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

Primary Purpose

Obesity, Weight Loss, DNA Damage

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Very low calorie diet
Sponsored by
Special Hospital for Extended Treatment of Duga Resa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Very low calorie diet, Oxidative stress, Micronuclei, apoptosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Special Hospital for Extended Treatment of Duga Resa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Very low calorie diet

Arm Description

Use of very low calorie diet prepared in the hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The changes in oxidative stress
Concentration of glutathione (RFU) and reactive oxygen species (RFU)
The changes in DNA damage
Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes

Full Information

First Posted
September 14, 2021
Last Updated
September 14, 2021
Sponsor
Special Hospital for Extended Treatment of Duga Resa
Collaborators
Institute for Medical Research and Occupational Health, University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT05055154
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Special Hospital for Extended Treatment of Duga Resa
Collaborators
Institute for Medical Research and Occupational Health, University of Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss, DNA Damage
Keywords
Obesity, Very low calorie diet, Oxidative stress, Micronuclei, apoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Very low calorie diet
Arm Type
Experimental
Arm Description
Use of very low calorie diet prepared in the hospital
Intervention Type
Device
Intervention Name(s)
Very low calorie diet
Intervention Description
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks
Primary Outcome Measure Information:
Title
The changes in body mass index
Description
Body mass index is calculated by dividing body mass (kg) with square of body height (m)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in the body fat mass
Description
Body fat mass (kg) assessed with bioelectrical impedance method
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in the skeletal muscle mass
Description
Skeletal muscle mass (kg) assessed with bioelectrical impedance method
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in the percent body fat
Description
Percent body fat (%) assessed with bioelectrical impedance method
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in fasting glucose concentration
Description
Concentration of glucose (mmol/L)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in urea concentration
Description
Concentration of urea (mmol/L)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in lipid profile
Description
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in insulin concentration
Description
Concentration of insulin (mIU/L)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in homeostatic model assessment (HOMA) index
Description
HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in inflammation parameters
Description
Concentration of C-reactive protein (mg/L) and total white blood cell count
Time Frame
Baseline, after 3 weeks of VLCD
Secondary Outcome Measure Information:
Title
The changes in oxidative stress
Description
Concentration of glutathione (RFU) and reactive oxygen species (RFU)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in DNA damage
Description
Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes
Time Frame
Baseline, after 3 weeks of VLCD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirta Milic, PhD
Organizational Affiliation
Institute for Medical Research and Occupational Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dragan Bozcevic, Doctor
Organizational Affiliation
Special Hospital for Extended Treatment of Duga Resa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana-Marija Domijan, Prof.
Organizational Affiliation
University of Zagreb
Official's Role
Principal Investigator
Facility Information:
Facility Name
Special Hospital for Extended Treatment of Duga Resa
City
Duga Resa
ZIP/Postal Code
47250
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
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Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD

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