Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD
NCT ID: NCT05055154
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
26 participants
INTERVENTIONAL
2019-06-14
2020-11-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Changes in Anthropometric, Biochemical and DNA Damage Parameters After 3-weeks VLCD in Severely Obese Patients
NCT05007171
Effects of Caloric Restriction in Obesity and Type 2 Diabetes
NCT01930136
The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
NCT05643521
Effect of KETOgenic Diet on Metabolism, Inflammation, Nutrition Deficiencies and OXidative Stress in Women With Overweight
NCT05652972
The Acute Effects of Caloric Restriction on Anthropometrics, Metabolism, and Cardiovascular Health in Overweight Adults
NCT05422391
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Very low calorie diet
Use of very low calorie diet prepared in the hospital
Very low calorie diet
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Very low calorie diet
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute for Medical Research and Occupational Health
UNKNOWN
University of Zagreb
OTHER
Special Hospital for Extended Treatment of Duga Resa
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mirta Milic, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute for Medical Research and Occupational Health
Dragan Bozcevic, Doctor
Role: PRINCIPAL_INVESTIGATOR
Special Hospital for Extended Treatment of Duga Resa
Ana-Marija Domijan, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Zagreb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Special Hospital for Extended Treatment of Duga Resa
Duga Resa, , Croatia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Grindel A, Brath H, Nersesyan A, Knasmueller S, Wagner KH. Association of Genomic Instability with HbA1c levels and Medication in Diabetic Patients. Sci Rep. 2017 Feb 2;7:41985. doi: 10.1038/srep41985.
Franzke B, Schwingshackl L, Wagner KH. Chromosomal damage measured by the cytokinesis block micronucleus cytome assay in diabetes and obesity - A systematic review and meta-analysis. Mutat Res Rev Mutat Res. 2020 Oct-Dec;786:108343. doi: 10.1016/j.mrrev.2020.108343. Epub 2020 Nov 2.
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.
Kamencic H, Lyon A, Paterson PG, Juurlink BH. Monochlorobimane fluorometric method to measure tissue glutathione. Anal Biochem. 2000 Nov 1;286(1):35-7. doi: 10.1006/abio.2000.4765.
Kalyanaraman B, Darley-Usmar V, Davies KJ, Dennery PA, Forman HJ, Grisham MB, Mann GE, Moore K, Roberts LJ 2nd, Ischiropoulos H. Measuring reactive oxygen and nitrogen species with fluorescent probes: challenges and limitations. Free Radic Biol Med. 2012 Jan 1;52(1):1-6. doi: 10.1016/j.freeradbiomed.2011.09.030. Epub 2011 Oct 2.
Ustundag B, Gungor S, Aygun AD, Turgut M, Yilmaz E. Oxidative status and serum leptin levels in obese prepubertal children. Cell Biochem Funct. 2007 Sep-Oct;25(5):479-83. doi: 10.1002/cbf.1334.
Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
Keaney JF Jr, Larson MG, Vasan RS, Wilson PW, Lipinska I, Corey D, Massaro JM, Sutherland P, Vita JA, Benjamin EJ; Framingham Study. Obesity and systemic oxidative stress: clinical correlates of oxidative stress in the Framingham Study. Arterioscler Thromb Vasc Biol. 2003 Mar 1;23(3):434-9. doi: 10.1161/01.ATV.0000058402.34138.11. Epub 2003 Jan 30.
Il'yasova D, Wang F, Spasojevic I, Base K, D'Agostino RB Jr, Wagenknecht LE. Racial differences in urinary F2-isoprostane levels and the cross-sectional association with BMI. Obesity (Silver Spring). 2012 Oct;20(10):2147-50. doi: 10.1038/oby.2012.170. Epub 2012 Jun 22.
Kobayashi H, Matsuda M, Fukuhara A, Komuro R, Shimomura I. Dysregulated glutathione metabolism links to impaired insulin action in adipocytes. Am J Physiol Endocrinol Metab. 2009 Jun;296(6):E1326-34. doi: 10.1152/ajpendo.90921.2008. Epub 2009 Apr 14.
Tormos KV, Anso E, Hamanaka RB, Eisenbart J, Joseph J, Kalyanaraman B, Chandel NS. Mitochondrial complex III ROS regulate adipocyte differentiation. Cell Metab. 2011 Oct 5;14(4):537-44. doi: 10.1016/j.cmet.2011.08.007.
Won HY, Sohn JH, Min HJ, Lee K, Woo HA, Ho YS, Park JW, Rhee SG, Hwang ES. Glutathione peroxidase 1 deficiency attenuates allergen-induced airway inflammation by suppressing Th2 and Th17 cell development. Antioxid Redox Signal. 2010 Sep 1;13(5):575-87. doi: 10.1089/ars.2009.2989.
Bozinovski S, Seow HJ, Crack PJ, Anderson GP, Vlahos R. Glutathione peroxidase-1 primes pro-inflammatory cytokine production after LPS challenge in vivo. PLoS One. 2012;7(3):e33172. doi: 10.1371/journal.pone.0033172. Epub 2012 Mar 6.
Picklo MJ, Long EK, Vomhof-DeKrey EE. Glutathionyl systems and metabolic dysfunction in obesity. Nutr Rev. 2015 Dec;73(12):858-68. doi: 10.1093/nutrit/nuv042. Epub 2015 Oct 22.
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.
Santovito A, Gendusa C. Micronuclei frequency in peripheral blood lymphocytes of healthy subjects living in turin (North-Italy): contribution of body mass index, age and sex. Ann Hum Biol. 2020 Feb;47(1):48-54. doi: 10.1080/03014460.2020.1714728. Epub 2020 Jan 23.
Donmez-Altuntas H, Sahin F, Bayram F, Bitgen N, Mert M, Guclu K, Hamurcu Z, Aribas S, Gundogan K, Diri H. Evaluation of chromosomal damage, cytostasis, cytotoxicity, oxidative DNA damage and their association with body-mass index in obese subjects. Mutat Res Genet Toxicol Environ Mutagen. 2014 Sep 1;771:30-6. doi: 10.1016/j.mrgentox.2014.06.006. Epub 2014 Jun 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OSMN35aVLCD-26
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.