Skip to main content
OpenTrials
Completed

NCT Number: NCT05007171

Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients

Obesity manifest with inflammation, hyperglycaemia and dyslipidaemia. These conditions disturb redox system by generating excessive reactive oxygen species (ROS) and causing oxidative stress (OS) leading to DNA damage. Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis, inflammation and OS. The aim of study is to test the influence of 3-weeks VLCD on anthropometric, biochemical and genomic parameters in class II and III obesity patients.

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, City of Zagreb, 47250, Croatia

About this study

Obesity is a chronic disease associated with chronic inflammation, insulin resistance, dyslipidemia, oxidative stress and increased risk for type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress can lead to base lesions of DNA which could be detected with alkine comet assay and its version with use of formamidopyrimidine DNA glycosylase-endonuclease enzyme in fresh or frozen small volume samples. Dietary caloric restriction has beneficial effects on insulin sensitivity, inflammation, oxidative stress and DNA repair. Very low calorie diet (VLCD) data are scarce, especially on the changing levels of DNA damage.This study will assess the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in individuals with BMI ≥ 35kg/m2 on the level of primary and oxidative DNA damage as well as body composition and biochemical 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

During 3 weeks in hospital patients will eat prepared very low calorie diet composed of 50-60% complex carbohydrates with low carbo-glycemic index, 20-25% proteins and 25-30% fat

Primary outcomes

  1. The changes in the body mass index

    Time frame: Baseline, after 3 weeks of VLCD

    Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured 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 insulin concentration

    Time frame: Baseline, after 3 weeks of VLCD

    Concentration of insulin (mIU/L)

  8. The changes in HOMA index

    Time frame: Baseline, after 3 weeks of VLCD

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

  9. 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)

  10. The changes in inflammation parameters

    Time frame: Baseline, after 3 weeks of VLCD

    Concentration of C-reactive protein (mg/L)

  11. The changes in inflammation parameters

    Time frame: Baseline, after 3 weeks of VLCD

    Concentration of total white blood cell count

Secondary outcomes

  1. The changes in DNA damage assessed with alkaline comet assay

    Time frame: Baseline, after 3 weeks of VLCD

    Values for alkaline comet assay in μm for tale length

  2. The changes in DNA damage assessed with alkaline comet assay

    Time frame: Baseline, after 3 weeks of VLCD

    Values for alkaline comet assay in % for tale intensity

  3. The changes in oxidative DNA damage assessed with FPG comet assay

    Time frame: Baseline, after 3 weeks of VLCD

    Values for FPG comet assay in % for tale intensity

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

Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks-567-kcal VLCD in Severely Obese Patients With BMI ≥ 35kg/m2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2021
Registry last updated
Aug 16, 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.