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

Not Applicable

Completed

• Conditions: Obesity; Weight Loss; DNA Damage
• Interventions: Device: Very low calorie diet

• Registration Number: NCT05007171
• Lead Sponsor: Special Hospital for Extended Treatment of Duga Resa

Brief 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.

Study Timeline

• Study Start: 2019-06-14
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Study First Submitted: 2021-07-16
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Very low calorie diet	Very low calorie diet	Use of very low calorie diet in hospital for 3 weeks

Primary Outcome Measures

Name	Time	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 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 the body mass index	Baseline, after 3 weeks of VLCD	Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured body height (m)
The changes in fasting glucose concentration	Baseline, after 3 weeks of VLCD	Concentration of glucose (mmol/L)
The changes in inflammation parameters	Baseline, after 3 weeks of VLCD	Concentration of total white blood cell count
The changes in insulin concentration	Baseline, after 3 weeks of VLCD	Concentration of insulin (mIU/L)
The changes in urea concentration	Baseline, after 3 weeks of VLCD	Concentration of urea (mmol/L)
The changes in HOMA index	Baseline, after 3 weeks of VLCD	HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5
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 percent body fat	Baseline, after 3 weeks of VLCD	Percent body fat (%) assessed with bioelectrical impedance method

Secondary Outcome Measures

Name	Time	Method
The changes in DNA damage assessed with alkaline comet assay	Baseline, after 3 weeks of VLCD	Values for alkaline comet assay in % for tale intensity
The changes in oxidative DNA damage assessed with FPG comet assay	Baseline, after 3 weeks of VLCD	Values for FPG comet assay in % for tale intensity

Trial Locations

Locations (1)

Special Hospital for Extended Treatment of Duga Resa; 🇭🇷 Duga Resa, City Of Zagreb, Croatia