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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Special Hospital for Extended Treatment of Duga Resa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute for Medical Research and Occupational Health
University of Zagreb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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