Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD

September 14, 2021 updated by: Special Hospital for Extended Treatment of Duga Resa

Oxidative Stress and L-CBMN Cytome Assay Parameters Levels in Severely Obese With BMI ≥ 35kg/m2 After 3 Weeks 567 kcal Hospital Controlled VLCD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Duga Resa, Croatia, 47250
        • Special Hospital for Extended Treatment of Duga Resa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Very low calorie diet
Use of very low calorie diet prepared in the hospital
Device: Very low calorie diet
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in the body fat mass
Time Frame: Baseline, after 3 weeks of VLCD
Body fat mass (kg) assessed with bioelectrical impedance method
Baseline, after 3 weeks of VLCD
The changes in the skeletal muscle mass
Time Frame: Baseline, after 3 weeks of VLCD
Skeletal muscle mass (kg) assessed with bioelectrical impedance method
Baseline, after 3 weeks of VLCD
The changes in the percent body fat
Time Frame: Baseline, after 3 weeks of VLCD
Percent body fat (%) assessed with bioelectrical impedance method
Baseline, after 3 weeks of VLCD
The changes in fasting glucose concentration
Time Frame: Baseline, after 3 weeks of VLCD
Concentration of glucose (mmol/L)
Baseline, after 3 weeks of VLCD
The changes in urea concentration
Time Frame: Baseline, after 3 weeks of VLCD
Concentration of urea (mmol/L)
Baseline, after 3 weeks of VLCD
The changes in insulin concentration
Time Frame: Baseline, after 3 weeks of VLCD
Concentration of insulin (mIU/L)
Baseline, after 3 weeks of VLCD
The changes in lipid profile
Time Frame: Baseline, after 3 weeks of VLCD
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
Baseline, after 3 weeks of VLCD
The changes in body mass index
Time Frame: Baseline, after 3 weeks of VLCD
Body mass index is calculated by dividing body mass (kg) with square of body height (m)
Baseline, after 3 weeks of VLCD
The changes in homeostatic model assessment (HOMA) index
Time Frame: Baseline, after 3 weeks of VLCD
HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5
Baseline, after 3 weeks of VLCD
The changes in inflammation parameters
Time Frame: Baseline, after 3 weeks of VLCD
Concentration of C-reactive protein (mg/L) and total white blood cell count
Baseline, after 3 weeks of VLCD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in oxidative stress
Time Frame: Baseline, after 3 weeks of VLCD
Concentration of glutathione (RFU) and reactive oxygen species (RFU)
Baseline, after 3 weeks of VLCD
The changes in DNA damage
Time Frame: Baseline, after 3 weeks of VLCD
Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes
Baseline, after 3 weeks of VLCD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Special Hospital for Extended Treatment of Duga Resa

Collaborators

Institute for Medical Research and Occupational Health
University of Zagreb

Investigators

  • Principal Investigator: Dragan Bozcevic, Doctor, Special Hospital for Extended Treatment of Duga Resa
  • Principal Investigator: Ana-Marija Domijan, Prof., University of Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 2019

Primary Completion (ACTUAL)

November 3, 2020

Study Completion (ACTUAL)

November 3, 2020

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (ACTUAL)

September 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSMN35aVLCD-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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