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| Name | Class |
|---|---|
| Institute for Medical Research and Occupational Health | UNKNOWN |
| University of Zagreb | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very low calorie diet | Experimental | Use of very low calorie diet prepared in the hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low calorie diet | Device | In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in oxidative stress | Concentration of glutathione (RFU) and reactive oxygen species (RFU) | Baseline, after 3 weeks of VLCD |
| The changes in DNA damage | Frequency of micronucleus, nuclear buds, nucleoplasmic bridges, apoptotic and necrotic cells among 1000 lymphocytes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Special Hospital for Extended Treatment of Duga Resa | Duga Resa | 47250 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28150817 | Background | 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. | |
| 33339574 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| Baseline, after 3 weeks of VLCD |
| 24674997 | Background | 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. |
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| 12615693 | Background | 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. |
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| 20367278 | Background | 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. |
| 22412999 | Background | 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. |
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| 31141317 | Background | 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. |
| 31969023 | Background | 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. |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |