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Clinical nutrition

The efficacy of flaxseed and hesperidin on non-alcoholic fatty liver disease: an open-labeled randomized controlled trial

European Journal of Clinical Nutrition volume 75, pages 99–111 (2021)Cite this article

Subjects

Abstract

Background/Objectives

Non-alcoholic fatty liver disease (NAFLD) is growing in prevalence globally and no definitive evidence for any approved pharmacological approaches for patients with NAFLD has been found yet. This study was aimed to assess the clinical effects of flaxseed and hesperidin in patients with NAFLD.

Subjects/methods

In this randomized, controlled, clinical trial, one hundred eligible patients with NAFLD were enrolled and randomly assigned to four dietary intervention groups including lifestyle modification program (control), lifestyle modification program with 30 g whole flaxseed powder, lifestyle modification program with 1 g hesperidin supplementation, and lifestyle modification program with combination of 30 g flaxseed and 1 g hesperidin (flax-hes) for 12 weeks. The changes in anthropometric parameters, metabolic profiles of glucose and lipids, inflammatory biomarkers and hepatic steatosis and fibrosis were evaluated.

Results

After the 12-week dietary interventions, significant reductions in body mass index, glucose hemostasis parameters and hepatic steatosis were observed in all groups. Repeated measures analysis of variance revealed a significant effect for time relative to almost all paraclinical parameters. Post hoc analysis with Bonferroni correction revealed that the three intervention groups experienced significant decreases in plasma levels of alanine aminotransferase, indices of insulin resistance and insulin sensitivity, fasting glucose and fatty liver index compared to control (p < 0.008).

Conclusions

In conclusion, our study confirmed that hesperidin and flaxseed supplementation improved glucose and lipid metabolism, while reduced inflammation and hepatic steatosis (controlled attenuation parameter) in NAFLD patients. The synergistic effects of their combination were observed on plasma glucose concentration and HOMA-IR.

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Fig. 1: The study consort flowchart.
Fig. 2: Comparison of steatosis percent reduction (%) across all groups at different degrees of body weight change (<5%, 5–10% and ≥10% body weight change).
Fig. 3: Box plot of the fasting glucose; insulin and HOMA-IR at baseline (T0) and at the end of trial (T12), among four groups, with a significant improvement in all groups over the intervention (p < 0.05).

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Acknowledgements

We acknowledge all patients who accepted to participate in this study.

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Authors and Affiliations

  1. Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Zahra Yari & Azita Hekmatdoost

  2. Cancer Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Makan Cheraghpour

  3. Middle East Liver Diseases (MELD) Center, Tehran, Iran

    Seyed Moayed Alavian

  4. Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Mehdi Hedayati

  5. Department of Community Nutrition, National Nutrition and Food Technology Research Institute; and Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Hassan Eini-Zinab

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  1. Zahra Yari
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Contributions

ZY was responsible for conceptualization and designing the study, recruiting and following patients, writing the manuscript. MC was responsible for conceptualization and designing the study, providing supplements and commercial kits, reviewing the manuscript. SMA was responsible forassessing liver steatosis using a transient elastography (FibroScan). MH was responsible for biochemical evaluations in samples collected, using the relative kits, according to the manufacturer’s instructions. HEZ was responsible for statistical analyzing. AH was responsible for conceptualization and designing the study, project administration, writing, review and editing the manuscript.

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Correspondence to Makan Cheraghpour or Azita Hekmatdoost.

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Yari, Z., Cheraghpour, M., Alavian, S.M. et al. The efficacy of flaxseed and hesperidin on non-alcoholic fatty liver disease: an open-labeled randomized controlled trial. Eur J Clin Nutr 75, 99–111 (2021). https://doi.org/10.1038/s41430-020-0679-3

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