Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-29 @ 4:06 AM
Study NCT ID:
NCT02796794
Status:
UNKNOWN
Last Update Posted:
2016-06-13
First Post:
2016-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Enteral Genistein Supplementation in Sepsis
Sponsor:
TC Erciyes University
Organization:
Study Overview
Official Title:
Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis
Detailed Description:
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
1. Addition of genistein to enteral nutrition in patients with sepsis can play an important role to decrease inflammatory cytokines.
2. Morbidity can be decreased with lower levels of inflammatory cytokines in patients with sepsis.
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
1. Addition of genistein to enteral nutrition in patients with sepsis can play an important role to decrease inflammatory cytokines.
2. Morbidity can be decreased with lower levels of inflammatory cytokines in patients with sepsis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: