Effect of supplementation with melatonin (a hormone secreted by the gland in the human body that regulates the sleep cycle) in obese patients on a diet with reduced caloric intake
Not Applicable
- Registration Number
- CTRI/2017/07/009093
- Lead Sponsor
- Karolina Szewczyk Golec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
obesity due to excess calories (E66.0) according to the International Classification of Diseases, 10th Revision
Body Mass Index (BMI) equal to or greater than 30 kg/m2
signed written informed consent
healthy as determined by medical history and laboratory examination performed one day before admission day
Exclusion Criteria
metabolic syndrome according to the WHO criteria
addiction to alcohol and/or tobacco
diabetes mellitus
primary hypertension
ischemic heart disease
history of stroke
renal failure
cancer
other conditions of known free radical etiology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. changes in body weight (kilograms), body mass index, waist and hip circumferences <br/ ><br>2. changes in the oxidative stress parameters measured using biochemical analysis (Elisa/Essay techniques) <br/ ><br>3. glycaemic, lipaemic, and inflammatory responses measured using biochemical analysis (Elisa/Essay techniques) <br/ ><br>4. modifications in the plasma adipokine levels measured using Elisa techniques <br/ ><br>Timepoint: at baseline and 30 days of treatment
- Secondary Outcome Measures
Name Time Method effect of a calorie-restricted diet on the plasma melatonin morning levels measured using Elisa techniqueTimepoint: 30 days