Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks-567-kcal VLCD in Severely Obese Patients With BMI ≥ 35kg/m2

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 in hospital for 3 weeks | Device: Very low calorie diet<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in the body mass index | Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured 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 insulin concentration | Concentration of insulin (mIU/L) | Baseline, after 3 weeks of VLCD | 
| The changes in HOMA index | HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5 | 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 inflammation parameters | Concentration of C-reactive protein (mg/L) | Baseline, after 3 weeks of VLCD | 
| The changes in inflammation parameters | Concentration of total white blood cell count | Baseline, after 3 weeks of VLCD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in DNA damage assessed with alkaline comet assay | Values for alkaline comet assay in μm for tale length | Baseline, after 3 weeks of VLCD | 
| The changes in DNA damage assessed with alkaline comet assay | Values for alkaline comet assay in % for tale intensity | Baseline, after 3 weeks of VLCD | 
| The changes in oxidative DNA damage assessed with FPG comet assay | Values for FPG comet assay in % for tale intensity | 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, Alkine comet assay, FPG oxidative comet assay, DNA damage