Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oxidative Stress and L-CBMN Cytome Assay Parameters Levels in Severely Obese With BMI ≥ 35kg/m2 After 3 Weeks 567 kcal Hospital Controlled VLCD

Conditions
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Obesity, Weight Loss, DNA Damage

Intervention / Treatment
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* Device: Very low calorie diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very low calorie diet<br>Use of very low calorie diet prepared in the hospital | Device: Very low calorie diet<br>* In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in body mass index | Body mass index is calculated by dividing body mass (kg) with square of body height (m) | Baseline, after 3 weeks of VLCD | 
| The changes in the body fat mass | Body fat mass (kg) assessed with bioelectrical impedance method | Baseline, after 3 weeks of VLCD | 
| The changes in the skeletal muscle mass | Skeletal muscle mass (kg) assessed with bioelectrical impedance method | Baseline, after 3 weeks of VLCD | 
| The changes in the percent body fat | Percent body fat (%) assessed with bioelectrical impedance method | Baseline, after 3 weeks of VLCD | 
| The changes in fasting glucose concentration | Concentration of glucose (mmol/L) | Baseline, after 3 weeks of VLCD | 
| The changes in urea concentration | Concentration of urea (mmol/L) | Baseline, after 3 weeks of VLCD | 
| The changes in lipid profile | Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L) | Baseline, after 3 weeks of VLCD | 
| The changes in insulin concentration | Concentration of insulin (mIU/L) | Baseline, after 3 weeks of VLCD | 
| The changes in homeostatic model assessment (HOMA) index | HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5 | Baseline, after 3 weeks of VLCD | 
| The changes in inflammation parameters | Concentration of C-reactive protein (mg/L) and total white blood cell count | Baseline, after 3 weeks of VLCD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in oxidative stress | Concentration of glutathione (RFU) and reactive oxygen species (RFU) | Baseline, after 3 weeks of VLCD | 
| The changes in DNA damage | Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes | Baseline, after 3 weeks of VLCD | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Very low calorie diet, Oxidative stress, Micronuclei, apoptosis