metabolic syndrom. Metabolic disorder, unspecified
Conditions
Interventions
Intervention 1: intervention group: 1800 mg hydro-alcoholic artichoke leaf extract as 4 tablets per day for 3 months. Intervention 2: Control group: 1800 mg placebo containing corn starch, lactose and
Treatment - Other
Placebo
intervention group: 1800 mg hydro-alcoholic artichoke leaf extract as 4 tablets per day for 3 months
Control group: 1800 mg placebo containing corn starch, lactose and Avicel as 4 tablets per day for 3 months
Sponsors
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: willingness and ability to collaborate on project ; aged between 20-60 years (both sexes); affected by metabolic syndrome: having at least 3 of 5 criteria according to international definition: waist circumference >91 cm in women and >89cm in men, serum glucose =100 mg/dl, serum triglyceride =150 mg/dl, HDL-C >40 mg/dl in men and >50 mg/dl in women, systolic blood pressure = 130 mmHg and/or diastolic blood pressure = 85 mmHg Exclusion criteria: Smoking ; Consumption of fish oil supplement or other antioxidant supplements currently or within 3 months before intervention; Consumption of lipid or blood pressure lowering drugs, corticosteroids currently or within 3 months before intervention; affected by cardiovascular disease, renal failure, diabetes mellitus, liver dysfunction, cancer; affected by Infectious or inflammatory disease or recent surgery; affected by malabsorption, such as sprue and Crohn's disease; affected by hypothyroidism or hyperthyroidism; having gallstones and biliary tract obstruction; having a weight loss diet at the time of the study; pregnancy or lactation; history of allergy to artichoke family plants and their products; menopause
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood suger and Serum Lipid profile. Timepoint: at the beginning and end of intervention. Method of measurement: Fasting blood suger by enzymatic method and triglycerid, total cholestrol and HDL-C by espectrophotometry method and LDL-C by Friedewald Formula.;Serum levels of total antioxidants capacity and Malondialdehyde. Timepoint: at the beginning and end of intervention. Method of measurement: TAC: Espectrophotometry by Rabdox enzymatic kit; MDA: Reaction with thiobarbituric acid by fluorimetry method.;Serum level of CETP. Timepoint: at the beginning and end of intervention. Method of measurement: By Laboratory ELISA Kits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Energy and nutrient intake. Timepoint: 3 times; at first, midst and the end of intervention. Method of measurement: 3 dayes food record was used and analyzed with Nutritionist 4 software.;Serum level of Insulin. Timepoint: at the beginning and end of intervention. Method of measurement: Chemilumines.;Physical activity level. Timepoint: 3 times; at first, midst and the end of intervention. Method of measurement: International questionnaire.;Systolic and Diastolic blood pressure. Timepoint: at the beginning and end of iintervention. Method of measurement: Automatic Blood Pressure Monitoring.;Anthropometric measurements. Timepoint: 3 times during the study: at the beginning, midst and end of intervention. Method of measurement: Anthropometric measurements including weight using calibrated Omron scale with a precision of 0.1 kg and a minimum of clothes, height, waist and hip circumference using a tape measure with an accuracy of 0.1 cm will be done, and BMI will be calculated.;Body composition. Timepoint: 3 times during the study: at the beginning, midst and end of intervention. Method of measurement: Measurement of body composition using Omron Bioelectric Impedance Analyzer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactkhatereh Rezazadeh
Ph.D Student of Nutrition
Outcome results
None listed