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Review
. 2023 Aug 1:10:1227046.
doi: 10.3389/fmed.2023.1227046. eCollection 2023.

NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials

Omar E Hegazi  1   2 , Samer O Alalalmeh  1   2 , Ghala Rashid Humaid Alnuaimi  1   2 , Moyad Shahwan  1   2 , Ammar Abdulrahman Jairoun  3   4 , Nasser M Alorfi  5 , Shaker A Majrashi  6 , Mustfa Faisal Alkhanani  7 , Abdullah Alkhattabi  8 , Mansour M Alourfi  8   9 , Faris A Alsolami  10 , Saeed Alsharif  11 , Hatim Alshahrani  12
Affiliations
Review

NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials

Omar E Hegazi et al. Front Med (Lausanne). .

Abstract

Background: Nonalcoholic Fatty Liver Disease (NAFLD) has become a significant public health concern, affecting approximately one-fourth of the population. Despite its prevalence, no FDA-approved drug treatments specifically target NAFLD.

Aim: To provide a review of clinical trials investigating the use of herbal remedies and dietary supplements in NAFLD management, utilizing the ClinicalTrials.gov database.

Methods: This review evaluates the current evidence by examining completed phase III and IV clinical trials registered on ClinicalTrials.gov. An exhaustive search was performed on April 17, 2023, using the terms "Nonalcoholic Fatty Liver Disease" and "NAFLD." Two independent reviewers appraised eligible trials based on pre-defined inclusion and exclusion criteria.

Results: An initial search yielded 1,226 clinical trials, with 12 meeting the inclusion criteria after filtration. The majority of trials focused on Omega-3 fatty acids (20.0%) and vitamin D (26.7%), followed by caffeine, chlorogenic acid, ginger, phosphatidylcholine, Trigonella Foenum-graecum seed extract, vitamin C, and vitamin E (each 6.7%). Most studies were Phase 3 (75.0%) and used a parallel assignment model (91.7%). Quadruple masking was the most prevalent technique (58.3%), and Iran was the leading country in terms of trial locations (25.0%). These interventions constitute two herbal interventions and nine supplement interventions.

Conclusion: This reveals a diverse range of nutraceuticals, with Omega-3 fatty acids and vitamin D being predominant in the management of NAFLD. The global distribution of trials highlights the widespread interest in these therapeutics. However, more rigorous, large-scale trials are needed to establish safety, efficacy, and optimal dosages.

Keywords: NAFLD; Omega-3 fatty acids; dietary supplements; nutraceuticals; vitamins.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram.
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References

    1. Hammam OA, Seif el Din SH, El-Lakkany NM, El-Naggar AA, Abd El--Latif HA, Ain-Shoka AA, et al. . P0976: effect of rosuvastatin or/and β-carotene and dietary control on non-alcoholic fatty liver disease (NAFLD) in rats. J Hepatol. (2015) 62:S712. doi: 10.1016/s0168-8278(15)31177-6 - DOI - PubMed
    1. Khayyat YM. Determination of “indeterminate score” measurements in lean nonalcoholic fatty liver disease patients from western Saudi Arabia. World J Hepatol. (2021) 13:2150–60. doi: 10.4254/wjh.v13.i12.2150, PMID: - DOI - PMC - PubMed
    1. Younossi Z. M., Golabi P., Paik J. M., Henry A., Dongen C., Henry L. (2023). The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology 77, 1335–1347. doi: 10.1097/HEP.0000000000000004, PMID: - DOI - PMC - PubMed
    1. Pan HJ, Chang HT, Lee CH. Association between tamoxifen treatment and the development of different stages of nonalcoholic fatty liver disease among breast cancer patients. J Formos Med Assoc. (2016) 115:411–7. doi: 10.1016/J.JFMA.2015.05.006, PMID: - DOI - PubMed
    1. Pouwels S, Sakran N, Graham Y, Leal A, Pintar T, Yang W, et al. . Non-alcoholic fatty liver disease (NAFLD): a review of pathophysiology, clinical management and effects of weight loss. BMC Endocr Disord. (2022) 22:1–9. doi: 10.1186/S12902-022-00980-1/FIGURES/1 - DOI - PMC - PubMed