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Article: Fabrication and characterization of synthesized hydroxyapatite/ethanolamine for bone tissue engineering application

Shahgholi, Mohamad / Karimipour, Arash / Firouzi, Pouya / Malekahmadi, Omid / Ghashang, Majid / Saadoon, Nasier / Obaid, Noor H. / Baghaei, Shaghayegh

Colloids and surfaces. 2022 Oct. 05, v. 650

2022

Abstract: With advances in thermal science, one of the research interests is to develop biomedical liquid-flow devices. In the field of dental implant surgery, the application of hydroxyapatite-coated metallic implants has been investigated to a great extent. In ... ...

Abstract	With advances in thermal science, one of the research interests is to develop biomedical liquid-flow devices. In the field of dental implant surgery, the application of hydroxyapatite-coated metallic implants has been investigated to a great extent. In this research, hydroxyapatite (HA) was reinforced with ethanolamine to enhance HA's physical properties. Afterward, Titanium dioxide was ball-milled along with reinforced-hydroxyapatite to make the HA-TiO₂ composite. Characterization tests such as XRD-XRF, FTIR, FESEM, and TEM were done and verified the composition. Moreover, heat transfer of HA-TiO₂ was investigated at different volume fractions (0.2–1.0 vol%) and various temperatures (20–50 °C). Finally, a model of artificial neural network (ANN) was trained and presented to forecast the heat transfer in water-based and SBF-based nanofluids. Heat transfer enhancement for HA30%-Titanium Dioxide/Water (at 1.0 vol% and 50 °C) was 9.665%, and for HA30%-Titanium Dioxide/SBF was 9.196% comparing with base fluid. Also, the Orthogonal Distance Regression (ODR) algorithm in ANN modeling, in comparison with ODR in Levenberg Marquardt, displayed an error decrement of 0.6456961% in the water-based Hybrid Nanofluid (HN) and 0.0000607% in the SBF-based HN, respectively. This research proves that HA. Ethanolamine-TiO₂ composite can be used as a dental implant with acceptable heat transfer and physical properties.
Keywords	algorithms ; bones ; dental prosthesis ; ethanolamine ; heat transfer ; hydroxyapatite ; nanofluids ; neural networks ; surgery ; titanium dioxide
Language	English
Dates of publication	2022-1005
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	1500517-3
ISSN	0927-7757
ISSN	0927-7757
DOI	10.1016/j.colsurfa.2022.129591
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Effect of enteral immunomodulatory nutrition formula on mortality and critical care parameters in critically ill patients: A systematic review with meta-analysis.

Malekahmadi, Mahsa / Pahlavani, Naseh / Firouzi, Safieh / Clayton, Zachary S / Islam, Sheikh Mohammed Shariful / Rezaei Zonooz, Sanaz / Moradi Moghaddam, Omid / Soltani, Sepideh

Nursing in critical care

2021 Volume 27, Issue 6, Page(s) 838–848

Abstract: Background: Enteral immunomodulatory nutrition is recommended as an adjuvant therapy for patients in intensive care units (ICU), but its effectiveness is incompletely understood.: Aim: The aim of this review was to examine the effect of a commonly ... ...

Abstract	Background: Enteral immunomodulatory nutrition is recommended as an adjuvant therapy for patients in intensive care units (ICU), but its effectiveness is incompletely understood. Aim: The aim of this review was to examine the effect of a commonly used immunomodulatory formula-omega-3 fatty acids, γ-linolenic acid, and antioxidants-on clinical outcomes and mortality risk in critically ill patients. Design: Systematic review and meta-analysis of randomized controlled trials (RCTs). Method: PubMed, Scopus, and Institute for Scientific Information (ISI) Web of Knowledge databases were searched until 18 February 2021. RCTs that used the immunomodulatory formula in the ICU were included. Results: Ten RCTs (1166 participants) were included in the meta-analysis. The immunomodulatory formula reduced the duration of ICU stay weighted mean difference [(WMD): -2.97 days; 95%CI: -5.59, -0.35)], mechanical ventilation (WMD = -2.20 days, 95%CI: -4.29, -0.10), sequential organ failure assessment and multiple organ dysfunction scores (Hedge's g: -0.42 U/L; 95% CI: -0.74, -0.11), decreased 8-day overall mortality risk (RR = 0.74, 95% CI: 0.58, 0.91), and extended the ICU-free days (WMD: 4.06 days, 95% CI: 0.02, 8.09). The improvement in respiratory function and reduction in mortality risk was more in patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS). Furthermore, the reduction in mechanical ventilation and mortality risk was more evident in older (>60 years) vs young adults. Conclusion and relevance to clinical practice: Taken together, the immunomodulatory formula may enhance clinical practice for critical care nurses, such that the prevalence and/or susceptibility to secondary conditions commonly encountered in the ICU (ie, ALI and ARDS) could be attenuated, ultimately allowing critical care nurses to focus their care on the primary reason for which a patient is in the ICU. The study protocol was registered in PROSPERO.
MeSH term(s)	Humans ; Aged ; Critical Illness/therapy ; Critical Care ; Enteral Nutrition/methods ; Respiration, Artificial ; Respiratory Distress Syndrome/therapy ; Intensive Care Units ; Length of Stay
Language	English
Publishing date	2021-07-29
Publishing country	England
Document type	Meta-Analysis ; Systematic Review ; Journal Article
ZDB-ID	2011956-2
ISSN	1478-5153 ; 1362-1017
ISSN (online)	1478-5153
ISSN	1362-1017
DOI	10.1111/nicc.12687
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Article ; Online: Response to letter "Are we really sure about the pycnogenol antihypertensive effect?"

Malekahmadi, Mahsa / Firouzi, Safieh / Daryabeygi-Khotbehsara, Reza / Islam, Sheikh Mohammed Shariful / Norouzy, Abdolreza / Moradi Moghaddam, Omid / Soltani, Sepideh

Pharmacological research

2019 Volume 151, Page(s) 104544

MeSH term(s)	Antihypertensive Agents ; Cardiovascular Diseases ; Flavonoids ; Humans ; Plant Extracts ; Randomized Controlled Trials as Topic
Chemical Substances	Antihypertensive Agents ; Flavonoids ; Plant Extracts ; pycnogenols (50JZ5Z98QY)
Language	English
Publishing date	2019-11-13
Publishing country	Netherlands
Document type	Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	1003347-6
ISSN	1096-1186 ; 0031-6989 ; 1043-6618
ISSN (online)	1096-1186
ISSN	0031-6989 ; 1043-6618
DOI	10.1016/j.phrs.2019.104544
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Article: Thermal and hydrodynamic properties of coronavirus at various temperature and pressure via molecular dynamics approach.

Malekahmadi, Omid / Zarei, Akbar / Botlani Esfahani, Mohammad Behzad / Hekmatifar, Maboud / Sabetvand, Roozbeh / Marjani, Azam / Bach, Quang-Vu

Journal of thermal analysis and calorimetry

2020 Volume 143, Issue 3, Page(s) 2841–2850

Abstract: COVID-19 is an epidemic virus arising from a freshly discovered coronavirus. Most people involved with the coronavirus will experience slight to moderate respiratory disease and recover without needing particular therapy. In this work, the atomic ... ...

Abstract	COVID-19 is an epidemic virus arising from a freshly discovered coronavirus. Most people involved with the coronavirus will experience slight to moderate respiratory disease and recover without needing particular therapy. In this work, the atomic stability of the coronavirus at different thermodynamic properties such as temperature and pressure, was studied. For this purpose, the manner of this virus by atomic precession was described with a molecular dynamics approach. For the atomic stability of coronavirus description, physical properties such as temperature, total energy, volume variation, and atomic force of this structure were reported. In molecular dynamics approach, coronavirus is precisely simulated via S, O, N, and C atoms and performed Dreiding force field to describe these atoms interaction in the virus. Simulation results show that coronavirus stability has reciprocal relation with atomic temperature and pressure. Numerically, after 2.5 ns simulation, the potential energy varies from - 31,163 to - 26,041 eV by temperature changes from 300 to 400 K. Furthermore, this physical parameter decreases to - 28,045 eV rate at 300 K and 2 bar pressure. The volume of coronavirus is another crucial parameter to the stability description of this structure. The simulation shows that coronavirus volume 92% and 14% increases by 100 K and 2 bar variation of simulation temperature and pressure, respectively.
Language	English
Publishing date	2020-11-21
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2017304-0
ISSN	1572-8943 ; 1588-2926 ; 1388-6150 ; 1418-2874
ISSN (online)	1572-8943 ; 1588-2926
ISSN	1388-6150 ; 1418-2874
DOI	10.1007/s10973-020-10353-2
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Article ; Online: The effect of French maritime pine bark extract supplementation on inflammation, nutritional and clinical status in critically ill patients with traumatic brain injury: A randomized controlled trial.

Malekahmadi, Mahsa / Shadnoush, Mahdi / Islam, Sheikh Mohammed Shariful / Shirvani, Armin / Pahlavani, Naseh / Gholizadeh Navashenaq, Jamshid / Firouzi, Safieh / McVicar, Jenna / Nematy, Mohsen / Zali, Mohammad Reza / Moradi Moghaddam, Omid / Norouzy, Abdolreza

Phytotherapy research : PTR

2021 Volume 35, Issue 9, Page(s) 5178–5188

Abstract: Inflammation plays an important role in the pathophysiology of traumatic brain injury (TBI). Based on the anti-inflammatory properties of French maritime pine bark extract and the neuroprotective effects, we aimed to evaluate the effects of its ... ...

Abstract	Inflammation plays an important role in the pathophysiology of traumatic brain injury (TBI). Based on the anti-inflammatory properties of French maritime pine bark extract and the neuroprotective effects, we aimed to evaluate the effects of its supplementation on TBI. Sixty-seven TBI patients admitted to the intensive care units (ICUs) were enrolled. After stabilizing the hemodynamic status, the intervention group received 150 mg of French maritime pine bark extract supplementation (Oligopin) with enteral nutrition for 10 days. The control group received a placebo. Inflammatory status and oxidative stress markers were measured three times. Also, clinical and nutritional statuses were assessed. Supplementation, significantly decreased IL-6 (β = -53.43 pg/ml, 95% confidence interval [CI] = -91.74, -15.13, p = .006), IL-1β (β = -111.66 pg/ml, 95% CI = -183.79, -39.5402, p = .002) and C-reactive protein (β = -19.99 mg/L, 95% CI = -27.23, -12.76, p ˃ .001) in the intervention group compared to control group after 10 days. Clinical scores including acute physiology and chronic health evaluation II and sequential organ failure assessment were reduced (β = -3.72, 95% CI = -5.96, -1.49, p = .001and β = -2.07, 95% CI = -3.23, -0.90, p < .001, respectively), and Nutric score was reduced compared to control group (β = -.60, 95% CI = -1.08, -0.12, p = .01). The survival rate was higher by 15% in the intervention group compared to control group. Oligopin supplementation in TBI patients in ICU reduced inflammation and improved the clinical status and malnutrition score and thereby reducing the mortality rate.
MeSH term(s)	Brain Injuries, Traumatic/drug therapy ; Critical Illness ; Dietary Supplements ; Flavonoids/therapeutic use ; Humans ; Inflammation/drug therapy ; Nutritional Status ; Pinus/chemistry ; Plant Bark/chemistry ; Plant Extracts/therapeutic use
Chemical Substances	Flavonoids ; Plant Extracts ; pycnogenols (50JZ5Z98QY)
Language	English
Publishing date	2021-08-12
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	639136-9
ISSN	1099-1573 ; 0951-418X
ISSN (online)	1099-1573
ISSN	0951-418X
DOI	10.1002/ptr.7187
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Article ; Online: Effects of pycnogenol on cardiometabolic health: A systematic review and meta-analysis of randomized controlled trials.

Malekahmadi, Mahsa / Moradi Moghaddam, Omid / Firouzi, Safieh / Daryabeygi-Khotbehsara, Reza / Shariful Islam, Sheikh Mohammed / Norouzy, Abdolreza / Soltani, Sepideh

Pharmacological research

2019 Volume 150, Page(s) 104472

Abstract: Aim: Clinical trials on the effect of pycnogenol supplementation on cardiometabolic health have been controversial. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the potential effect of pycnogenol ... ...

Abstract	Aim: Clinical trials on the effect of pycnogenol supplementation on cardiometabolic health have been controversial. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the potential effect of pycnogenol supplementation on cardiometabolic profile. Methods: PubMed, Scopus, and ISI Web of Science databases were searched until October 2018. RCTs that evaluated the effects of pycnogenol on cardiometabolic parameters were included. DerSimonian and Laird random-effect models were used to compute the weighted mean differences (WMDs) and 95% confidence intervals (CIs). Results: Twenty-four RCTs including 1594 participants were included in the meta-analysis. Pycnogenol significantly reduced fasting blood glucose (WMD: -5.86 mg/dl; 95% CI: -9.56, -2.15), glycated hemoglobin (WMD = -0.29%, 95%CI: -0.56, -0.01), systolic blood pressure (WMD: -2.54 mmhg; 95% CI: -4.08, -0.99), diastolic blood pressure (WMD: -1.76 mmhg; 95% CI: -3.12, -0.41), body mass index (WMD: -0.47 kg/m Conclusion: This meta-analysis suggests that pycnogenol may have a role in preventing cardiometabolic disease. However, further well-designed RCTs are recommended to evaluate its long-term effects and explore the optimal duration of use and dosage.
MeSH term(s)	Blood Cell Count ; Blood Glucose/drug effects ; Cardiovascular System/drug effects ; Creatinine/blood ; Dietary Supplements ; Flavonoids/pharmacology ; Free Radicals/blood ; Hemodynamics/drug effects ; Humans ; Lipids/blood ; Liver/drug effects ; Liver/enzymology ; Plant Extracts/pharmacology ; Randomized Controlled Trials as Topic
Chemical Substances	Blood Glucose ; Flavonoids ; Free Radicals ; Lipids ; Plant Extracts ; pycnogenols (50JZ5Z98QY) ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2019-10-01
Publishing country	Netherlands
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	1003347-6
ISSN	1096-1186 ; 0031-6989 ; 1043-6618
ISSN (online)	1096-1186
ISSN	0031-6989 ; 1043-6618
DOI	10.1016/j.phrs.2019.104472
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Article: The effect of French maritime pine bark extract supplementation on inflammation, nutritional and clinical status in critically ill patients with traumatic brain injury: A randomized controlled trial

Phytotherapy research. 2021 Sept., v. 35, no. 9

2021

Abstract: Inflammation plays an important role in the pathophysiology of traumatic brain injury (TBI). Based on the anti‐inflammatory properties of French maritime pine bark extract and the neuroprotective effects, we aimed to evaluate the effects of its ... ...

Abstract	Inflammation plays an important role in the pathophysiology of traumatic brain injury (TBI). Based on the anti‐inflammatory properties of French maritime pine bark extract and the neuroprotective effects, we aimed to evaluate the effects of its supplementation on TBI. Sixty‐seven TBI patients admitted to the intensive care units (ICUs) were enrolled. After stabilizing the hemodynamic status, the intervention group received 150 mg of French maritime pine bark extract supplementation (Oligopin) with enteral nutrition for 10 days. The control group received a placebo. Inflammatory status and oxidative stress markers were measured three times. Also, clinical and nutritional statuses were assessed. Supplementation, significantly decreased IL‐6 (β = −53.43 pg/ml, 95% confidence interval [CI] = −91.74, −15.13, p = .006), IL‐1β (β = −111.66 pg/ml, 95% CI = −183.79, −39.5402, p = .002) and C‐reactive protein (β = −19.99 mg/L, 95% CI = −27.23, −12.76, p ˃ .001) in the intervention group compared to control group after 10 days. Clinical scores including acute physiology and chronic health evaluation II and sequential organ failure assessment were reduced (β = −3.72, 95% CI = −5.96, −1.49, p = .001and β = −2.07, 95% CI = −3.23, −0.90, p < .001, respectively), and Nutric score was reduced compared to control group (β = −.60, 95% CI = −1.08, −0.12, p = .01). The survival rate was higher by 15% in the intervention group compared to control group. Oligopin supplementation in TBI patients in ICU reduced inflammation and improved the clinical status and malnutrition score and thereby reducing the mortality rate.
Keywords	C-reactive protein ; Pinus pinaster ; bark extracts ; brain damage ; confidence interval ; enteral feeding ; health status ; hemodynamics ; inflammation ; interleukin-6 ; malnutrition ; oxidative stress ; pathophysiology ; phytotherapy ; placebos ; randomized clinical trials ; research ; survival rate
Language	English
Dates of publication	2021-09
Size	p. 5178-5188.
Publishing place	John Wiley & Sons, Ltd.
Document type	Article
Note	JOURNAL ARTICLE
ZDB-ID	639136-9
ISSN	1099-1573 ; 0951-418X
ISSN (online)	1099-1573
ISSN	0951-418X
DOI	10.1002/ptr.7187
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Article ; Online: Effects of Melatonin and Propolis Supplementation on Inflammation, Oxidative Stress, and Clinical Outcomes in Patients with Primary Pneumosepsis: A Randomized Controlled Clinical Trial.

Pahlavani, Naseh / Malekahmadi, Mahsa / Sedaghat, Alireza / Rostami, Amirabbas / Alkadir, Ola Kamal A / Taifi, Ahmed / Ranjbar, Golnaz / Sahebkar, AmirHossein / Abdelbasset, Walid Kamal / Beigmohammadi, Mohammad Taghi / Mir, Mahdieh / Bagheri Moghaddam, Ahmad / Tabesh, Hamed / Sadeghi, Omid / Gholizadeh Navashenaq, Jamshid / Firouzi, Safieh / Fathi Najafi, Mohsen / Safarian, Mohammad / Ghayour-Mobarhan, Majid

Complementary medicine research

2022 Volume 29, Issue 4, Page(s) 275–285

Abstract: Background and objective: The present study aimed to investigate the effects of propolis and melatonin supplementation on inflammation, clinical outcomes, and oxidative stress markers in patients with primary pneumosepsis.: Materials and methods: ... ...

Title translation	Auswirkungen der Melatonin- und Propolis-Supplementierung auf das Entzündungsgeschehen, den oxidativen Stress und die klinischen Ergebnisse bei Patienten mit primärer Pneumosepsis: Eine randomisierte kontrollierte klinische Studie.
Abstract	Background and objective: The present study aimed to investigate the effects of propolis and melatonin supplementation on inflammation, clinical outcomes, and oxidative stress markers in patients with primary pneumosepsis. Materials and methods: This pilot randomized controlled trial was conducted on 55 patients with primary pneumosepsis who were randomly assigned to the intervention and control groups. In the three intervention groups, the patients received propolis alone (1,000 mg/day), propolis (1,000 mg/day) plus melatonin (20 mg/day), and melatonin alone (20 mg/day). The control group received placebo. The inflammatory and oxidative stress markers as well as clinical outcomes were evaluated before and after the intervention, and the 28-day survival rate was also recorded. Results: After the intervention, the combination of propolis and melatonin significantly reduced interleukin-6 (-55.282 pg/mL) and C-reactive protein (-21.656 mg/L) levels, while increasing gavage intake (326.680 mL/day) and improving some clinical outcomes (APACHE II, SOFA, and NUTRIC scores) compared to the control group. However, no significant difference was observed between the groups in terms of oxidative stress and hematological indices. In addition, there was no significant difference in the 28-day survival rate between the groups (p = 0.07). Conclusion: Supplementation with propolis and melatonin may improve clinical outcomes by reducing inflammation. Further investigations are required to confirm these findings.
MeSH term(s)	Biomarkers ; Dietary Supplements ; Double-Blind Method ; Humans ; Inflammation/chemically induced ; Inflammation/drug therapy ; Melatonin/pharmacology ; Melatonin/therapeutic use ; Oxidative Stress ; Propolis/pharmacology ; Propolis/therapeutic use
Chemical Substances	Biomarkers ; Propolis (9009-62-5) ; Melatonin (JL5DK93RCL)
Language	English
Publishing date	2022-02-25
Publishing country	Switzerland
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2885931-5
ISSN	2504-2106 ; 2504-2092
ISSN (online)	2504-2106
ISSN	2504-2092
DOI	10.1159/000523766
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Article ; Online: 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 / Islam, Sheikh Mohammed Shariful / Tanha, Kiarash / Nematy, Mohsen / Pahlavani, Naseh / Firouzi, Safieh / Zali, Mohammad Reza / Norouzy, Abdolreza

Trials

2020 Volume 21, Issue 1, Page(s) 162

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 patients. One of the ingredients that can be used ...

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 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. Trial registration: This trial is registered at clinicaltrials.gov (ref: NCT03777683) at 12/13/2018.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antioxidants/administration & dosage ; Antioxidants/adverse effects ; Biomarkers/blood ; Brain Injuries, Traumatic/blood ; Brain Injuries, Traumatic/diagnosis ; Brain Injuries, Traumatic/diet therapy ; Brain Injuries, Traumatic/immunology ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Dietary Supplements/adverse effects ; Double-Blind Method ; Female ; Flavonoids/administration & dosage ; Flavonoids/adverse effects ; Humans ; Intensive Care Units/statistics & numerical data ; Male ; Middle Aged ; Nutritional Status/drug effects ; Oxidative Stress/drug effects ; Oxidative Stress/immunology ; Plant Extracts/administration & dosage ; Plant Extracts/adverse effects ; Randomized Controlled Trials as Topic ; Severity of Illness Index ; Treatment Outcome ; Young Adult
Chemical Substances	Antioxidants ; Biomarkers ; Flavonoids ; Plant Extracts ; pycnogenols (50JZ5Z98QY)
Keywords	covid19
Language	English
Publishing date	2020-02-11
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-019-4008-x
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Article ; Online: 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

Mahsa Malekahmadi / Omid Moradi Moghaddam / Sheikh Mohammed Shariful Islam / Kiarash Tanha / Mohsen Nematy / Naseh Pahlavani / Safieh Firouzi / Mohammad Reza Zali / Abdolreza Norouzy

Trials, Vol 21, Iss 1, Pp 1-

A randomized clinical trial protocol

2020 Volume 9

Abstract: 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 patients. One of the ingredients that can ... ...

Abstract	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 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. Trial registration This trial is registered at clinicaltrials.gov (ref: NCT03777683) at 12/13/2018.
Keywords	Traumatic brain injury ; Critical care ; Pycnogenol ; Inflammation ; Nutrition support ; French maritime pine bark extract ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2020-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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