SNPMiner Trials (Home Page)
Report for Mutation R24W
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 3 clinical trials
Clinical Trials
1 Mediterranean Diet and Physical Activity: is the Whole Better Than the Sum of Each Part ? Clinical and Mechanistic Perspectives
There is little doubt scientifically that healthy eating, such as adhering to the Mediterranean diet (MedDiet) principles, is key for the prevention of cardiovascular disease (CVD). There is also convincing evidence for a strong inverse relationship between moderate intensity physical activity (PA) and mortality. Surprisingly, no study has yet formally documented how the combination of a MedDiet and regular PA improves cardiometabolic health in high-risk individuals. Why is this an important issue to address? On the one hand, a rigorous demonstration that the combination of a healthy diet and PA is better than the sum of each part in terms of cardiometabolic benefits will underpin the importance of advocating the combination of both modalities systematically to maximize health effects. Alternatively (and provocatively), results showing that healthy eating and PA have non-additive or non-synergistic effects will imply that one needs to adhere to only one of these two lifestyle modalities to maximizes cardiometabolic benefits. The overarching aim of this research is to test the hypothesis that consumption of a MedDiet combined with PA do act synergistically to improve cardiometabolic risk. The investigators hypothesize that healthy eating and PA act in synergy to reduce postprandial lipemia, a powerful independent risk factor for coronary heart disease.
NCT03731013 Cardiometabolic Risk Behavioral: Mediterranean diet (MedDiet) Behavioral: Physical activity (PA) Behavioral: Mediterranean diet and physical activity
Participants' diets will be assessed using a validated web 24-hour recall (R24W), which evaluates the food and beverages consumed during the 24 hours prior to the day they complete the questionnaire. --- R24W ---
Primary Outcomes
Description: Serum TG concentrations (mmol/l) will be measured 4 hours after ingestion of a fatty meal (fat load), at the end of the 16-week intervention in all subjects in each group. The fat load will be conducted 48 hours after the last exercise training session in the PA groups (hence at 16.2 weeks, or 114 days). Analyses will be adjusted for 4-hr postprandial TG values measured at baseline.
Measure: 1. Serum 4-hour post-prandial TG concentrations Time: 16.3 week (114 days)Secondary Outcomes
Description: Fasting serum TG concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting TG values measured at baseline.
Measure: Serum fasting TG concentrations Time: 16 week (112 days)Description: Fasting serum TG concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting TG values measured at baseline.
Measure: Serum fasting TG concentrations Time: 16.3 week (114 days)Description: Fasting serum LDL-C concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting LDL-C values measured at baseline.
Measure: Serum fasting LDL-C concentrations Time: 16 week (112 days)Description: Fasting serum LDL-C concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting LDL-C values measured at baseline.
Measure: Serum fasting LDL-C concentrations Time: 16.3 week (114 days)Description: Fasting serum HDL-C concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting HDL-C values measured at baseline.
Measure: Serum fasting HDL-C concentrations Time: 16 week (112 days)Description: Fasting serum HDL-C concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting HDL-C values measured at baseline.
Measure: Serum fasting HDL-C concentrations Time: 16.3 week (114 days)Description: Fasting serum CRP concentrations (mg/ l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting CRP values measured at baseline.
Measure: Serum fasting CRP concentrations Time: 16 week (112 days)Description: Fasting serum CRP concentrations (mg/ l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting CRP values measured at baseline.
Measure: Serum fasting CRP concentrations Time: 16.3 week (114 days)Description: Fasting serum adiponectin concentrations (mg/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting adiponectin values measured at baseline.
Measure: Serum fasting adiponectin concentrations Time: 16 week (112 days)Description: Fasting serum adiponectin concentrations (mg/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting adiponectin values measured at baseline.
Measure: Serum fasting adiponectin concentrations Time: 16.3 week (114 days)Description: Fasting serum IL-6 concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting IL-6 values measured at baseline.
Measure: Serum fasting IL-6 concentrations Time: 16 week (112 days)Description: Fasting serum IL-6 concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting IL-6 values measured at baseline.
Measure: Serum fasting IL-6 concentrations Time: 16.3 week (114 days)Description: Fasting serum IL-18 concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting IL-18 values measured at baseline.
Measure: Serum fasting IL-18 concentrations Time: 16 week (112 days)Description: Fasting serum IL-18 concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting IL-18 values measured at baseline.
Measure: Serum fasting IL-18 concentrations Time: 16.3 week (114 days)Description: Fasting serum TNF-alpha concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting TNF-alpha values measured at baseline.
Measure: Serum fasting TNF-alpha concentrations Time: 16 week (112 days)Description: Fasting serum TNF-alpha concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting TNF-alpha values measured at baseline.
Measure: Serum fasting TNF-alpha concentrations Time: 16.3 week (114 days)Description: SBP (mmHg) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for SBP values measured at baseline.
Measure: Systolic blood pressure (SBP) Time: 16 week (112 days)Description: SBP (mmHg) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for SBP values measured at baseline.
Measure: Systolic blood pressure (SBP) Time: 16.3 week (114 days)Description: DBP (mmHg) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for DBP values measured at baseline.
Measure: Diastolic blood pressure (DBP) Time: 16 week (112 days)Description: DBP (mmHg) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for DBP values measured at baseline.
Measure: Diastolic blood pressure (DBP) Time: 16.3 week (114 days)Description: Maximal oxygen consumption, a metric of cardiorespiratory fitness, will be measured by a modified Bruce protocol at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for VO2max values measured at baseline.
Measure: Maximal oxygen consumption (VO2max) Time: 16 week (112 days)Description: LV global longitudinal strain in % will be measured using transthoracic echocardiogram and speckle tracking for systolic and diastolic strain/strain rates. Analyses will be adjusted for LV global longitudinal strain values measured at baseline.
Measure: Left ventricular (LV) global longitudinal strain Time: 16 week (112 days)Description: RV global longitudinal strain in % will be measured using transthoracic echocardiogram and speckle tracking for systolic and diastolic strain/strain rates. Analyses will be adjusted for RV global longitudinal strain values measured at baseline.
Measure: Right ventricular (RV) global longitudinal strain Time: 16 week (112 days)Description: Cardiac chamber volumes (cm3) will be measured using transthoracic echocardiogram with pulse-wave, continuous-wave and tissue Dopplers. Analyses will be adjusted for cardiac chamber volumes measured at baseline.
Measure: Cardiac chamber volumes Time: 16 week (112 days)Other Outcomes
Description: Levels of total and abdominal fat (volume in cm3) will be measured at baseline and post-intervention (16 week) by DEXA in all participants. Associations between changes in study outcomes and in body fat distribution will be assessed by correlational and multiple regression analyses
Measure: Change (week 0 vs week 16) in android obesity Time: week 0 and week 16 (112 days)Description: These are exploratory analyses in a subset of participants only. Deep 16S rDNA metagenomic analysis (in feces) as well as analyses of microbiota metabolites and endogenous bioactive lipid mediators in plasma will be used as surrogates of gut microbiota composition and function in these exploratory analyses of between group differences. Analyses will be adjusted for baseline values.
Measure: Gut microbiota Time: 16 week (112 days)2 Healthy for my Baby- A Randomized Controlled Trial Assessing a Preconception Clinically Integrated Technological Intervention to Improve the Lifestyle of Overweight Women and Their Partners
The purpose of this study is to determine whether an intervention combining motivational interviewing and follow-up with a mobile phone application will help overweight women and their partners adopt healthy lifestyle habits in the preconception period. This study will also evaluate the impact of the intervention on the weight, waist circumference, and body fat of women and their partners. Women and their partners will be followed through pregnancy to explore the effects of the intervention on the adequacy of gestational weight gain, rates of pregnancy complications, delivery mode, and infant birth weight.
NCT04242069 Overweight and Obesity Pregnancy Complications Health Behavior Life Style Preconception Care Behavioral: Healthy for my Baby Other: Usual Care MeSH:Pregnancy Complications Overweight
Women's C-HEI score will be measured with two or three online 24 hour dietary recalls (R24W tool) at each time point. --- R24W ---
The C-HEI score will be measured with two or three online 24 hour dietary recalls at each time point (R24W tool). --- R24W ---
Primary Outcomes
Description: Women's C-HEI score will be measured with two or three online 24 hour dietary recalls (R24W tool) at each time point. Value range 0-100 with a higher score indicating better diet quality. The change of the score in time during the preconception period will be compared between the groups.
Measure: Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007 Time: 0, 2, 4, and 6 monthsSecondary Outcomes
Description: Three urine spot samples collected over a week will be pooled after normalizing using refractive index measurement to guide dilution. Around 40 metabolites will be targeted for the quantitative measurement of dietary intake biomarker concentrations.
Measure: Women's Urinary Food exposure Biomarker Profile Time: 0 and 2 months in preconception, 24- 26 weeks in pregnancy.Description: The C-HEI score will be measured with two or three online 24 hour dietary recalls at each time point (R24W tool). Value range 0-100 with a higher score indicating better diet quality.
Measure: Men and Women's diet quality measured with the Canadian-Healthy Eating Index- 2007. Time: 0, 2, 4, and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: Physical activity measured in MET-minutes/week. Value range of 0-5000 MET-minutes/week with a higher score indicating a higher activity level.
Measure: Men and Women's physical activity level measured with the International Physical Activity Questionnaires Short Version. Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: Steps per day measured with a wristband accelerometer over 7 days . Value range 0- 15 000 steps per day with a higher step count indicating a higher activity level.
Measure: Men and Women's steps per day measured with a Fitbit. Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: Minutes of moderate and vigorous physical activity per week measured with a wristband accelerometer over 7 days. Value range 0-800 minutes with a higher number of minutes indicating a higher activity level.
Measure: Men and Women's minutes of moderate and vigorous physical activity measured with a Fitbit. Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: Sleep quality measured with a questionnaire. Value range 0-21 with a higher score indicating lower sleep quality.
Measure: Men and Women's Sleep quality measured with the Pittsburgh Sleep Quality Index Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: Quality of life measured with a questionnaire and reported as a t-score. Value range 0-100 with a higher score indicating better quality of life.
Measure: Men and Women's quality of life measured with the SF-12 v2 Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: Anxiety and Depression symptoms measured with a questionnaire. Value range 0-42 with a higher score indicating more anxiety and depression symptoms.
Measure: Men and Women's Anxiety and Depression symptoms measured with the Hospital Anxiety and Depression Scale. Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: The change in body fat will be assessed in preconception using foot-to-foot bioimpedance.
Measure: Women's body fat percentage. Time: 0, 3, and 6 months in preconception.Description: The change in waist circumference will be assessed in preconception using a measuring tape and a standardized protocol.
Measure: Women's waist circumference in centimeters. Time: 0, 3, and 6 months in preconception.Description: The change in bodyweight will be assessed throughout the study using a calibrated scale.
Measure: Men and Women's weight in kilograms. Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: The change in body fat will be assessed throughout the study using foot-to-foot bioimpedance.
Measure: Men's body fat percentage. Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: The change in waist circumference will be assessed throughout the study using a measuring tape and a standardized protocol.
Measure: Men's waist circumference in centimeters. Time: 0, 3 and 6 months in preconception and 10-12 weeks, 24-26 weeks, and 32-34 weeks in pregnancy.Description: Women's total weight gain in pregnancy will be obtained from their medical file. The proportion of adequate gestational weight gain according to BMI specific recommendations (IOM, 2009) will be compared between groups.
Measure: Proportion of adequate gestational weight gain Time: At delivery.Description: Rates of gestational diabetes (diagnosed with a provoked hyperglycemia test or serial capillary glycemia measures), gestational hypertension (clinical diagnosis), pre-eclampsia (clinical diagnosis), fetal macrosomia (birth weight over the 90th percentile for the gestational age and sex), and mode of delivery.
Measure: Rate of pregnancy complications Time: At delivery.Other Outcomes
Description: Rates of clinical pregnancies (embryo with a positive heartbeat on first trimester ultrasound), spontaneous miscarriage (unviable pregnancy prior to 20 weeks of gestation), and live birth rate.
Measure: Fertility outcomes Time: After 9 months of follow-up.3 Impact of the COVID-19 Pandemic on Diet Quality and Food Insecurity Among Adults From the Province of Québec in Canada: a NutriQuébec Sub-study
The unprecedented confinement and social distancing rules imposed by the fight against COVID-19 has forced the majority of the population worldwide to stay home for periods of time ranging from weeks to months. Eating habits are undoubtedly perturbed during this period, with consequential impact on food security. Therefore, the primary aim of this NutriQuébec sub-study is to document the impacts of the COVID-19 pandemic on diet quality and food insecurity of adults in the province of Québec in Canada. NutriQuébec is a web-based prospective cohort study launched in June 2019 whose primary aim is to provide data for the evaluation of the Government Health Prevention Policy on the Québec population's eating habits over the years (NCT04140071). Participants of NutriQuébec are invited to complete on a web-based platform nine core questionnaires on a yearly basis. Questionnaires assess several dimensions related to lifestyle, including eating habits and physical activity habits, as well as a large number of personal characteristics and global health status. For the purpose of this sub-study, NutriQuebec will invite the 2465 active participants who completed the first-year questionnaires prior to the COVID-19 pandemic to fill out again those questionnaires during the peak period of the confinement period in April and May, 2020. This NutriQuébec sub-study will provide invaluable data on how the COVID-19 pandemic impacts diet quality and food insecurity of adults in the province of Québec.
NCT04371848 Eating Habits
Diet quality during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W). --- R24W ---
Intake of sodium during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W). --- R24W ---
Intake of sugar during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W). --- R24W ---
Intake of saturated fat during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W). --- R24W ---
Intake of vegetables and fruits during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W). --- R24W ---
Intake of dairy products during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W). --- R24W ---
Primary Outcomes
Description: Diet quality during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measure: Change in diet quality Time: 0 to 11 monthsDescription: Food insecurity during the study period will be assessed using the series of questions of the Household Food Security Survey Module from the Canadian Community Health Survey (CCHS)-2017
Measure: Change in food insecurity Time: 0 to 11 monthsSecondary Outcomes
Description: Intake of sodium during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measure: Change in intake of sodium Time: 0 to 11 monthsDescription: Intake of sugar during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measure: Change in intake of sugar Time: 0 to 11 monthsDescription: Intake of saturated fat during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measure: Change in intake of saturated fat Time: 0 to 11 monthsDescription: Intake of vegetables and fruits during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measure: Change in intake of vegetables and fruits Time: 0 to 11 monthsDescription: Intake of dairy products during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measure: Change in intake of dairy products Time: 0 to 11 monthsDescription: Physical activity during the study period will be assessed primarily using the EPIC-Norfolk Work and leisure time physical activity questionnaire, which categorizes participants into one of 4 groups based on physical activity at work and during leisure time: 1- Inactive, 2- Moderately inactive, 3- moderately active, 4- Active.
Measure: Change in physical activity Time: 0 to 11 monthsDescription: Sleep quality during the study period will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire with a score varying between 0 and 21; lower score indicates a better sleep quality.
Measure: Change in sleep quality Time: 0 to 11 monthsDescription: Quality of life during the study period will be assessed using the Short form (SF)-36 health-related quality of life questionnaire, which yields eight subscale scores that are analyzed individually: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each subscale has a score varying between 0 and 100; higher scores indicate a better quality of life for each individual subscale.
Measure: Change in health-related quality of life Time: 0 to 11 months