A Phase 1/2 interventional study of Dietary Supplement (OLIGOPIN) and Placebo in Traumatic Brain Injury, sponsored by Mashhad University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-05-21.
Sponsored by Mashhad University of Medical Sciences · Phase 1/2, Interventional, and Treatment
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 67 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
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Exclusion Criteria:
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
Dietary Supplement: Dietary Supplement (OLIGOPIN)
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.
Other: 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 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.
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.
change of IL-6
Inflammatory markers
Time frame: 5 and 10 days
change of IL-1β
Inflammatory marker
Time frame: 5 and 10 days
change of CRP
Inflammatory marker
Time frame: 5 and 10 days
change of Malondialdehyde
Oxidative stress marker
Time frame: 5 and 10 days
change of total anti- oxidant capacity
anti-oxidative stress marker
Time frame: 5 and 10 days
change of weight
measurement is done via portable scale
Time frame: 5 and 10 days
change of body fat percentage
measurement is done via Bio impedance device "Inbody"
Time frame: 5 and 10 days
change of Body mass index
it is calculated by Equation
Time frame: 5 and 10 days
change of acute physiologic and chronic health evaluation II score
The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States. Interpretation: Score: 0-4: Death Rate (%):4, Score: 5-9:Death Rate (%):8, Score: 10-14:Death Rate (%):15, Score: 15-19:Death Rate (%):25, Score: 20-24:Death Rate (%):40, Score: 25-29:Death Rate (%):55, Score: 30-34:Death Rate (%):75. Score: ˃ 34 :Death Rate (%):85.
Time frame: 5 and 10 days
change of sequential organ failure assessment score
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The SOFA was designed to focus on organ dysfunction and morbidity, with less of an emphasis on mortality prediction. Interpretation: Score: 0-6: Death Rate (%):\< 10%, Score: 7-9:Death Rate (%):15 - 20%, Score: 10-12:Death Rate (%):40 - 50%, Score: 13-14:Death Rate (%):50 - 60%, Score: 15:Death Rate (%):\> 80%, Score: 15-24:Death Rate (%):\> 90%.
Time frame: 1, 3, 5, 7, 9, 10 days
change of Nutric score
The NUTRIC score (Nutrition assessment in critically ill) is a rapid assessment of nutritional state based on illness severity, age and co-morbidities. Sum of points: 6-10: CATEGORY: High Score. Sum of points: 0-5: CATEGORY: LOW Score High score associated with worse clinical outcomes (mortality, ventilation).These patients are the most likely to benefit from the aggressive nutrition therapy. LOW Score: These patients have a low malnutrition risk
Time frame: 5 and 10 days
28-day mortality
the rate of mortality
Time frame: 28 days
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Mashhad University of Medical Sciences