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NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials
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...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10433184/ https://www.ncbi.nlm.nih.gov/pubmed/37601777 http://dx.doi.org/10.3389/fmed.2023.1227046 |
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author | Hegazi, Omar E. Alalalmeh, Samer O. Alnuaimi, Ghala Rashid Humaid Shahwan, Moyad Jairoun, Ammar Abdulrahman Alorfi, Nasser M. Majrashi, Shaker A. Alkhanani, Mustfa Faisal Alkhattabi, Abdullah Alourfi, Mansour M. Alsolami, Faris A. Alsharif, Saeed Alshahrani, Hatim |
author_facet | Hegazi, Omar E. Alalalmeh, Samer O. Alnuaimi, Ghala Rashid Humaid Shahwan, Moyad Jairoun, Ammar Abdulrahman Alorfi, Nasser M. Majrashi, Shaker A. Alkhanani, Mustfa Faisal Alkhattabi, Abdullah Alourfi, Mansour M. Alsolami, Faris A. Alsharif, Saeed Alshahrani, Hatim |
author_sort | Hegazi, Omar E. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10433184 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-104331842023-08-18 NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials Hegazi, Omar E. Alalalmeh, Samer O. Alnuaimi, Ghala Rashid Humaid Shahwan, Moyad Jairoun, Ammar Abdulrahman Alorfi, Nasser M. Majrashi, Shaker A. Alkhanani, Mustfa Faisal Alkhattabi, Abdullah Alourfi, Mansour M. Alsolami, Faris A. Alsharif, Saeed Alshahrani, Hatim Front Med (Lausanne) Medicine 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. Frontiers Media S.A. 2023-08-01 /pmc/articles/PMC10433184/ /pubmed/37601777 http://dx.doi.org/10.3389/fmed.2023.1227046 Text en Copyright © 2023 Hegazi, Alalalmeh, Alnuaimi, Shahwan, Jairoun, Alorfi, Majrashi, Alkhanani, Alkhattabi and Alourfi, Alsolami, Alsharif and Alshahrani. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Medicine Hegazi, Omar E. Alalalmeh, Samer O. Alnuaimi, Ghala Rashid Humaid Shahwan, Moyad Jairoun, Ammar Abdulrahman Alorfi, Nasser M. Majrashi, Shaker A. Alkhanani, Mustfa Faisal Alkhattabi, Abdullah Alourfi, Mansour M. Alsolami, Faris A. Alsharif, Saeed Alshahrani, Hatim NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials |
title | NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials |
title_full | NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials |
title_fullStr | NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials |
title_full_unstemmed | NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials |
title_short | NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials |
title_sort | nafld and nutraceuticals: a review of completed phase iii and iv clinical trials |
topic | Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10433184/ https://www.ncbi.nlm.nih.gov/pubmed/37601777 http://dx.doi.org/10.3389/fmed.2023.1227046 |
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