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

NCT05055154 | Completed

• 1 other identifier: OSMN35aVLCD-26
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Weight Loss; DNA Damage

Keywords

Obesity; Very low calorie diet; Oxidative stress; Micronuclei; apoptosis

Outcome Measures

Primary Outcomes (10)

• The changes in body mass index

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

  Baseline, after 3 weeks of VLCD

• The changes in the body fat mass

  Body fat mass (kg) assessed with bioelectrical impedance method

  Baseline, after 3 weeks of VLCD

• The changes in the skeletal muscle mass

  Skeletal muscle mass (kg) assessed with bioelectrical impedance method

  Baseline, after 3 weeks of VLCD

• The changes in the percent body fat

  Percent body fat (%) assessed with bioelectrical impedance method

  Baseline, after 3 weeks of VLCD

• The changes in fasting glucose concentration

  Concentration of glucose (mmol/L)

  Baseline, after 3 weeks of VLCD

• The changes in urea concentration

  Concentration of urea (mmol/L)

  Baseline, after 3 weeks of VLCD

• The changes in lipid profile

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

  Baseline, after 3 weeks of VLCD

• The changes in insulin concentration

  Concentration of insulin (mIU/L)

  Baseline, after 3 weeks of VLCD

• The changes in homeostatic model assessment (HOMA) index

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

  Baseline, after 3 weeks of VLCD

• The changes in inflammation parameters

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

  Baseline, after 3 weeks of VLCD

Secondary Outcomes (2)

• The changes in oxidative stress

  Baseline, after 3 weeks of VLCD

• The changes in DNA damage

  Baseline, after 3 weeks of VLCD

Study Arms (1)

Very low calorie diet

EXPERIMENTAL

Use of very low calorie diet prepared in the hospital

Device: Very low calorie diet

Interventions

Very low calorie diet DEVICE

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

Very low calorie diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• body mass index ≥ 35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Special Hospital for Extended Treatment of Duga Resa

Duga Resa, 47250, Croatia

Location

Related Publications (17)

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  PMID: 25308439 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: June 14, 2019
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)