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

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, Alkine comet assay, FPG oxidative comet assay, DNA damage

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 in hospital for 3 weeks

Outcomes

Primary Outcome Measures

The changes in the body mass index
Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured 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 insulin concentration
Concentration of insulin (mIU/L)
The changes in HOMA index
HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5
The changes in lipid profile
Concentrations of triglycerides (mmo/L), LDL (mmol/L), HDL (mmol/L) cholesterol (mmol/L)
The changes in inflammation parameters
Concentration of C-reactive protein (mg/L)
The changes in inflammation parameters
Concentration of total white blood cell count

Secondary Outcome Measures

The changes in DNA damage assessed with alkaline comet assay
Values for alkaline comet assay in μm for tale length
The changes in DNA damage assessed with alkaline comet assay
Values for alkaline comet assay in % for tale intensity
The changes in oxidative DNA damage assessed with FPG comet assay
Values for FPG comet assay in % for tale intensity

Full Information

First Posted
July 16, 2021
Last Updated
August 10, 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
NCT05007171
Brief Title
Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients
Official Title
Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks-567-kcal VLCD in Severely Obese Patients With BMI ≥ 35kg/m2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 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 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.
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.

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, Alkine comet assay, FPG oxidative comet assay, DNA damage

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Very low calorie diet
Arm Type
Experimental
Arm Description
Use of very low calorie diet in hospital for 3 weeks
Intervention Type
Device
Intervention Name(s)
Very low calorie diet
Intervention Description
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 Outcome Measure Information:
Title
The changes in the body mass index
Description
Body mass index (kg/m2) is calculated by using measured body weight (kg) with measured 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 insulin concentration
Description
Concentration of insulin (mIU/L)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in HOMA index
Description
HOMA index is calculated according to the formula: glucose (mmol/L) x insulin (mIU/L)/22.5
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 inflammation parameters
Description
Concentration of C-reactive protein (mg/L)
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in inflammation parameters
Description
Concentration of total white blood cell count
Time Frame
Baseline, after 3 weeks of VLCD
Secondary Outcome Measure Information:
Title
The changes in DNA damage assessed with alkaline comet assay
Description
Values for alkaline comet assay in μm for tale length
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in DNA damage assessed with alkaline comet assay
Description
Values for alkaline comet assay in % for tale intensity
Time Frame
Baseline, after 3 weeks of VLCD
Title
The changes in oxidative DNA damage assessed with FPG comet assay
Description
Values for FPG comet assay in % for tale intensity
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
Facility Information:
Facility Name
Special Hospital for Extended Treatment of Duga Resa
City
Duga Resa
State/Province
City Of Zagreb
ZIP/Postal Code
47250
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients

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