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Efficacy of nanocurcumin supplementation on insulin resistance, lipids, inflammatory factors and nesfatin among obese patients with non-alcoholic fatty liver disease (NAFLD): a trial protocol

Abstract

Objectives Different studies have been conducted on the role of curcumin in health since having multiple properties, including antioxidant and anti-inflammatory effects. Due to the lack of studies regarding curcumin effects on obese patients with non-alcoholic fatty liver disease (NAFLD), our protocol was designed to assess nanocurcumin impacts on blood sugar, lipids, inflammatory indices, insulin resistance and liver function, especially by nesfatin.

Setting This trial will be conducted in the Oil Company central hospital of Tehran, Iran with a primary level of care.

Participants 84 obese patients with NAFLD diagnosed using ultrasonography will be employed according to the eligibility criteria‎.

Interventions The patients will be randomly divided into two equal groups (nanocurcumin and placebo, two 40 mg capsules per day with meals for 3 months, follow-up monthly). Also, lifestyle changes (low-calorie diet and physical activity) will be advised.

Measures of the primary and secondary outcomes A general questionnaire, 24 hours food recall (at the beginning, middle and end) and short-form International Physical Activity Questionnaire will be completed. Blood pressure, anthropometrics, serum sugar indices (fasting blood sugar and insulin, insulin resistance and sensitivity and glycosylated haemoglobin), lipids (triglyceride, total cholesterol and low-density and high-density lipoprotein-cholesterol, inflammatory profiles (interleukin-6, high-sensitivity C-reactive protein, and tumour necrosis factor-alpha), liver function (alanine and aspartate transaminase) and nesfatin will be measured at the beginning and end of the study.

Conclusion This trial would be the first experiment to determine nanocurcumin efficacy on certain blood factors among obese patients with NAFLD. Nevertheless, studying the potential consequences of curcumin in various diseases, especially NAFLD, is required for clinical use.

Trial registration number IRCT2016071915536N3; pre-results.

  • Nanocurcumin
  • Non-Alcoholic Fatty Liver Disease
  • Trial Protocol
  • Overweight
  • Obesity

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors SAJT, MJHA and SMR conceived and developed the idea for the study and revised the manuscript. SM, SMA and MDM contributed to data collection. MDM wrote numerous drafts of the study. MQ contributed to statistical interpretations. All authors read and approved the final manuscript.

  • Funding The trial funding was supported by Tehran University of Medical Sciences.

  • Competing interests None declared.

  • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

  • Ethics approval The ethical approval of this trial was conducted by the ethics committee of Tehran University of Medical Sciences (Ethical Code: IR.TUMS.REC.1395.2612). All the participants will complete an informed consent form (in Persian). Participation in and continuation of the supplementation is free and voluntary for the patients. In the trial, advice on the lifestyle modification will be presented to the patients free of charge. The health care services of the hospital will be provided without inconsistency. The side effects of the supplements had not been previously published. The patients' personal information will be kept confidential.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement There are no additional data to share.

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