Skip to main content
OpenTrials
Completed

NCT Number: NCT05055154

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Body Weight Changes DNA Damage Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Special Hospital for Extended Treatment of Duga Resa

Duga Resa, 47250, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very low calorie diet

Device

In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks

Primary outcomes

  1. 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)

  2. The changes in the body fat mass

    Time frame: Baseline, after 3 weeks of VLCD

    Body fat mass (kg) assessed with bioelectrical impedance method

  3. The changes in the skeletal muscle mass

    Time frame: Baseline, after 3 weeks of VLCD

    Skeletal muscle mass (kg) assessed with bioelectrical impedance method

  4. The changes in the percent body fat

    Time frame: Baseline, after 3 weeks of VLCD

    Percent body fat (%) assessed with bioelectrical impedance method

  5. The changes in fasting glucose concentration

    Time frame: Baseline, after 3 weeks of VLCD

    Concentration of glucose (mmol/L)

  6. The changes in urea concentration

    Time frame: Baseline, after 3 weeks of VLCD

    Concentration of urea (mmol/L)

  7. 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)

  8. The changes in insulin concentration

    Time frame: Baseline, after 3 weeks of VLCD

    Concentration of insulin (mIU/L)

  9. 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

  10. 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

Secondary outcomes

  1. The changes in oxidative stress

    Time frame: Baseline, after 3 weeks of VLCD

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

  2. 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

Sponsors and collaborators

Lead sponsor

Special Hospital for Extended Treatment of Duga Resa

Other Gov

Collaborators

  • Institute for Medical Research and Occupational Health
  • University of Zagreb

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2021
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.