NCT02796794

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 sepsis

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

March 10, 2016

Last Update Submit

June 7, 2016

Conditions

Sepsis

Keywords

Enteral nutritionGenisteinCytokine

Outcome Measures

Primary Outcomes (4)

  • Change in Tumor necrosis factor alpha serum levels

    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

    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

    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

    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 Outcomes (4)

  • Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections

    From date of randomization until 12 weeks

  • Length of intensive care unit and hospital stay (days)

    From date of randomization until 12 weeks

  • Duration of mechanical ventilation

    From date of randomization until 12 weeks

  • Intensive care unit mortality rate, hospital mortality rate

    From date of randomization until 12 weeks

Study Arms (2)

Genistein

ACTIVE COMPARATOR

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

Dietary Supplement: Genistein

control

OTHER

Control group are the patients receiving enteral nutrition

Other: enteral nutrition only

Interventions

GenisteinDIETARY_SUPPLEMENT

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

Genistein
enteral nutrition onlyOTHER

These are the patients receiving enteral nutrition

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Medical School

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Souza LR, Silva E, Calloway E, Kucuk O, Rossi M, McLemore ML. Genistein protects hematopoietic stem cells against G-CSF-induced DNA damage. Cancer Prev Res (Phila). 2014 May;7(5):534-44. doi: 10.1158/1940-6207.CAPR-13-0295. Epub 2014 Mar 10.

    PMID: 24614013BACKGROUND

  • Lazarevic B, Hammarstrom C, Yang J, Ramberg H, Diep LM, Karlsen SJ, Kucuk O, Saatcioglu F, Tasken KA, Svindland A. The effects of short-term genistein intervention on prostate biomarker expression in patients with localised prostate cancer before radical prostatectomy. Br J Nutr. 2012 Dec 28;108(12):2138-47. doi: 10.1017/S0007114512000384. Epub 2012 Mar 8.

    PMID: 22397815BACKGROUND

  • Hong H, Landauer MR, Foriska MA, Ledney GD. Antibacterial activity of the soy isoflavone genistein. J Basic Microbiol. 2006;46(4):329-35. doi: 10.1002/jobm.200510073.

    PMID: 16847837BACKGROUND

  • Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.

    PMID: 23984731BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Genistein

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Kursat Gundogan, MD

CONTACT

+90 352 207 6666kgundogan@erciyes.edu.tr

Murat Sungur, MD

CONTACT

+90 352 207 6666msungur@erciyes.edu.tr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 10, 2016

First Posted

June 13, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

TU(1)