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

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

NCT05007171

DNAa3WVLCDiBMI-35/22

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 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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22 participants in 1 patient group

Very low calorie diet

Experimental group

Description:

Use of very low calorie diet in hospital for 3 weeks

Treatment:

Device: Very low calorie diet