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

Sponsor
Special Hospital for Extended Treatment of Duga Resa (Other)
Overall Status
Completed
CT.gov ID
NCT05055154
Collaborator
Institute for Medical Research and Occupational Health (Other), University of Zagreb (Other)
26
1
1
16.7
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Very low calorie diet
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 14, 2019
Actual Primary Completion Date :
Nov 3, 2020
Actual Study Completion Date :
Nov 3, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The changes in body mass index [Baseline, after 3 weeks of VLCD]

    Body mass index is calculated by dividing body mass (kg) with square of body height (m)

  2. The changes in the body fat mass [Baseline, after 3 weeks of VLCD]

    Body fat mass (kg) assessed with bioelectrical impedance method

  3. The changes in the skeletal muscle mass [Baseline, after 3 weeks of VLCD]

    Skeletal muscle mass (kg) assessed with bioelectrical impedance method

  4. The changes in the percent body fat [Baseline, after 3 weeks of VLCD]

    Percent body fat (%) assessed with bioelectrical impedance method

  5. The changes in fasting glucose concentration [Baseline, after 3 weeks of VLCD]

    Concentration of glucose (mmol/L)

  6. The changes in urea concentration [Baseline, after 3 weeks of VLCD]

    Concentration of urea (mmol/L)

  7. The changes in lipid profile [Baseline, after 3 weeks of VLCD]

    Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)

  8. The changes in insulin concentration [Baseline, after 3 weeks of VLCD]

    Concentration of insulin (mIU/L)

  9. The changes in homeostatic model assessment (HOMA) index [Baseline, after 3 weeks of VLCD]

    HOMA index is calculated according to the following formula: glucose (mmol/L) x insulin (mIU/L)/22.5

  10. The changes in inflammation parameters [Baseline, after 3 weeks of VLCD]

    Concentration of C-reactive protein (mg/L) and total white blood cell count

Secondary Outcome Measures

  1. The changes in oxidative stress [Baseline, after 3 weeks of VLCD]

    Concentration of glutathione (RFU) and reactive oxygen species (RFU)

  2. The changes in DNA damage [Baseline, after 3 weeks of VLCD]

    Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Special Hospital for Extended Treatment of Duga Resa Duga Resa Croatia 47250

Sponsors and Collaborators

  • Special Hospital for Extended Treatment of Duga Resa
  • Institute for Medical Research and Occupational Health
  • University of Zagreb

Investigators

  • Principal Investigator: Mirta Milic, PhD, Institute for Medical Research and Occupational Health
  • Principal Investigator: Dragan Bozcevic, Doctor, Special Hospital for Extended Treatment of Duga Resa
  • Principal Investigator: Ana-Marija Domijan, Prof., University of Zagreb

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Special Hospital for Extended Treatment of Duga Resa
ClinicalTrials.gov Identifier:
NCT05055154
Other Study ID Numbers:
  • OSMN35aVLCD-26
First Posted:
Sep 24, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Special Hospital for Extended Treatment of Duga Resa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021