A clinical trial to assess the Efficacy and safety of liposomal Curcumin in subjects with metabolic syndrome

INTERVENTION: Intervention1: Liposomal Curcumin: strength: 100 mg of Curcumin per 5 ml, route: Oral, Frequency: 4 times x 5mL per day; Duration: 6 weeks Control Intervention1: Curcumin (Non Liposomal Curcumin): strength: 100 mg of Curcumin per 5 ml, route: Oral, Frequency: 4 times x 5mL per day; Duration: 6 weeks CONDITION: Metabolic syndrome PRIMARY OUTCOME: Inflammatory marker C‐reactive protein (CRP) at baseline and 6 weeks.‐‐‐‐‐‐Timepoint: Inflammatory marker C‐reactive protein (CRP) at baseline and 6 weeks. SECONDARY OUTCOME: Plasma tumor necrosis factor alpha at baseline and 6 weeks ; Plasma interleukine 6 at Baseline and 6 weeks ; Body weight, anthropometric assessments, ; Biochemistry and lipis profile assessment baseline and 6 weeks ; Incidence rates of adverse event and changes in vital signs ; Blood Hematology assessment ; Quality of life using SF‐36 questionnaire‐‐‐‐‐‐Timepoint: Baseline (Day 0) and Day 42 INCLUSION CRITERIA: 1. 18 years of age and above 2. Metabolic abnormalities with or without alcohol consumption and/or smoking 3. Diagnosis of MetS ie. the presence of three or more criteria of the modified National Cholesterol Education Programs Adult Treatment Panel III ( NCEP ATP III): 3.1 Waist circumference 90 cm in men and 80 cm in women 3.2 Hypertriglyceridemia â?¥ 150 mg/dl 3.3 High density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females 3.4 Blood pressure â?¥ 130/85 mm Hg 3.5 Fasting plasma glucose â?¥ 110 mg/dl 4.0 Patients willing to provide written informed consent