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The effect of Ellagic acid on sleep quality in patients with type 2 diabetes: a randomized double blind clinical trial

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International Journal of Diabetes in Developing Countries Aims and scope Submit manuscript

Abstract

Background

Oxidative stress can reduce the quality of sleep in patients with type 2 diabetes. Antioxidants such as polyphenols may increase sleep quality by improving oxidative stress conditions.

Objective

Considering the antioxidant properties of Ellagic acid (EA), this study was designed to evaluate the effect of EA on sleep quality in diabetic patients.

Methods

In this study, 44 diabetic patients were recruited. Patients who met the inclusion criteria that were randomly allocated consumed a capsule containing 180 mg of EA per day (n = 22) or placebo (n = 22) for 8 weeks. Anthropometric factors, physical activity, food intake, and Petersburg’s Sleep Quality (PSQI) questionnaire were assessed at the beginning and end of the study. Kolmogorov-Smirnov test, paired sample t test and independent sample t test were used to analyze the data.

Results

At the end of the study, the mean scores of PSQI and sleep subgroups in the intervention group were significantly lower than in the placebo group (p < 0.05). According to intragroup comparisons, these changes were significant in the intervention group at the end of the study compared to the beginning of the study (p < 0.05) and were not significant in the placebo group (p > 0.05).

Conclusion

According to these findings, intake of EA may help to improve the sleep quality in patients with type 2 diabetes. These effects may be due to the antioxidant effects of this polyphenol.

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Data availability

Data from this project will not be shared because additional results from the study are yet to be published.

Abbreviations

AGEs:

Advanced glycation end products

BMI:

Body mass index

DM:

Diabetes mellitus

EA:

Ellagic acid

FBS:

Fasting blood sugar

GPx:

Glutathione peroxidase

GSH:

Glutathione

GSSG:

Oxidized glutathione

HbA1c:

Hemoglobin A1c

IL-1:

Interleukin-1

IPAQ:

International Physical Activity Questionnaire

MDA:

Malondialdehyde

PSQI:

Petersburg’s Sleep Quality Index

ROS:

Reactive oxygen species

SOD:

Superoxide dismutase

TNFα:

Tumor necrosis factor alpha

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Acknowledgments

The authors would like to thank all of the participants who completed the study protocol. This work was financially supported by a Grant (Number: IR.QUMS.REC.1398.079) from Vice-Chancellor for Research Affairs of Qazvin University of Medical Sciences, Qazvin, Iran.

Authors’ details

MG: MSc, Department of Nutrition, School of Health, Qazvin University of Medical Sciences.

SH: Department of Internal Medicine, Velayat Clinical Research Development Unit, Qazvin University of Medical Sciences.

MRN: Department of Pharmacology and Toxicology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences.

MK: Department of Tissue Engineering and Applied Cell Sciences, Faculty of Advanced Technologies in Medicine, Tehran University of Medical Sciences.

HKH: Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences.

Funding

This work was financially supported by a Grant (Number: IR.QUMS.REC.1398.079) from Vice-Chancellor for Research Affairs of Qazvin University of Medical Sciences, Qazvin, Iran. This investigation was extracted from the Master of Science thesis of Zahra Mirzaie, student of Qazvin University of Medical Sciences.

Author information

Author notes

  1. Maria Kavianpour and Hossein Khadem Haghighian contributed equally to this work.

Authors and Affiliations

  1. Department of Nutrition, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran

    Mahnaz Ghadimi & Hossein Khadem Haghighian

  2. Department of Internal Medicine, Velayat Clinical Research Development Unit, Qazvin University of Medical Sciences, Qazvin, Iran

    Sima Hashemipour

  3. Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran

    Sima Hashemipour & Hossein Khadem Haghighian

  4. Department of Pharmacology and Toxicology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Mohamadreza Rashidi Nooshabadi

  5. Department of Tissue Engineering and Applied Cell Sciences, Faculty of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran

    Maria Kavianpour

Authors
  1. Mahnaz Ghadimi
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  4. Maria Kavianpour
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Contributions

All persons who met authorship criteria are listed as authors. M Ghadimi, M Kavianpour, and H Khadem Haghighian contributed significantly to the work’s conception, participated in the writing and critical revision of the manuscript in a manner sufficient to establish the ownership of the intellectual content. S Hashemipour and M Rashidi Nooshabadi contributed significantly to the work’s conception. H Khadem Haghighian analyzed and interpreted data. M Ghadimi and M Kavianpour involved in the design of work. All authors approved the final version of the manuscript to be published.

Corresponding authors

Correspondence to Maria Kavianpour or Hossein Khadem Haghighian.

Ethics declarations

Ethics

The study was approved by the Ethical Committee of Qazvin University of Medical Sciences with grant number of IR.QUMS.REC.1398.079 and also registered by the identification code IRCT20141025019669N13 in clinical trial registry of Iran. Informed consent was obtained from these individuals to participate in the study.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval and consent to participate

The protocol of the study after approving with the ethic committee of Qazvin University of Medical Sciences, Qazvin, Iran, with grant number of Number: IR.QUMS.REC.1398.079, was registered in the Iranian Registry of Clinical Trials website by the IRCT20141025019669N13 code. Also, written informed consent was given by all the participants before their inclusion in the study.

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Ghadimi, M., Hashemipour, S., Nooshabadi, M.R. et al. The effect of Ellagic acid on sleep quality in patients with type 2 diabetes: a randomized double blind clinical trial. Int J Diabetes Dev Ctries 41, 29–36 (2021). https://doi.org/10.1007/s13410-020-00849-w

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  • DOI: https://doi.org/10.1007/s13410-020-00849-w

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