902) and MC4R (rs571312).

Similarly, nutrigenomics research in the ACE gene (rs4343) found statistical significance using a sample of n = 104 and an alpha < 0.05.

General linear regression models will be used to assess the effect of each genotype of interest (ACE rs4343, MC4R rs573112, FTO rs1558902) and the impact of each dietary component of interest (protein, total fat, saturated fat, unsaturated fat, carbohydrates, alcohol, calories and sodium) on BMI and body composition from baseline to each follow-up time point.


3 rs571312

Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.. Inclusion Criteria: - TRANSPLANT PATIENTS: Adults greater than or equal to age 18, non-pregnant, non-lactating, attending Canadian Transplant Association meetings, BMI ≥ 25kg/m2, ≥1 year stable (not being treated for transplant rejection or infection) post-transplant, having access to a computer with email or a telephone at least one day per week and English speaking.

It is also hypothesized that dietary strategies related to the intake of one or more dietary components of interest (protein, monounsaturated fat, polyunsaturated fat, total fat, sodium, carbohydrates, alcohol and calories) will mitigate post-transplant weight gain associated with the following SNPs: ACE (rs4343), FTO (rs1558902) and MC4R (rs571312).


4 rs573112

General linear regression models will be used to assess the effect of each genotype of interest (ACE rs4343, MC4R rs573112, FTO rs1558902) and the impact of each dietary component of interest (protein, total fat, saturated fat, unsaturated fat, carbohydrates, alcohol, calories and sodium) on BMI and body composition from baseline to each follow-up time point.


5 rs9939609

Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.. Inclusion Criteria: - TRANSPLANT PATIENTS: Adults greater than or equal to age 18, non-pregnant, non-lactating, attending Canadian Transplant Association meetings, BMI ≥ 25kg/m2, ≥1 year stable (not being treated for transplant rejection or infection) post-transplant, having access to a computer with email or a telephone at least one day per week and English speaking.



HPO Nodes


HPO:
Obesity
Genes 318
MYT1L SOX2 MKRN3 PCSK1 SOX3 MKKS RAB23 GABRD SNORD115-1 SPATA7 SOX10 CERKL PRPF31 LRAT IFT140 ARL2BP PNKP MAK CNNM2 AHI1 ABCA4 PDE4D ZBTB20 PDE6A 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 NDN PRPF6 GCK PSMD12 WNT4 AGBL5 DCC RREB1 PTEN HNF4A SLC10A7 TRIP12 BBS9 TUB MECP2 BDNF SNORD116-1 HESX1 FGF17 MKS1 TULP1 HIRA TNFSF4 BLK GHR SEMA3A XYLT1 ARL6 TTC8 PROM1 BPTF NEK2 ZDHHC15 ANOS1 SAG NEUROD1 KIDINS220 KISS1R PNPLA6 ALMS1 BRAF PROKR2 CANT1 KLHL7 REEP6 UBE3A FAM161A ABCC8 HS6ST1 RBMX KCNJ11 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 USH2A CLRN1 CNGB1 CNGA1 KDM6A NIPBL NR0B2 PHIP TRAPPC9 TBX1 MOG CA4 IMPG2 PDE11A GP1BB RAD21 CUL4B PROK2 NPHP1 FLII CACNA1S IFT27 GNAS-AS1 KLF11 DPYD TBX3 HNF1A BEST1 NR2E3 RAP1A RAP1B MAGEL2 DEAF1 FMR1 COMT OFD1 WDR34 SLC25A4 NRL CLIP2 IFT74 RNPC3 INPP5E SYNE1 NTRK2 DUSP6 LZTFL1 CEP290 RBP3 HGSNAT KCNAB2 WT1 BBIP1 POMC NSD1 KIAA1549 PHF6 BAZ1B RDH12 POMGNT1 PRPH2 SHOX ARHGEF18 PCARE POU3F4 SPG11 CHD7 TMEM43 SIN3A AIP BBS5 H6PD HUWE1 APOE IDH3B PPARG SIM1 RFC2 XRCC4 SLC7A7 GTF2IRD1 SKI PRPF8 ADNP THOC2 CCDC141 CREBBP RGR ZNF365 SLC7A14 JMJD1C SHANK3 LEP WDPCP LEPR CEP164 SH2B1 RHO CRB1 KIF7 BBS10 MKRN3-AS1 MTFMT CRX ZNF711 RLBP1 USP8 MLXIPL LIMK1 SETD2 EYS ARL3 KMT2D IGF1 LIPE OTX2 IGF1R GTF2I IGFALS NSMF EGF SEC24C LMNA MEGF8 GUCA1B IFT88 ARVCF WDR11 SMC3 PRPF4 FEZF1 P2RY11 PRPF3 SETD5 TRIM32 BBS7 ATP6AP2 EIF2S3 ZNF408 ARMC5 SPRY4 DYRK1B EHMT1 PRKAR1A APPL1 FOXP1 ROM1 RP9 RP1 ELN PAX4 RP2 RPGR PAX6 RERE EMD CTNNB1 C8ORF37 KCNJ18 LAS1L TOPORS STX16 IL17RD ERMARD CTSH PRDM16 BBS12 RPE65 SNRNP200 SNRPN TBL2 EP300 VPS13B HCRT AFF4 MAN1B1 RAI1 CEP19 SMAD4 GABRA3 PCNT ZNF513