]>
IRCT2014052014521N3 IRCT 2014-08-11 Mashhad University of Medical Sciences Comparison of curcumin’s effects in simple and modified formulations in patients with metabolic syndrome Comparison of curcumin’s effects in simple and modified formulations on cardiovascular risk factors in patients with metabolic syndrome 2014-08-23 anticipated 120 Complete https://irct.ir/trial/14137 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Obesity. Condition 2: Non-insulin-dependent diabetes mellitus. Condition 3: hypertriglyceridaemia. Condition 4: hypertension. Condition 5: High-density lipoprotein deficiency. Intervention 1: Simple Curcumin (unformulated). Intervention 2: Control group: placebo for 6 weeks. Intervention 3: Curcumin-phospholipid complex.
public Dr. Amirhossein Sahebkar
Biotechnology Department, School of Medicine, Vakilabad blvd
Mashhad Iran (Islamic Republic of) +98 51 1800 2288 sahebkara@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Amirhossein Sahebkar
Biotechnology Department, School of Medicine, Vakilabad blvd
Mashhad Iran (Islamic Republic of) +98 51 1800 2288 sahebkara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria : Men and women aged 18-65 years ; Metabolic Syndrome patients (based on IDF guidelines) ; Consent to participate in research project ; Not taking any dietary supplement ; Not taking any drugs within the last 3-6 months (Not history of taking any lipid-lowering, diabetes and hypertension drugs or insulin within the last 3-6 months) . Exclusion criteria : Lack of informed consent of patient to participate in research project ; Having systemic disease or history of systemic disease (such as lupus and kidney disease) ; Not having Metabolic Syndrome ; Pregnancy or lactation ; Consumption of any drug supplement or lipid-lowering drug within the last 3-6 months ; Metabolic syndrome subjects who need to take any drug (based on American Heart Association guidelines) . 18 years 65 years Both E66 E11 E78.1 I10 E78.6 Obesity Non-insulin-dependent diabetes mellitus Pure hyperglyceridaemia Essential (primary) hypertension Lipoprotein deficiency Treatment - Drugs Placebo Treatment - Drugs Simple Curcumin (unformulated) Control group: placebo for 6 weeks Curcumin-phospholipid complex Triglycerides. Timepoint: Baseline, week 6. Method of measurement: Routine enzymatic methods using standard biochemistry kits on an autonalyzer. Apo B. Timepoint: Baseline, week 6. Method of measurement: ELISA. Apo A. Timepoint: Baseline, week 6. Method of measurement: ELISA. Adiponectin. Timepoint: Baseline, week 6. Method of measurement: ELISA. CETP. Timepoint: Baseline, week 6. Method of measurement: ELISA. HS-CRP. Timepoint: Baseline, week 6. Method of measurement: immunoturbidimetric assay. Lp (a). Timepoint: Baseline, week 6. Method of measurement: ELISA. CBC. Timepoint: Baseline, week 6. Method of measurement: Sysmex KX-21 Hematology Analyzer. Total cholesterol. Timepoint: Baseline, week 6. Method of measurement: Routine enzymatic methods using standard biochemistry kits on an autonalyzer. HDL-c. Timepoint: Baseline, week 6. Method of measurement: Routine enzymatic methods using standard biochemistry kits on an autonalyzer. LDL-c. Timepoint: Baseline, week 6. Method of measurement: Routine enzymatic methods using standard biochemistry kits on an autonalyzer. Prooxidant-antioxidant balance. Timepoint: Baseline, week 6. Method of measurement: Colorimetric assay. PON. Timepoint: Baseline, week 6. Method of measurement: ELISA. Anti- HSP27. Timepoint: Baseline, week 6. Method of measurement: ELISA. Interleukin-1β (IL-1β). Timepoint: Baseline, week 6. Method of measurement: biochip array immunoassay. Interleukin-1α (IL-1α). Timepoint: Baseline, week 6. Method of measurement: biochip array immunoassay. Interleukin-6 (IL-6). Timepoint: Baseline, week 6. Method of measurement: biochip array immunoassay. Tumor necrosis factor (TNF-α). Timepoint: Baseline, week 6. Method of measurement: biochip array immunoassay. Intercellular Adhesion Molecule-1 (ICAM-1),. Timepoint: Baseline, week 6. Method of measurement: ELISA. L-Selectin. Timepoint: Baseline, week 6. Method of measurement: ELISA. Anxiety. Timepoint: Baseline, week 6. Method of measurement: Questionnaire. Depression. Timepoint: Baseline, week 6. Method of measurement: Questionnaire. Vascular Cell Adhesion Molecule-1 (VCAM-1). Timepoint: Baseline, week 6. Method of measurement: ELISA. Mashhad University of Medical Sciences Approved 2014-01-20 Mashhad University of Medical Sciences Daneshgah Street Mashhad Iran (Islamic Republic of)