obesity. Obesity due to excess calories
Conditions
Interventions
Intervention 1: Intervention group: melatonin which is a natural hormone in the body and regulates sleep will be administered as oral supplement at a dose of 6 milligram (2 melatonin tablet, 3 mg ea
made by Nature Made, USA) 2 hours before bed time for 40 days with weight loss diet. Intervention 2: Control group will receive 6 mg placebo ( 2 tablet, 3 mg each containing cellulose, silicon dioxi
Treatment - Drugs
Placebo
Intervention group: melatonin which is a natural hormone in the body and regulates sleep will be administered as oral supplement at a dose of 6 milligram (2 melatonin tablet, 3 mg each
made by Nature Made, USA) 2 hours before bed time for 40 days with weight loss diet.
Control group will receive 6 mg placebo ( 2 tablet, 3 mg each containing cellulose, silicon dioxide and starch) 2 hours before bed time for 40 days with weight loss diet.
Sponsors
Vice-Chancellor for Research, Tabriz University of Medical Sciences- Nutrition Research Center
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Volunteer women with body mass index(BMI) =30 or more, aged between 20-50 years with maintained weight during the last six months Exclusion criteria: Include pregnancy and lactation, menopause, smoking, alcohol consumption, having endocrine or kidney disease, depression, taking tranquilizers, contraceptives, anti- inflammatory, glucose and lipid- lowering drugs. Also taking any kind of antioxidant supplements in the last 3 months
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adiponectin. Timepoint: The onset and end of the study. Method of measurement: ELISA.;Glucose. Timepoint: The onset and end of the study. Method of measurement: Enzymatic colorimetric.;Insulin. Timepoint: The onset and end of the study. Method of measurement: Chemiluminescence.;High sensitive c- reactive protein. Timepoint: the onset and end of the study. Method of measurement: immunoturbidometry.;Leptin. Timepoint: The onset and end of the study. Method of measurement: ELISA.;Nutritional status. Timepoint: The onset and end of the study. Method of measurement: Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer.;Total antioxidant capacity. Timepoint: The onset and end of the study. Method of measurement: Spectrophotometry.;LDL-C. Timepoint: The onset and end of the study. Method of measurement: Enzymatic colorimetric.;Total cholesterol. Timepoint: The onset and end of the study. Method of measurement: Enzymatic colorimetric.;Malondialdehyde. Timepoint: The onset and end of the study. Method of measurement: Spectrophotometry.;HDL-C. Timepoint: The onset and end of the study. Method of measurement: Enzymatic colorimetric.;Triglyceride. Timepoint: The onset and end of the study. Method of measurement: Enzymatic colorimetric. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Alireza Ostadrahimi
Faculty of Health and Nutrition, Tabriz University Of Medical Sciences
Outcome results
None listed