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

August 10, 2021 updated by: Special Hospital for Extended Treatment of Duga Resa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • 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
    • City Of Zagreb
      • Duga Resa, City Of Zagreb, 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Very low calorie diet
Use of very low calorie diet in hospital for 3 weeks
Device: Very low calorie diet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, after 3 weeks of VLCD
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 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
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 inflammation parameters
Time Frame: Baseline, after 3 weeks of VLCD
Concentration of C-reactive protein (mg/L)
Baseline, after 3 weeks of VLCD
The changes in inflammation parameters
Time Frame: Baseline, after 3 weeks of VLCD
Concentration of total white blood cell count
Baseline, after 3 weeks of VLCD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, after 3 weeks of VLCD
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
Baseline, after 3 weeks of VLCD
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
Baseline, after 3 weeks of VLCD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Special Hospital for Extended Treatment of Duga Resa

Collaborators

Institute for Medical Research and Occupational Health
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)

June 14, 2019

Primary Completion (Actual)

March 9, 2020

Study Completion (Actual)

March 9, 2020

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNAa3WVLCDiBMI-35/22

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Obesity

Clinical Trials on Very low calorie diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe