NCT05055154

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Special Hospital for Extended Treatment of Duga Resa · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Weight Loss
• DNA Damage

Interventions

Type	Name	Description
DEVICE	Very low calorie diet	In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks

Timeline

• Start date: 2019-06-14
• Primary completion: 2020-11-03
• Completion: 2020-11-03
• First posted: 2021-09-24
• Last updated: 2021-09-24

Locations

1 site across 1 country: Croatia