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

Sponsor

Special Hospital for Extended Treatment of Duga Resa (Other)

Overall Status

Completed

CT.gov ID

NCT05007171

Collaborator

Institute for Medical Research and Occupational Health (Other), University of Zagreb (Other)

Enrollment

Location

Arm

8.8

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Weight Loss DNA Damage	Device: Very low calorie diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 14, 2019

Actual Primary Completion Date :

Mar 9, 2020

Actual Study Completion Date :

Mar 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Very low calorie diet Use of very low calorie diet in hospital for 3 weeks	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

Arm

Intervention/Treatment

Experimental: Very low calorie diet

Use of very low calorie diet in hospital for 3 weeks

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

Outcome Measures

Primary Outcome Measures

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 the body fat mass [Baseline, after 3 weeks of VLCD]
Body fat mass (kg) assessed with bioelectrical impedance 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 the percent body fat [Baseline, after 3 weeks of VLCD]
Percent body fat (%) assessed with bioelectrical impedance method
The changes in fasting glucose concentration [Baseline, after 3 weeks of VLCD]
Concentration of glucose (mmol/L)
The changes in urea concentration [Baseline, after 3 weeks of VLCD]
Concentration of urea (mmol/L)
The changes in insulin concentration [Baseline, after 3 weeks of VLCD]
Concentration of insulin (mIU/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 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 inflammation parameters [Baseline, after 3 weeks of VLCD]
Concentration of C-reactive protein (mg/L)
The changes in inflammation parameters [Baseline, after 3 weeks of VLCD]
Concentration of total white blood cell count

Secondary Outcome Measures

The changes in DNA damage assessed with alkaline comet assay [Baseline, after 3 weeks of VLCD]
Values for alkaline comet assay in μm for tale length
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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