Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD
- Conditions
- Weight LossDNA DamageObesity
- Registration Number
- NCT05055154
- Lead Sponsor
- Special Hospital for Extended Treatment of Duga Resa
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- body mass index ≥ 35 kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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)
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 inflammation parameters Baseline, after 3 weeks of VLCD Concentration of C-reactive protein (mg/L) and total white blood cell count
- Secondary Outcome Measures
Name Time Method The changes in oxidative stress Baseline, after 3 weeks of VLCD Concentration of glutathione (RFU) and reactive oxygen species (RFU)
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
Trial Locations
- Locations (1)
Special Hospital for Extended Treatment of Duga Resa
🇭🇷Duga Resa, Croatia
Special Hospital for Extended Treatment of Duga Resa🇭🇷Duga Resa, Croatia