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IRCT201608223320N13 IRCT 2016-11-03 Nutrition Research Center, Tabriz University of Medical Scienses Effect of vitamin D on obesity Effects of vitamin D supplementation on sirtuin-1, Angiogenesis factors and Matrix metalloproteinases enzmes in Obese subjects with Vitamin D Insufficiency/ Deficiency 2016-10-22 anticipated 44 Complete https://irct.ir/trial/3409 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A obesity. Intervention 1: Intervention groups: receive 50000 IU vit D as blues along with low calorie diet for 12 weeks. Intervention 2: Control group: receive placebo of vitamin D (edible paraffin) with low calorie diet for 12 weeks.
public Soodabeh Aliashrafi
Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street.
Tabriz Iran (Islamic Republic of) +98 41 3335 7581 SA.NUT89@yahoo.com Faculty of Nutrition and food science, Tabriz University of Medical Scienses scientific Dr. Mehrangiz Ebrahimi Mamagani
Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street
Tabriz Iran (Islamic Republic of) +98 413335229500 ebrahimimamagani@tbzmed.ac.ir Faculty of Nutrition and food science, Tabriz University of Medical Scienses Iran (Islamic Republic of) Inclusion criteria: age of 18-60; BMI= 30-40 Kg/m2; Serum Vitamin D < 50 nmol/L and interesting in participation in research. Exclusion criteria: Alcohol consumption; smoking; pregnant; lactating; menopausal women; very active subjectes or athletes; diet 3 mounts before research ; Glucose and lipid lowering Drugs ; antihypertensive medication; consumption vit D supplementation and multivitamin mineral during research; use of medication affecting Vitamin D metabolism; subjects suffering from metabolic disease ;cardiovascular diseases;renal diseases ; nephrolithiasis; liver diseases; thyroid disease; autoimmune disease; cancer. 18 years 60 years Both E66.0 Obesity due to excess calories Prevention Prevention Intervention groups: receive 50000 IU vit D as blues along with low calorie diet for 12 weeks Control group: receive placebo of vitamin D (edible paraffin) with low calorie diet for 12 weeks. Inflammatory factors (MCP-1, IL-1 beta). Timepoint: Beginning and end of the intervention. Method of measurement: ELISA Kit. Serum Angiogenesis factors. Timepoint: Beginning and end of the intervention. Method of measurement: ELISA Kit. Matrix metalloproteinases (MMP-2, MMP-9). Timepoint: Beginning and end of the intervention. Method of measurement: ELISA Kit. Sirtuin-1 (Sirt-1). Timepoint: Beginning and end of the intervention. Method of measurement: ELISA Kit. Toll like receptor-4 (TLR-4). Timepoint: Beginning and end of the intervention. Method of measurement: ELISA Kit. Serum level of Vitamin D, calcium, Phosphorus and PTH hormon. Timepoint: Begining and end of intervention. Method of measurement: Vitamin D and PTH by using ELISA, calcium and Phosphorus by using spectrophotometry. Fasting Blood Sugar (F.B.S.). Timepoint: Begining and end of intervention. Method of measurement: Enzymatic method. Lipid profile (TC,LDL-c, HDL-c, TG). Timepoint: Begining and end of intervention. Method of measurement: Triglyceride, total cholesterol and HDL-cholesterol with enzymatic colorometric and LDL-cholesterol with Friedewald equation. Serum insulin level and Insulin resistance. Timepoint: Begining and end of intervention. Method of measurement: insulin by using Elisa and Insulin resistance by Calculation of HOMA-IR. Anthropometric measurements. Timepoint: Begining and end of intervention. Method of measurement: Weight and Height by using Seca scale and stadiometer respectively, waist to hip ratio will be calculated waist circumference divided to hip circumferenceas, Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters, fat mass and visceral fat mass by using body Analyser. Energy , macro and micro nutrients intake. Timepoint: Baseline, 6 weeks and end of the intervention. Method of measurement: 3 day Dietary record questionnair. Physical activity level. Timepoint: Baseline, 6 weeks and end of the intervention. Method of measurement: International physical activity questionnaire. Nutrition Research Center, Tabriz University of Medical Scienses Approved 2016-10-16 The Research Ethics Committee of Tabriz University of Medical Sciences Faculty of Nutrition and food science, Attarneyshabouri street, Golgasht street. Tabriz Iran (Islamic Republic of)