Obesity, Weight Loss, DNA Damage
Conditions
Keywords
Obesity, Very low calorie diet, Oxidative stress, Micronuclei, apoptosis
Brief summary
Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.
Detailed description
Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric parameters.
Interventions
DEVICEVery low calorie diet
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks
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) and total white blood cell count |
| The changes in insulin concentration | Baseline, after 3 weeks of VLCD | Concentration of insulin (mIU/L) |
| The changes in homeostatic model assessment (HOMA) index | Baseline, after 3 weeks of VLCD | HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5 |
| The changes in body mass index | Baseline, after 3 weeks of VLCD | Body mass index is calculated by dividing body mass (kg) with square of 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 lipid profile | Baseline, after 3 weeks of VLCD | Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes in DNA damage | Baseline, after 3 weeks of VLCD | Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes |
| The changes in oxidative stress | Baseline, after 3 weeks of VLCD | Concentration of glutathione (RFU) and reactive oxygen species (RFU) |
Countries
Croatia
Outcome results
None listed