Effect of Enteral Genistein Supplementation in Sepsis

Phase 4

• Conditions: Sepsis
• Interventions: Other: enteral nutrition only; Dietary Supplement: Genistein

• Registration Number: NCT02796794
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-03-10
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-07
• Last Update Submitted: 2016-06-07
• Study First Posted: 2016-06-13
• Last Update Posted: 2016-06-13
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Presence of thyroid dysfunction
• Presence of hyperlipidemia
• Patients with nill by mouth and not receiving enteral nutrition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	enteral nutrition only	Control group are the patients receiving enteral nutrition
Genistein	Genistein	Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition

Primary Outcome Measures

Name	Time	Method
Change in Tumor necrosis factor alpha serum levels	Baseline, at 24th hour and at 72nd hour	It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in high-mobility group box 1 serum levels	Baseline, at 24th hour and at 72nd hour	It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in interleukin 1-beta serum levels	Baseline, at 24th hour and at 72nd hour	It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in interleukin 6 serum levels	Baseline, at 24th hour and at 72nd hour	It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	From date of randomization until 12 weeks	Patients will be followed until they are discharged from the hospital or death.
Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections	From date of randomization until 12 weeks	Patients will be followed until they are discharged from the hospital or death.
Length of intensive care unit and hospital stay (days)	From date of randomization until 12 weeks	Patients will be followed until they are discharged from the hospital or death.
Intensive care unit mortality rate, hospital mortality rate	From date of randomization until 12 weeks	Patients will be followed until they are discharged from the hospital or death.

Trial Locations

Locations (1)

Erciyes University Medical School; 🇹🇷 Kayseri, Turkey