Clinical trial NCT05007171: Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients
Official title: Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks-567-kcal VLCD in Severely Obese Patients With BMI ≥ 35kg/m2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
DNA Damage
Keywords: Obesity
Very low calorie diet
Alkine comet assay
FPG oxidative comet assay
DNA damage
Lead sponsor: Special Hospital for Extended Treatment of Duga Resa
Sponsor class: OTHER_GOV
Collaborators: name: Institute for Medical Research and Occupational Health
name: University of Zagreb
First posted: 2021-08-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The changes in the body mass index
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in the body fat mass
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in the skeletal muscle mass
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in the percent body fat
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in fasting glucose concentration
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in urea concentration
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in insulin concentration
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in HOMA index
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in lipid profile
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in inflammation parameters
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in inflammation parameters
timeFrame: Baseline, after 3 weeks of VLCD
Secondary outcomes:
measure: The changes in DNA damage assessed with alkaline comet assay
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in DNA damage assessed with alkaline comet assay
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in oxidative DNA damage assessed with FPG comet assay
timeFrame: Baseline, after 3 weeks of VLCD
Other outcomes:
Locations:
city: Duga Resa
country: Croatia
facility: Special Hospital for Extended Treatment of Duga Resa
state: City Of Zagreb
Study officials:
affiliation: Institute for Medical Research and Occupational Health
name: Mirta Milic, PhD
role: PRINCIPAL_INVESTIGATOR
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