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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05055154
Other study ID # OSMN35aVLCD-26
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 14, 2019
Est. completion date November 3, 2020

Study information

Verified date September 2021
Source Special Hospital for Extended Treatment of Duga Resa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Obesity is a complex chronic multifactorial disease associated with concomitant or increased risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2 diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people with obesity can affect genome stability and have beneficial effects on insulin sensitivity, inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The aim of this study is to determine the effect of a three-week VLCD used in Special Hospital for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage, lipid profile, insulin resistance, inflammation and anthropometric parameters.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date November 3, 2020
Est. primary completion date November 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Very low calorie diet
In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks

Locations

Country Name City State
Croatia Special Hospital for Extended Treatment of Duga Resa Duga Resa

Sponsors (3)

Lead Sponsor Collaborator
Special Hospital for Extended Treatment of Duga Resa Institute for Medical Research and Occupational Health, University of Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Kamencic H, Lyon A, Paterson PG, Juurlink BH. Monochlorobimane fluorometric method to measure tissue glutathione. Anal Biochem. 2000 Nov 1;286(1):35-7. — View Citation

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. Epub 2003 Jan 30. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Setayesh T, Mišík M, Langie SAS, Godschalk R, Waldherr M, Bauer T, Leitner S, Bichler C, Prager G, Krupitza G, Haslberger A, Knasmüller 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. — View Citation

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. — View Citation

Ustundag B, Gungor S, Aygün 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. — View Citation

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary The changes in the body fat mass Body fat mass (kg) assessed with bioelectrical impedance method Baseline, after 3 weeks of VLCD
Primary The changes in the skeletal muscle mass Skeletal muscle mass (kg) assessed with bioelectrical impedance method Baseline, after 3 weeks of VLCD
Primary The changes in the percent body fat Percent body fat (%) assessed with bioelectrical impedance method Baseline, after 3 weeks of VLCD
Primary The changes in fasting glucose concentration Concentration of glucose (mmol/L) Baseline, after 3 weeks of VLCD
Primary The changes in urea concentration Concentration of urea (mmol/L) Baseline, after 3 weeks of VLCD
Primary 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
Primary The changes in insulin concentration Concentration of insulin (mIU/L) Baseline, after 3 weeks of VLCD
Primary 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
Primary 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 The changes in oxidative stress Concentration of glutathione (RFU) and reactive oxygen species (RFU) Baseline, after 3 weeks of VLCD
Secondary The changes in DNA damage Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes Baseline, after 3 weeks of VLCD
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