Abstract
BackgroundTraumatic 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 patients. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol.ObjectiveThe objective of this work is to survey the effect of pycnogenol on the clinical, nutritional, and inflammatory status of TBI patients.MethodsThis is a double-blind, randomized controlled trial. Block randomization will be used. An intervention group will receive pycnogenol supplementation of 150 mg for 10 days and a control group will receive a placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (malondialdehyde, total antioxidant capacity), at the baseline, at the 5th day, and at the end of the study (10th day) will be measured. Clinical and nutritional status will be assessed three times during the intervention. The Sequential Organ Failure Assessment (SOFA) 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 an initially assigned study arm in an intention-to-treat analysis.DiscussionWe 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.Trial registrationThis trial is registered at clinicaltrials.gov (ref: NCT03777683) at 12/13/2018.
Highlights
Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world
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
The main objective of the present study is to study the effect of PYC on the clinical, nutritional, and inflammatory status of TBI patients as the first human study in the world
Summary
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 patients. Traumatic brain injury Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world [1]. It is prevalent in both developed and developing societies and affects people of all ages. TBI causes about 1.5 million deaths and hospitalizations per year in the USA [3]. TBI is more common among teens and young adult aged 15–45 years, mainly due to road accidents and sportrelated events. Men are three times more likely to be injured and more severely damaged [4]
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