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 Malekahmadi, Mahsa, Moradi Moghaddam, Omid, Shariful Islam, Sheikh Mohammed, Tanha, Kiarash, Nematy, Mohsen, Pahlavani, Naseh, Firouzi, Safieh, Zali, Mohammad Reza and Norouzy, Abdolreza 2020, 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, vol. 21, pp. 1-9, doi: 10.1186/s13063-019-4008-x. Attached Files Name Description MIMEType Size Downloads Title 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 Author(s) Malekahmadi, Mahsa Moradi Moghaddam, Omid Shariful Islam, Sheikh Mohammed orcid.org/0000-0001-7926-9368 Tanha, Kiarash Nematy, Mohsen Pahlavani, Naseh Firouzi, Safieh Zali, Mohammad Reza Norouzy, Abdolreza Journal name Trials Volume number 21 Article ID 162 Start page 1 End page 9 Total pages 9 Publisher BMC Place of publication London, Eng. Publication date 2020 ISSN 1745-6215 Keyword(s) Critical care French maritime pine bark extract Inflammation Nutrition support Pycnogenol Traumatic brain injury Summary 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 patients. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol. Objective: The objective of this work is to survey the effect of pycnogenol on the clinical, nutritional, and inflammatory status of TBI patients. Methods: This 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. 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.  Language eng DOI 10.1186/s13063-019-4008-x Indigenous content off Field of Research 1102 Cardiorespiratory Medicine and Haematology 1103 Clinical Sciences HERDC Research category C1 Refereed article in a scholarly journal Free to Read? Yes Persistent URL http://hdl.handle.net/10536/DRO/DU:30135719 Document type: Journal Article Collections: Faculty of Health School of Exercise and Nutrition Sciences Institute for Physical Activity and Nutrition Open Access Collection Related Links Link Description Link to full-text (open access)     Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved. Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au. Versions Version Filter Type Sat, 21 Mar 2020, 03:52:10 EST Sat, 21 Mar 2020, 04:00:49 EST Mon, 23 Mar 2020, 07:01:31 EST Tue, 19 May 2020, 06:03:59 EST Fri, 22 May 2020, 11:43:01 EST Fri, 22 May 2020, 11:47:25 EST Filtered Full Citation counts:   Cited 0 times in TR Web of Science Cited 0 times in Scopus Search Google Scholar Access Statistics: 8 Abstract Views, 2 File Downloads  -  Detailed Statistics Created: Sat, 21 Mar 2020, 03:52:10 EST

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.