Effect of Enteral Genistein Supplementation in Sepsis

TC Erciyes University

Status and phase: Unknown; Phase 4

Conditions: Sepsis

Treatments: Other: enteral nutrition only; Dietary Supplement: Genistein

Study type: Interventional

Funder types: Other

Identifiers

NCT02796794

2014/341

Details and patient eligibility

About

To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Criteria: inclusion criteria:

• Patients with sepsis above 18 years of age.
• Expected duration of ICU survival more than 48 hours.
• Patients receiving enteral nutrition (EN)
• Sepsis diagnosis within first 12 hours

Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Genistein

Active Comparator group

Description:

Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition

Treatment:

Dietary Supplement: Genistein

control

Other group

Description:

Control group are the patients receiving enteral nutrition

Treatment:

Other: enteral nutrition only