Effect of Enteral Genistein Supplementation in Sepsis

June 7, 2016 updated by: Kursat Gundogan, TC Erciyes University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38039
        • Recruiting
        • Erciyes University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Genistein
Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition
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: control
Control group are the patients receiving enteral nutrition
Other: enteral nutrition only
These are the patients receiving enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tumor necrosis factor alpha serum levels
Time Frame: 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
Baseline, at 24th hour and at 72nd hour
Change in interleukin 1-beta serum levels
Time Frame: 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
Baseline, at 24th hour and at 72nd hour
Change in interleukin 6 serum levels
Time Frame: 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
Baseline, at 24th hour and at 72nd hour
Change in high-mobility group box 1 serum levels
Time Frame: 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
Baseline, at 24th hour and at 72nd hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections
Time Frame: From date of randomization until 12 weeks
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)
Time Frame: From date of randomization until 12 weeks
Patients will be followed until they are discharged from the hospital or death.
From date of randomization until 12 weeks
Duration of mechanical ventilation
Time Frame: From date of randomization until 12 weeks
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
Time Frame: From date of randomization until 12 weeks
Patients will be followed until they are discharged from the hospital or death.
From date of randomization until 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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