None listed
Conditions
Interventions
Intervention1: melatonin, calorie-restricted diet: 1 arm 10 mg OD 1 hr before bedtime for 30 days, diet: 1000â??1200 kcal/day for women and 1400â??1600 kcal/day for men
Control Intervention1: placebo,
Sponsors
Karolina Szewczyk Golec
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. changes in body weight (kilograms), body mass index, waist and hip circumferences 2. changes in the oxidative stress parameters measured using biochemical analysis (Elisa/Essay techniques) 3. glycaemic, lipaemic, and inflammatory responses measured using biochemical analysis (Elisa/Essay techniques) 4. modifications in the plasma adipokine levels measured using Elisa techniques Timepoint: at baseline and 30 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| effect of a calorie-restricted diet on the plasma melatonin morning levels measured using Elisa techniqueTimepoint: 30 days | — |
Countries
Poland
Contacts
Public ContactKarolina Szewczyk Golec
L. Rydygier Medical College in Bydgoszcz Nicolaus Copernicus University in Torun, Poland
Outcome results
None listed