Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients

NCT ID: NCT03777683

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-14
• Study Completion Date: 2020-02-20

Brief Summary

Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine bark extract.

Objective: The main objective of present study is surveying the effect of French maritime pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the first human study in the world.

Method: this is double-blind, randomized controlled trial. Block randomization are used. Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for assessment of clinical status of patients and Nutric questionnaires for assessment of nutritional status filled out at the base line, 5th day and the end of study. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked by phone within 28 days of the start of the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th day of intervention are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.

Detailed Description

Randomization:

investigators randomly assign eligible patients on enrolment (1:1) to either the control group or the intervention group. Randomization is stratified by site and a randomization list of unique patient identifiers is generated by the study statistician using a computer-generated random block size. The classification is based on age (18 to 40 and 40 to 65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using quadruple blocks.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dietary Supplement (OLIGOPIN)

Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) in the form oral capsules containing 50 mg French maritime pine bark extract plus 130 mg Microcrystalline Cellulose. OLIGOPIN powder of each capsule are dissolved in 10 ml deionized water and given to patients via gavage (3 capsule per day) for 10 days

Group Type: EXPERIMENTAL

Dietary Supplement (OLIGOPIN)

Intervention Type: DIETARY_SUPPLEMENT

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

Placebo

Control group will receive oral capsules containing 130 mg Microcrystalline Cellulose with 10 ml of deionized water via gavage (3 capsule per day) for 10 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

Interventions

Dietary Supplement (OLIGOPIN)

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Admission in ICU due to TBI2
• 18 year ≤ age ≤ 65 year
• GCS score ˃ 8
• Stable hemodynamic and metabolic status in the first 24 to 48 hours
• Having enteral nutritional support
• Fill out the informed consent form by the patient or first-degree relatives of the patient

Exclusion Criteria

• Pregnancy and lactation
• Morbid obesity: BMI ≥ 40
• Failure to start enteral nutrition in the first 24-48 hours
• Suffering from autoimmune disorders and HIV/Aids
• Suffering or having History of cancer and any liver failure
• Receiving positive inotropic medications including Dopamine, Dobutamine and Epinephrine
• Severe and active bleeding
• Suffering from Sepsis
• Having history of known food allergies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mahsa Malekahmadi

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mahsa Malekahmadi

Tehran, , Iran

Countries

Iran

References

Malekahmadi M, Moradi Moghaddam O, Islam SMS, Tanha K, Nematy M, Pahlavani N, Firouzi S, Zali MR, Norouzy A. Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol. Trials. 2020 Feb 11;21(1):162. doi: 10.1186/s13063-019-4008-x.

Reference Type: DERIVED

PMID: 32046747 (View on PubMed)

Other Identifiers

970612

Identifier Type: -

Identifier Source: org_study_id