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
Abstract 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 are used. Intervention group will receive pycnogenol supplement 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein, IL-10) 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. Clinical and nutritional status will be assessed three times during the intervention. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked within 28 days of the start of the intervention. Weight, body mass index and body composition are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. Discussion we will expect supplementation of 150 mg pycnogenol improves clinical and nutritional status of the TBI patients and reduces inflammation and oxidative stress in the 10 days of intervention.