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

Special Hospital for Extended Treatment of Duga Resa

Status: Completed

Conditions: Weight Loss; Obesity; DNA Damage

Treatments: Device: Very low calorie diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05055154

OSMN35aVLCD-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Very low calorie diet

Experimental group

Description:

Use of very low calorie diet prepared in the hospital

Treatment:

Device: Very low calorie diet