SNPMiner Trials (Home Page)
Report for Mutation W64R
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 Effect of Nutritional Intervention and Olive Oil in Severe Obesity: Randomized Controlled Trial
Obesity is a worldwide epidemic with increasing prevalence, specially severe obesity (Body Mass Index (BMI) ≥ 35 kg/m2). It is a multifactorial disease that involves genetic and environmental factors that lead to increased mortality from cardiovascular disease, diabetes, cancer, among others and impairs life quality. Most research on severe obesity focuses on surgical alternatives and their results, thus this clinical trial aims to evaluate the effect of a non-pharmacological approach based on nutritional intervention and supplementation with a functional food, the olive oil. It will analyze the effectiveness of interventions on: weight loss, improvements on body composition and inflammatory profile (TNF-alfa, interleucins 1, 6 and 10, adiponectin), insulin resistance and serum lipids control, changing eating habits and physical activity practice, modification on bone mineral density and sarcopenia, and reduction of cardiovascular risk and other diseases. Also, it will be investigated the influence of polymorphisms (Pro12Ala of PPAR-γ gene, -174G>C of IL6 gene e Trp64Arg of ADRB3 gene) on nutritional intervention effectiveness with and without olive oil. This research looks for improving severely obese patient's care and contributing to effective results by reducing costs and risk treatment. The investigators believe that this informations will contribute significantly to the scientific field, expanding the knowledge about severe obesity.
NCT02463435 Severe Obesity Behavioral: Nutritional intervention Other: Nutritional intervention plus olive oil Dietary Supplement: Olive oil MeSH:Obesity Obesity, Morbid
HPO:Obesity
Also, it will be investigated the influence of polymorphisms (Pro12Ala of PPAR-γ gene, -174G>C of IL6 gene e Trp64Arg of ADRB3 gene) on nutritional intervention effectiveness with and without olive oil. --- Pro12Ala --- --- Trp64Arg ---
Primary Outcomes
Description: Measurements of weight, arm circumference and Body Mass Index (BMI) will be evaluated to assess anthropometric change.
Measure: Anthropometric measurements change Time: Baseline, week 12Description: Body fat mass (BFM), body fat percentage (%BF) and body mass density (BMD) will be evaluated to assess body composition change. BFM and %BF will be assessed using multifrequency bioelectrical impedance analysis (BIA) and dual energy X-ray absorptiometry (DXA) and BMD will be assessed using DXA.
Measure: Body composition change Time: Baseline, week 12Secondary Outcomes
Description: TNF-alfa, interleucin 6 (IL6), IL1, IL10, adiponectin, C-reactive protein (CRP)
Measure: Change in inflammation parameters Time: Baseline, week 12Description: Lipid profile (total cholesterol, LDL-c, HDL-c, VLDL-c), insulin resistance (HOMA-IR, glycated hemoglobin), fasting glycaemia, hemogram
Measure: Change in metabolic parameters Time: Baseline, week 12Description: Creatinine, urea and uric acid
Measure: Change in kidney function Time: Baseline, week 12Description: AST and ALT
Measure: Change in liver function Time: Baseline, week 12Description: TSH, T4 and parathyroid hormone
Measure: Change in thyroid function Time: Baseline, week 12Description: Vitamin D, vitamin B12 and folic acid
Measure: Change in vitamins Time: Baseline, week 12Description: Iron, calcium, sodium, potassium and zinc
Measure: Change in minerals Time: Baseline, week 12Measure: Change in cardiovascular risk using Global Risk Score (GRS) Time: Baseline, week 12
Measure: Change in cardiovascular risk using Framingham Risk Score (FRS) Time: Baseline, week 12
Measure: Change in cardiovascular risk using heart rate variability (HRV) Time: Baseline, week 12
Measure: Change in cardiovascular risk using Homocystein level Time: Baseline, week 12
Description: Difference in responses between intervention groups for anthropometric measurements (weight, arm circumference and body mass index) and body composition variables (body fat mass and body fat percentage) according to this polymorphism
Measure: Polymorphism Pro12Ala of Peroxisome Proliferator-Activated Receptor Alfa (PPAR-alfa) Time: Baseline, week12Description: Difference in responses between intervention groups for anthropometric measurements (weight, arm circumference and body mass index) and body composition variables (body fat mass and body fat percentage) according to this polymorphism
Measure: PolymorphismTrp64Arg of Beta-3 Adrenergic Receptor (ADRB3) gene Time: Baseline, week12Description: Difference in responses between intervention groups for anthropometric measurements (weight, arm circumference and body mass index) and body composition variables (body fat mass and body fat percentage) according to this polymorphism
Measure: Polymorphism -174G>C of Interleukin 6 (IL6) gene. Time: Baseline, week12Measure: Change in physical activity practice using Global Physical Activity Questionnaire Time: Baseline, week 12
Measure: Change in physical activity practice using accelerometry Time: Baseline, week 12
Measure: Change in food intake using Food Frequency Questionnaire Time: Baseline, week 12
Measure: Change in food intake using 24 hour recall Time: Baseline, week 12
Description: Change in the following variables: bone density using DXA, falls and fractures and sun exposure
Measure: Change in bone health parameters Time: Baseline, week 12Measure: Change in obesity sarcopenia using muscle mass (evaluated using DXA) Time: Baseline, week 12
Measure: Change in obesity sarcopenia using handgrip strength Time: Baseline, week 12
Measure: Change in sarcopenia using usual gait speed Time: Baseline, week 12
Description: It will be evaluated through changes in food consumption (food frequency questionnaire)
Measure: Adherence to nutritional intervention Time: Baseline, week 12Description: It will be evaluated through attendance to the clinic visits
Measure: Adherence to the health service Time: Baseline, week 12Measure: Change in symptoms of anxiety and depression using Hospital Anxiety and Depression Scale Time: Baseline, week 12
Measure: Change in symptoms of binge eating disorderusing Binge Eating Disorder Scale Time: Baseline, week 12
Measure: Change in musculoskeletal pain using Visual Analog Scale Time: Baseline, week 12
Measure: Change in musculoskeletal pain using Nordic Musculoskeletal Questionnaire Time: Baseline, week 12