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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.

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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 MohammedORCID iD for 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

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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.