NCT05007171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

July 16, 2021

Last Update Submit

August 10, 2021

Conditions

ObesityWeight LossDNA Damage

Keywords

ObesityVery low calorie dietAlkine comet assayFPG oxidative comet assayDNA damage

Outcome Measures

Primary Outcomes (11)

  • 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)

    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 insulin concentration

    Concentration of insulin (mIU/L)

    Baseline, after 3 weeks of VLCD

  • The changes in HOMA index

    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

    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

    Concentration of C-reactive protein (mg/L)

    Baseline, after 3 weeks of VLCD

  • The changes in inflammation parameters

    Concentration of total white blood cell count

    Baseline, after 3 weeks of VLCD

Secondary Outcomes (3)

  • The changes in DNA damage assessed with alkaline comet assay

    Baseline, after 3 weeks of VLCD

  • The changes in DNA damage assessed with alkaline comet assay

    Baseline, after 3 weeks of VLCD

  • The changes in oxidative DNA damage assessed with FPG comet assay

    Baseline, after 3 weeks of VLCD

Study Arms (1)

Very low calorie diet

EXPERIMENTAL

Use of very low calorie diet in hospital for 3 weeks

Device: Very low calorie diet

Interventions

Very low calorie dietDEVICE

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

Very low calorie diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Hospital for Extended Treatment of Duga Resa

Duga Resa, City of Zagreb, 47250, Croatia

Location

Related Publications (18)

  • Usman M, Volpi EV. DNA damage in obesity: Initiator, promoter and predictor of cancer. Mutat Res Rev Mutat Res. 2018 Oct-Dec;778:23-37. doi: 10.1016/j.mrrev.2018.08.002. Epub 2018 Aug 17.

    PMID: 30454680BACKGROUND

  • Himbert C, Thompson H, Ulrich CM. Effects of Intentional Weight Loss on Markers of Oxidative Stress, DNA Repair and Telomere Length - a Systematic Review. Obes Facts. 2017;10(6):648-665. doi: 10.1159/000479972. Epub 2017 Dec 14.

    PMID: 29237161BACKGROUND

  • Wlodarczyk M, Nowicka G. Obesity, DNA Damage, and Development of Obesity-Related Diseases. Int J Mol Sci. 2019 Mar 6;20(5):1146. doi: 10.3390/ijms20051146.

    PMID: 30845725BACKGROUND

  • Hart RW, Dixit R, Seng J, Turturro A, Leakey JE, Feuers R, Duffy P, Buffington C, Cowan G, Lewis S, Pipkin J, Li SY. Adaptive role of caloric intake on the degenerative disease processes. Toxicol Sci. 1999 Dec;52(2 Suppl):3-12. doi: 10.1093/toxsci/52.2.3.

    PMID: 10630584BACKGROUND

  • Heydari AR, Unnikrishnan A, Lucente LV, Richardson A. Caloric restriction and genomic stability. Nucleic Acids Res. 2007;35(22):7485-96. doi: 10.1093/nar/gkm860. Epub 2007 Oct 16.

    PMID: 17942423BACKGROUND

  • Setayesh T, Nersesyan A, Misik M, Ferk F, Langie S, Andrade VM, Haslberger A, Knasmuller S. Impact of obesity and overweight on DNA stability: Few facts and many hypotheses. Mutat Res Rev Mutat Res. 2018 Jul-Sep;777:64-91. doi: 10.1016/j.mrrev.2018.07.001. Epub 2018 Jul 11.

    PMID: 30115431BACKGROUND

  • Setayesh T, Misik M, Langie SAS, Godschalk R, Waldherr M, Bauer T, Leitner S, Bichler C, Prager G, Krupitza G, Haslberger A, Knasmuller S. Impact of Weight Loss Strategies on Obesity-Induced DNA Damage. Mol Nutr Food Res. 2019 Sep;63(17):e1900045. doi: 10.1002/mnfr.201900045. Epub 2019 Jun 14.

    PMID: 31141317BACKGROUND

  • Harper C, Maher J, Grunseit A, Seimon RV, Sainsbury A. Experiences of using very low energy diets for weight loss by people with overweight or obesity: a review of qualitative research. Obes Rev. 2018 Oct;19(10):1412-1423. doi: 10.1111/obr.12715. Epub 2018 Aug 24.

    PMID: 30144269BACKGROUND

  • Parretti HM, Jebb SA, Johns DJ, Lewis AL, Christian-Brown AM, Aveyard P. Clinical effectiveness of very-low-energy diets in the management of weight loss: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2016 Mar;17(3):225-34. doi: 10.1111/obr.12366. Epub 2016 Jan 18.

    PMID: 26775902BACKGROUND

  • Milic M, Ozvald I, Vinkovic Vrcek I, Vucic Lovrencic M, Orescanin V, Bonassi S, Del Castillo ER. Alkaline comet assay results on fresh and one-year frozen whole blood in small volume without cryo-protection in a group of people with different health status. Mutat Res Genet Toxicol Environ Mutagen. 2019 Jul;843:3-10. doi: 10.1016/j.mrgentox.2019.03.009. Epub 2019 Mar 28.

    PMID: 31421735BACKGROUND

  • Milic M, Kisan M, Rogulj D, Radman M, Lovrencic MV, Konjevoda P, Domijan AM. Level of primary DNA damage in the early stage of metabolic syndrome. Mutat Res Genet Toxicol Environ Mutagen. 2013 Dec 12;758(1-2):1-5. doi: 10.1016/j.mrgentox.2013.07.013. Epub 2013 Sep 27.

    PMID: 24076402BACKGROUND

  • Rogulj D, Konjevoda P, Milic M, Mladinic M, Domijan AM. Fatty liver index as an indicator of metabolic syndrome. Clin Biochem. 2012 Jan;45(1-2):68-71. doi: 10.1016/j.clinbiochem.2011.10.014. Epub 2011 Oct 26.

    PMID: 22056738BACKGROUND

  • Langie SA, Azqueta A, Collins AR. The comet assay: past, present, and future. Front Genet. 2015 Aug 13;6:266. doi: 10.3389/fgene.2015.00266. eCollection 2015. No abstract available.

    PMID: 26322077BACKGROUND

  • Mulligan AA, Luben RN, Bhaniani A, Parry-Smith DJ, O'Connor L, Khawaja AP, Forouhi NG, Khaw KT; EPIC-Norfolk FFQ Study. A new tool for converting food frequency questionnaire data into nutrient and food group values: FETA research methods and availability. BMJ Open. 2014 Mar 27;4(3):e004503. doi: 10.1136/bmjopen-2013-004503.

    PMID: 24674997BACKGROUND

  • Heilbronn LK, de Jonge L, Frisard MI, DeLany JP, Larson-Meyer DE, Rood J, Nguyen T, Martin CK, Volaufova J, Most MM, Greenway FL, Smith SR, Deutsch WA, Williamson DA, Ravussin E; Pennington CALERIE Team. Effect of 6-month calorie restriction on biomarkers of longevity, metabolic adaptation, and oxidative stress in overweight individuals: a randomized controlled trial. JAMA. 2006 Apr 5;295(13):1539-48. doi: 10.1001/jama.295.13.1539.

    PMID: 16595757BACKGROUND

  • Snel M, Jonker JT, Hammer S, Kerpershoek G, Lamb HJ, Meinders AE, Pijl H, de Roos A, Romijn JA, Smit JW, Jazet IM. Long-term beneficial effect of a 16-week very low calorie diet on pericardial fat in obese type 2 diabetes mellitus patients. Obesity (Silver Spring). 2012 Aug;20(8):1572-6. doi: 10.1038/oby.2011.390. Epub 2012 Jan 26.

    PMID: 22282049BACKGROUND

  • Portnay GI, O'Brian JT, Bush J, Vagenakis AG, Azizi F, Arky RA, Ingbar SH, Braverman LE. The effect of starvation on the concentration and binding of thyroxine and triiodothyronine in serum and on the response to TRH. J Clin Endocrinol Metab. 1974 Jul;39(1):191-4. doi: 10.1210/jcem-39-1-191. No abstract available.

    PMID: 4835133BACKGROUND

  • Ozvald I, Bozicevic D, Duh L, Vinkovic Vrcek I, Domijan AM, Milic M. Changes in anthropometric, biochemical, oxidative, and DNA damage parameters after 3-weeks-567-kcal-hospital-controlled-VLCD in severely obese patients with BMI >/= 35 kg m-2. Clin Nutr ESPEN. 2022 Jun;49:319-327. doi: 10.1016/j.clnesp.2022.03.028. Epub 2022 Mar 26.

    PMID: 35623833DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Mirta Milic, PhD

    Institute for Medical Research and Occupational Health

    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

July 16, 2021

First Posted

August 16, 2021

Study Start

June 14, 2019

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

August 16, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)