Evaluation the effects of pycnogenol (French maritime pine bark extract) supplementation on the inflammatory biomarkers, nutritional and clinical status in traumatic brain injury patients, in Intensive Care Unit; A Randomized Clinical Trial protocol

Background: 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 pycnogenol. Objective: surveying the effect of pycnogenol on the clinical, nutritional and inflammatory status of TBI patients. Methods: This is double-blind, randomized controlled trial . Block randomization will be used. Intervention group will receive pycnogenol supplementation of 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 5 th day and at the end of the study (10 th day) will be measured. Clinical and nutritional status will be assessed three times during the intervention. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure will be filled out every other day. The mortality rate will be calculated within 28 days of the start of the intervention. Weight, body mass index and body composition will be measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. Discussion: We expect that supplementation of 150 mg pycnogenol for 10 days will improve clinical and nutritional status and reduce the inflammation and oxidative stress of the TBI patients.