NCT02796794

Effect of Enteral Genistein Supplementation in Sepsis

Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Genistein	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
OTHER	enteral nutrition only	These are the patients receiving enteral nutrition

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-06-13
• Last updated: 2016-06-13

Locations

1 site across 1 country: Turkey (Türkiye)