NCT05007171

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (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 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

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.

Conditions

• Obesity
• Weight Loss
• DNA Damage

Interventions

Type	Name	Description
DEVICE	Very low calorie diet	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

Timeline

• Start date: 2019-06-14
• Primary completion: 2020-03-09
• Completion: 2020-03-09
• First posted: 2021-08-16
• Last updated: 2021-08-16

Locations

1 site across 1 country: Croatia