Obesity, Weight Loss, DNA Damage
Conditions
Keywords
Obesity, Very low calorie diet, Alkine comet assay, FPG oxidative comet assay, DNA damage
Brief summary
Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class II and III obesity patients.
Detailed description
Obesity is a chronic disease associated with chronic inflammation, insulin resistance, dyslipidemia, oxidative stress and increased risk for type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress can lead to base lesions of DNA which could be detected with alkine comet assay and its version with use of formamidopyrimidine DNA glycosylase-endonuclease enzyme in fresh or frozen small volume samples. Dietary caloric restriction has beneficial effects on insulin sensitivity, inflammation, oxidative stress and DNA repair. Very low calorie diet (VLCD) data are scarce, especially on the changing levels of DNA damage.This study will assess the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in individuals with BMI ≥ 35kg/m2 on the level of primary and oxidative DNA damage as well as body composition and biochemical parameters.
Interventions
DEVICEVery low calorie diet
During 3 weeks in hospital patients will eat prepared very low calorie diet composed of 50-60% complex carbohydrates with low carbo-glycemic index, 20-25% proteins and 25-30% fat
Sponsors
Institute for Medical Research and Occupational Health
University of Zagreb
Special Hospital for Extended Treatment of Duga Resa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* body mass index ≥ 35 kg/m2
Exclusion criteria
* pregnancy * actual tumor diseases * recent diagnostic or treatment exposures to ionizing radiation in the period of one year * individuals not willing to stay 3 weeks under supervision under full 24 h surveillance from the medical stuff
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes in inflammation parameters | Baseline, after 3 weeks of VLCD | Concentration of C-reactive protein (mg/L) |
| The changes in HOMA index | Baseline, after 3 weeks of VLCD | HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5 |
| The changes in lipid profile | Baseline, after 3 weeks of VLCD | Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L) |
| The changes in the body mass index | Baseline, after 3 weeks of VLCD | Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured body height (m) |
| The changes in the body fat mass | Baseline, after 3 weeks of VLCD | Body fat mass (kg) assessed with bioelectrical impedance method |
| The changes in the skeletal muscle mass | Baseline, after 3 weeks of VLCD | Skeletal muscle mass (kg) assessed with bioelectrical impedance method |
| The changes in the percent body fat | Baseline, after 3 weeks of VLCD | Percent body fat (%) assessed with bioelectrical impedance method |
| The changes in fasting glucose concentration | Baseline, after 3 weeks of VLCD | Concentration of glucose (mmol/L) |
| The changes in urea concentration | Baseline, after 3 weeks of VLCD | Concentration of urea (mmol/L) |
| The changes in insulin concentration | Baseline, after 3 weeks of VLCD | Concentration of insulin (mIU/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in oxidative DNA damage assessed with FPG comet assay | Baseline, after 3 weeks of VLCD | Values for FPG comet assay in % for tale intensity |
| The changes in DNA damage assessed with alkaline comet assay | Baseline, after 3 weeks of VLCD | Values for alkaline comet assay in μm for tale length |
Countries
Croatia
Outcome results
None listed