Clinical trial NCT05055154: Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD
Official title: Oxidative Stress and L-CBMN Cytome Assay Parameters Levels in Severely Obese With BMI ≥ 35kg/m2 After 3 Weeks 567 kcal Hospital Controlled VLCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
DNA Damage
Keywords: Obesity
Very low calorie diet
Oxidative stress
Micronuclei
apoptosis
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: 2021-09-24
Enrollment: 26
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 leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and inflammation and can generate systematic oxidative stress through multiple biochemical mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, insulin resistance, inflammation and OS. The aim of this study is to determine the effect of a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with BMI ≥ 35kg/m2.

Detailed description: Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric 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 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 lipid profile
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in insulin concentration
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in homeostatic model assessment (HOMA) index
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 oxidative stress
timeFrame: Baseline, after 3 weeks of VLCD
measure: The changes in DNA damage
timeFrame: Baseline, after 3 weeks of VLCD
Other outcomes:
Locations:
city: Duga Resa
country: Croatia
facility: Special Hospital for Extended Treatment of Duga Resa
Study officials:
affiliation: Institute for Medical Research and Occupational Health
name: Mirta Milic, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Special Hospital for Extended Treatment of Duga Resa
name: Dragan Bozcevic, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zagreb
name: Ana-Marija Domijan, Prof.
role: PRINCIPAL_INVESTIGATOR
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