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To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis
Sepsis is a state develops as a response to severe infection with high mortality rate. Incidence of sepsis among patients admitted to hospitals is 2%. Annual incidence of sepsis is 50-95 for 100.000 population and incidence is increasing approximately 9% each year. Severe sepsis and septic shock is the most frequent reason for mortality in intensive care units (ICU). There is exaggerated and irregular host response in sepsis. Cytokines such as interleukin-1, interleukin-6, interleukin-8, tumor necrosis factor-α, Interferon-γ and high mobility group box-1 are released as response to invading microorganisms and they play a major role in sepsis pathogenesis.
Soybean proteins are used for prevention and treatment of cardiovascular diseases, osteoporosis and different cancer types.
Soy isoflavones such as genistein, daidzein and glycitein are the main components for cancer prevention. Genistein is the dominant isoflavones.
The main mechanism for anti-inflammatory effect of genistein is related to transcription nuclear factor (NF-kB) and inhibition of chemokine-8. The risk for prostate cancer was proven to decrease in epidemiological studies.
NF-kB plays a central role for inflammatory cytokine release, prevents apoptosis and induces tumor cell growth. The effect of topoisomerase II inhibitory chemotherapeutic agents is increased with NF-kB inhibition.
Hypothesis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genistein | Active Comparator | Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition |
|
| control | Other | Control group are the patients receiving enteral nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genistein | Dietary Supplement | Total 30 patients will be included into the study They will be divided into two groups each containing 15 patients. Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tumor necrosis factor alpha serum levels | It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study | Baseline, at 24th hour and at 72nd hour |
| Change in interleukin 1-beta serum levels | It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study | Baseline, at 24th hour and at 72nd hour |
| Change in interleukin 6 serum levels | It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study | Baseline, at 24th hour and at 72nd hour |
| Change in high-mobility group box 1 serum levels | It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study | Baseline, at 24th hour and at 72nd hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections | Patients will be followed until they are discharged from the hospital or death. | From date of randomization until 12 weeks |
| Length of intensive care unit and hospital stay (days) |
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Criteria: inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kursat Gundogan, MD | Contact | +90 352 207 6666 | 21919 | kgundogan@erciyes.edu.tr |
| Murat Sungur, MD | Contact | +90 352 207 6666 | 21912 | msungur@erciyes.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University Medical School | Recruiting | Kayseri | 38039 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24614013 | Background | Souza LR, Silva E, Calloway E, Kucuk O, Rossi M, McLemore ML. Genistein protects hematopoietic stem cells against G-CSF-induced DNA damage. Cancer Prev Res (Phila). 2014 May;7(5):534-44. doi: 10.1158/1940-6207.CAPR-13-0295. Epub 2014 Mar 10. | |
| 22397815 | Background | Lazarevic B, Hammarstrom C, Yang J, Ramberg H, Diep LM, Karlsen SJ, Kucuk O, Saatcioglu F, Tasken KA, Svindland A. The effects of short-term genistein intervention on prostate biomarker expression in patients with localised prostate cancer before radical prostatectomy. Br J Nutr. 2012 Dec 28;108(12):2138-47. doi: 10.1017/S0007114512000384. Epub 2012 Mar 8. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| enteral nutrition only | Other | These are the patients receiving enteral nutrition |
|
Patients will be followed until they are discharged from the hospital or death. |
| From date of randomization until 12 weeks |
| Duration of mechanical ventilation | Patients will be followed until they are discharged from the hospital or death. | From date of randomization until 12 weeks |
| Intensive care unit mortality rate, hospital mortality rate | Patients will be followed until they are discharged from the hospital or death. | From date of randomization until 12 weeks |
| 16847837 | Background | Hong H, Landauer MR, Foriska MA, Ledney GD. Antibacterial activity of the soy isoflavone genistein. J Basic Microbiol. 2006;46(4):329-35. doi: 10.1002/jobm.200510073. |
| 23984731 | Background | Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |