Effect of herbal supplement based on traditional medicine versus placebo with weight loss diet on some biochemical parameters & Anthropometric indices in obese subjects
- Conditions
- Obesity.Obesity due to excess calories
- Registration Number
- IRCT201307272017N17
- Lead Sponsor
- utrition Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 68
Having BMI more than or equal 30; Age between 20 to 50 years old; Inform consent signed by the patient; Those who can over the next two months two times refer for take drugs and laboratory examination ; Waist circumference > 102 cm (men) or > 88 cm (women).
Inform consent not signed by the patient; Those who can not over the next two months two times refer for take drugs and laboratory examination; Heavy Smoking(More than twenty cigarettes per daily); Diabetes mellitus; Patients with coronary heart vascular disease ;Patients with proven malignancy; Asthma; Chronic cough; Chronic lung inflammatory and bowel disease; Fever of unknown origin; Patients with a history of chronic kidney and liver disease(Exception fatty liver and not including obesity, allergies, skin problems, or occasional GERD or IBS symptoms); Obesity due to endocrine (hypothyroidism, uncontrolled disease) disease.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anthropometric measurements. Timepoint: 2 Times during the study: at the beginning and end of intervention. Method of measurement: Anthropometric measurements including weight using calibrated Seca scale with a precision of 0/1 kg and a minimum of clothes in the morning, height, waist and hip circumference using a tape measure with an accuracy of 0.1 cm, and Bio Mass Index and waist-hip ratio was calculated.;Body composition. Timepoint: 2 Times during the study: at the beginning and end of each intervention month. Method of measurement: Measurement of body composition, including fat mass, fat free mass and total body water determination using Bioelectric Impedance Analyzer ( BIA).;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.
- Secondary Outcome Measures
Name Time Method Fasting srum lipid profile (Low Density Lipoprotein,High Density Lipoprotein,total cholesterol,Three Glycerid). Timepoint: Before and after intervention. Method of measurement: Enzymatic method for total cholesterol, triglyceride and High Density Lipoprotein and Freidwald’s formula forLow Density Lipoprotein.c.;Hepatic Enzyms. Timepoint: Before and after intervention. Method of measurement: kits.;Dertemining of Uric acid, Cratinin, Bilirubin. Timepoint: Before and after intervention. Method of measurement: kits.;Serum inflammatory values (Inter lukine-6, Tumor necrosis factors-a, High-sensitivity C-reactive Protein). Timepoint: Before and after intervention. Method of measurement: High-sensitivity C-reactive Protein assess with Immunotorbidometric method and Inter lukine-6, Tumor necrosis factors-a with Eliza method.;Serum levels of leptin, Grelin. Timepoint: Befor and after intervention. Method of measurement: By Laboratory ELISA Kits.