Effect of Epigallocatechin -3-gallate Supplementation in Traumatic Brain Injury Patients

Traumatic Brain Injury Clinical Trial

Official title:

Effect of Green Tea Epigallocatechin -3-gallate Supplementation on Traumatic Brain Injury Patients' Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731495
• Other study ID #: 24513540293
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 17, 2016
• Last updated: June 6, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Traumatic brain injury is the leading cause of death and disability in young adults. Green tea Epigallocatechin -3-gallate (EGCG) supplementation might favorably influenced many of the processes mention in the secondary insult of TBI including neuroinflammation and antioxidative damages.

The investigators aim to investigate whether treatment with Epigallocatechin -3-gallate favorably affect outcomes in traumatic brain injury patients. Therefore, in the current randomized double-blind clinical trial, 30 patients (15 patients in each group) with moderate to severe head trauma admitted to university hospital intensive care unit will included. Patients will either receive a daily oral dose of 400 mg EGCG or placebo for 7 days. The major outcomes includes duration of mechanical ventilation, Glasgow Coma Scale (GCS), and S100 protein level.

Description:

Male patients (16-65 year old) who admitted to a university hospital intensive care unit with moderate to severe Traumatic Brain Injury (TBI) were enrolled using consecutive sampling. Inclusion criteria were GCS of 4-12, enteral nutrition started in 24 hours after admission, having mechanical ventilation. The procedure and protocol of the study was approved by the Ethic Committee of Tehran University of Medical Sciences. Written informed consent were obtained from patient's relative. After recording anamnesis, patients were examined physically. Urgent actions were done, simple radiography were taken from skull and CT-scan were performed if it is necessary. Patients who had internal bleeding, obvious fractures in their limbs, history of metabolic or psychiatric disorder, alcohol or drug dependency, underlying diseases, or vegetarian diet would be excluded from the study. Patients' base line information including age, sex, vital signs, GCS, clinical symptoms at time of reception, diagnosis based on CT-scan, type of treatment (medicinal or surgical) and surgical area of body were recorded. patients were then divided into two experimental groups: (1) receiving epigallocatechin gallate (EGCG) supplement (case group, n = 15) and (2) receiving placebo (control group, n = 15). EGCG supplement was in the form of 400 mg oral capsules with a purity of 80% catechin. EGCG powder of each capsule was dissolved in 10 ml deionized water and given to patients via gavage (1 capsule per day) for a week. Placebo group only received 10 ml of deionized water via gavage for a week. During that week, GCS of patients was recorded by a neurosurgery resident who was blinded. For seven days, vital signs, glucose, hematocrit, haemoglobin, platelet were recorded every day at 9:00 a.m. Duration of the connection to mechanical ventilation was also recorded.

In order to analyze serum S100B protein level, 5 ml serum was taken from patients at 1st day and 8th day of the admission and stored at -80⁰C. Human S100B ELISA kit was used to quantify the level of S100B protein.

Statistical analysis

distribution of all continuous variables was assessed using Kolmogorov-Smirnov test. Normal distributed variables were compared by independent samples t-test. Not-normal distributed variables were assessed by Wilcoxon-Mann-Whitney U-test. P value less than .05 would be considered as statistically significant for all tests. Data were analyzed using SPSS Statistics version 21 (SPSS Inc., Chicago, USA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• GCS of 4-12

• enteral nutrition started in 24 hours after admission

• having mechanical ventilation.

Exclusion Criteria:

• internal bleeding

• obvious fractures in limbs

• history of metabolic or psychiatric disorder

• alcohol or drug dependency

• underlying diseases

• vegetarian diet

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Dietary Supplement:
• EGCG
EGCG (Epigallocatechin -3-gallate)
• Placebo (deionized water)

Locations

Country	Name	City	State
Iran, Islamic Republic of	NNFTRI clinic	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Coma Scale (GCS)		7 days	No
Primary	Duration of mechanical ventilation	Duration of mechanical ventilation is recorded by a nurse who is blinded to grouping and reported in days.	14 days	No
Primary	ICU stay		14 days	No
Primary	Serum S100 level		7 days	No