Nutrigenomics, Overweight/Obesity and Weight Management Trial (NOW Trial)

NCT ID: NCT03015012


Title
Using Personalized Nutrigenomics Testing to Mitigate Overweight/Obesity Risk in Two Distinct Patient Populations: A Multicentre Randomized Clinical Intervention Trial
Purpose
The investigators hypothesize that compared to the provision of population-based dietary advice, providing DNA-based dietary advice via personalized nutrigenomics testing (PNT) to 2 distinct patient populations (prediabetes patients and transplant recipients) will motivate them to adopt healthier dietary habits, lead to greater fat loss, increased percent lean mass and therefore improve health and quality of life outcomes for both patient populations. The second hypothesis is 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 = 300). The two main patient groups include overweight or obese stable transplant recipients and overweight or obese patients who have been diagnosed with prediabetes. Within these two main groups, there will be two sub-groups. Patients in each of the two main groups will be randomized to receive either PNT or standard nutrition intervention (SNI). Baseline data will be conducted consisting of a 24-hour recall and 3-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. Those patients randomized to the PNT group will be instructed on a tailored nutrition care plan based on their individual nutrigenomics profile. At the same time, the SNI group will be instructed on general nutrition recommendations for weight loss using the standard tool ('Just the Basics') used by registered dietitians for transplant patients and prediabetes patients. Monthly email reminders will be sent to all participants as a reminder of their nutrition plan. 6-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 test and consultation with a registered dietitian. A paired t-test will be used to assess within group change from baseline to 6-month follow-up for: BMI, body fat, lean mass, and dietary intake. A repeated measures ANOVA will be used to test between group differences from baseline to 6-month follow-up 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 6-month follow-up.
Details
Hypotheses: Compared to the provision of population-based dietary advice, providing DNA-based dietary advice via personalized nutrigenomics testing (PNT) to 2 distinct patient populations (prediabetes patients and transplant recipients) in which overweight and obesity are common concerns, will motivate them to adopt healthier dietary habits, lead to greater fat loss, increased percent lean mass and therefore improve health and quality of life outcomes for both patient populations. The second hypothesis is that dietary strategies related to the intake of one or more dietary components of interest (protein, fat, monounsaturated fat, polyunsaturated fat, total fat, sodium and calories) will mitigate post-transplant weight gain associated with the following SNPs: ACE (rs4343), FTO (rs1558902) and MC4R (rs571312). Sample Size: No research to date has studied the aforementioned hypotheses. Previously published data assessing weight loss in a SNI group compared to a PNT group using a randomized clinical intervention model in a different population used a sample of n = 93 and an alpha < 0.05 to find statistical significance after 3-7 month follow-up. Similarly, nutrigenomics research in the ACE gene (rs4343) found statistical significance using a sample of n = 104 and an alpha < 0.05. Since it is feasible for this research, a larger sample size (n = 300) will be used to increase power and draw meaningful inferences from the data. There will be 150 participants in each patient group in this landmark study. Design and Methods: Participants will be recruited from the Canadian Transplant Association meetings (transplant recipients; n = 150) and from Prediabetes Group Programming at the East Elgin Family Health Team (prediabetes patients; n = 150) for this randomized clinical intervention trial. This trial involves a total of four groups of patients. The two main patient groups include overweight or obese (BMI ≥ 25 kg/m^2) stable transplant recipients greater than or equal to 1 year post-transplant and overweight or obese (BMI ≥ 25 kg/m^2) patients who have been diagnosed with prediabetes. Within these two main patient groups, there will be two sub-groups (n = 75 per group). Patients in each of the two main groups will be randomized to receive either PNT or standard nutrition intervention (SNI) using the standard teaching tool used by dietitians in both patient populations: 'Just the Basics' - developed by the Canadian Diabetes Association. Baseline data will be conducted consisting of a 24-hour recall and 3-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. Those patients randomized to the PNT group will be instructed on a tailored nutrition care plan based on their individual nutrigenomics profile. At the same time, the SNI group will be instructed on general nutrition recommendations for weight loss using the teaching tool 'Just the Basics.' Monthly email reminders will be sent to all participants as a reminder of their nutrition plan. 6-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 test and consultation with a registered dietitian. Statistical Analysis: A paired t-test will be used to assess within group change from baseline to 6-month follow-up for: BMI, body fat, lean mass, water weight, and dietary intake (protein, total fat, saturated fat, trans fat, unsaturated fat, carbohydrates, calories and sodium). A repeated measures ANOVA will be used to test between group differences from baseline to 6-month follow-up for: BMI, body fat, lean mass, water weight, and dietary intake (protein, total fat, saturated fat, trans fat, unsaturated fat, carbohydrates, calories and sodium). If significant mean differences are detected, a Tukey's post hoc test will be utilized to compare differences by group. Statistical significance will be determined by P < 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, trans fat, unsaturated fat, carbohydrates, calories and sodium) on BMI and body composition at from baseline to 6-month follow-up. We will control for age, sex, ethnicity, immunosuppressive medications and baseline body composition and BMI. IBM SPSS Statistics, version 21.0 will be used for the data analysis.
Conditions
Transplant-Related Disorder, PreDiabetes, Overweight and Obesity
Keywords
Nutrigenomics, Genetics, Overweight, Obesity, Prediabetes, Transplantation, Nutrition, Dietetics, BMI, Body Composition
Source
Western University, Canada
Sponsors
Western University, Canada, Nutrigenomix Inc., East Elgin Family Health Team, Canadian Transplant Association
Status
Not yet recruiting
Acronym
NOW
Last Updated
17 Jan 2017
URL
Official Link
Citations/Publications
DiCecco SR, Francisco-Ziller N. Obesity and organ transplantation: successes, failures, and opportunities. Nutr Clin Pract. 2014 Apr;29(2):171-91. doi: 10.1177/0884533613518585. Review.

Arkadianos I, Valdes AM, Marinos E, Florou A, Gill RD, Grimaldi KA. Improved weight management using genetic information to personalize a calorie controlled diet. Nutr J. 2007 Oct 18;6:29.

Caprioli J, Mele C, Mossali C, Gallizioli L, Giacchetti G, Noris M, Remuzzi G, Benigni A. Polymorphisms of EDNRB, ATG, and ACE genes in salt-sensitive hypertension. Can J Physiol Pharmacol. 2008 Aug;86(8):505-10. doi: 10.1139/Y08-045.

Locations
Canada