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Therapeutic effects of supplementation with Curcuminoids in critically ill patients receiving enteral nutrition: a randomized controlled trial protocol

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Abstract

Background

Curcuminoids are dietary polyphenols that can improve health indices through different mechanisms such as anti-inflammatory, antioxidant and immunoregulatory properties. Due to the lack of evidences on the efficacy of curcuminoids in critically ill patients, this study was designed to investigate the effects of short-term curcuminoids supplementation on inflammatory, oxidative stress and adipokine indices as well as nutritional and clinical status in Traumatic Brain Injury (TBI) patients admitted in the Intensive Care Unit (ICU).

Methods

The present trial will be performed in the ICU of Sina and Shohadaye Tajrish hospitals of Tehran, Iran. Sixty-two critically ill patients with TBI will be enrolled based on the eligibility criteria. The patients will be randomly assigned into two groups. For 7 days, they will received either 500 mg curcuminoids in combination with 5 mg piperine or matched placebo. A general questionnaire, consent form as well as NUTRIC, SOFA and APACHEII scoring system and anthropometrics will be assessed at baseline. The inflammatory markers including TNF-α, IL-6, MCP-1 and CRP, oxidative stress indices (GPx and SOD) and adipokines (leptin and adiponetctin) will be measured at baseline and at the end of the study. In addition, dietary intake, concomitant drugs and laboratory tests will be recorded daily.

Discussion

To the best of our knowledge, this is the first clinical trial investigating the effect of curcuminoids supplementation in critically ill patient with TBI. The findings of the present study will provide evidence on the efficacy and safety of curcuminoids in these patients.

Trial registration number

(http://www.irct.ir, identifier: IRCT20180619040151N1), Registration date:18.09.2018.

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Abbreviations

TBI:

Traumatic brain injury

ICU:

Intensive care unit

TNF-α:

Necrosis factor-α

IL-6:

Interleukine-6

MCP-1:

Monocyte chemoattractant protein-1

CRP:

C-reactive protein

APACHEII:

Acute physiology and chronic health evaluation II

SOFA:

Sequential organ failure assessment

NUTRIC:

Nutrition risk in the criticallay ill

SDH:

Acute subdural hematoma

ICH:

Intracranial hemorrhage

DAI:

Diffuse axonal injury

NF- kB:

Nuclear factor-kappa B

Nrf2:

Nuclear factor erythroid 2-related factor 2

GPx:

Gluthation peroxidase

SOD:

Superoxide dismutase

GCS:

Glascow coma score

BMI:

Body mass index

GRAS:

Generally recognized as safe

FDA:

Food and Drug Adminstration

ELISA:

Enzymed-linked immunosorbent Assay

ANOVA:

Analysis of variance (ANOVA).

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Acknowledgements

The support of Tehran University of Medical Sciences and Semnan University of Medical Sciences and Health Services and cooperation of the Sina and Shohadaye Tajrish hospitals as well as patient advisers are acknowledged.

Funding

The present research has been supported by Tehran University of Medical Sciences and Semnan University of Medical sciences and Health Services grant no. 96–04–161-37823.

Author information

Authors and Affiliations

  1. Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, No.44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran

    Hoda Zahedi, Mohammad-Javad Hosseinzadeh-Attar, Saeed Hosseini & Abdolreza Norouzy

  2. Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran

    Amirhossein Sahebkar

  3. Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

    Amirhossein Sahebkar

  4. School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran

    Amirhossein Sahebkar

  5. Obesity and Eating Habits Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran

    Shirin Hasani Ranjbar

  6. Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Thran University of Medical Sciences, Tehran, Iran

    Shirin Hasani Ranjbar

  7. Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran

    Atabak Najafi & Arezoo Ahmadi

  8. Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran

    Mostafa Qorbani

  9. Department of Anesthesiology and Critical Care, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Seyed Hossein Ardehali

  10. Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Hamideh Moravvej

  11. Urology Research Center, Tehran University of Medical Sciences, Tehran, Iran

    Gholamreza Pourmand

  12. Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Iran

    Mahdi Shadnoush

  13. Department of Clinical Nutrition, Faculty of Nutrition & Food Technology, Shahid Beheshti University of Medical Sciences, Velenjak Street, Shahid Chamran High Way, Tehran, Iran

    Mahdi Shadnoush

Authors
  1. Hoda Zahedi
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  2. Mohammad-Javad Hosseinzadeh-Attar
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  3. Amirhossein Sahebkar
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  4. Shirin Hasani Ranjbar
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  5. Atabak Najafi
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  6. Saeed Hosseini
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  7. Mostafa Qorbani
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  8. Arezoo Ahmadi
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  9. Seyed Hossein Ardehali
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  10. Hamideh Moravvej
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  11. Gholamreza Pourmand
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  12. Abdolreza Norouzy
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  13. Mahdi Shadnoush
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Contributions

Ablodreza Norouzy cooperated on the initial study concept and design of this research, which was further developed by Mahdi Shadnoush and Mohammad-Javad Hosseinzadeh-Attar. Saeed Hoseeini revised the study. Mostafa Qorbani advised on statistical analysis and interpretation of data. Atabak Najafi, Arezoo Ahmadi and Seyed-Hoseein Ardehali coordinated participant management and data collection and relevant questionnairs. Hoda Zahedi and Amirhossein Sahebkar took part in drafting the manuscript and technical or material support. Hamideh Moravvej and Gholamreza Pourmand will corporate in laboratory activities. The manuscript has been read and approved by all authors.

Corresponding authors

Correspondence to Abdolreza Norouzy or Mahdi Shadnoush.

Ethics declarations

Ethics approval and consent to participate

The Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1397.141) and Semnan University of Medical Sciences and Health Services (IR.SEMUMS.REC.1397.001) has approved the protocol of this study. A written informed consent form will be signed and dated by subjects or their legal guardians and investigators at the beginning of the study.

Conflict of interests

The authors declared that they have no competing interests.

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Zahedi, H., Hosseinzadeh-Attar, MJ., Sahebkar, A. et al. Therapeutic effects of supplementation with Curcuminoids in critically ill patients receiving enteral nutrition: a randomized controlled trial protocol. J Diabetes Metab Disord 19, 1609–1614 (2020). https://doi.org/10.1007/s40200-019-00451-w

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  • DOI: https://doi.org/10.1007/s40200-019-00451-w

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