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

Autor:	Hegazi OE; Center of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab Emirates.; Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates., Alalalmeh SO; Center of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab Emirates.; Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates., Alnuaimi GRH; Center of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab Emirates.; Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates., Shahwan M; Center of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab Emirates.; Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab Emirates., Jairoun AA; Health and Safety Department, Dubai Municipality, Dubai, United Arab Emirates.; School of Pharmaceutical Sciences, University Sains Malaysia (USM), Pulau Pinang, Malaysia., Alorfi NM; Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia., Majrashi SA; Department of Laparoscopic Surgery, King Fahad Hospital, Ministry of Health, Jeddah, Saudi Arabia., Alkhanani MF; Biology Department, College of Sciences, University of Hafr Al Batin, Hafr Al Batin, Saudi Arabia., Alkhattabi A; Department of Gastroenterology, East Jeddah Hospital, Jeddah, Saudi Arabia., Alourfi MM; Department of Gastroenterology, East Jeddah Hospital, Jeddah, Saudi Arabia.; Internal Medicine Department, King Faisal Medical City for Southern Region, Abha, Saudi Arabia., Alsolami FA; Khulais General Hospital, Makkah cluster, Ministry of Health, Makkah, Saudi Arabia., Alsharif S; Gastroenterology Department, Armed force hospital of Southern region, Khamis Mushait, Saudi Arabia., Alshahrani H; Internal medicine Department, Khamis Mushait General hospital, Khamis Mushait, Saudi Arabia.
Jazyk:	angličtina
Zdroj:	Frontiers in medicine [Front Med (Lausanne)] 2023 Aug 01; Vol. 10, pp. 1227046. Date of Electronic Publication: 2023 Aug 01 (Print Publication: 2023).
DOI:	10.3389/fmed.2023.1227046
Abstrakt:	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. Competing Interests: 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. (Copyright © 2023 Hegazi, Alalalmeh, Alnuaimi, Shahwan, Jairoun, Alorfi, Majrashi, Alkhanani, Alkhattabi and Alourfi, Alsolami, Alsharif and Alshahrani.)
Databáze:	MEDLINE
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