NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials
BackgroundNonalcoholic 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.AimTo provide a review of clinical trials investigating the use o...
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Frontiers Media S.A.
2023-08-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1227046/full |
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| author | Omar E. Hegazi Omar E. Hegazi Samer O. Alalalmeh Samer O. Alalalmeh Ghala Rashid Humaid Alnuaimi Ghala Rashid Humaid Alnuaimi Moyad Shahwan Moyad Shahwan Ammar Abdulrahman Jairoun Ammar Abdulrahman Jairoun Nasser M. Alorfi Shaker A. Majrashi Mustfa Faisal Alkhanani Abdullah Alkhattabi Mansour M. Alourfi Mansour M. Alourfi Faris A. Alsolami Saeed Alsharif Hatim Alshahrani |
| author_facet | Omar E. Hegazi Omar E. Hegazi Samer O. Alalalmeh Samer O. Alalalmeh Ghala Rashid Humaid Alnuaimi Ghala Rashid Humaid Alnuaimi Moyad Shahwan Moyad Shahwan Ammar Abdulrahman Jairoun Ammar Abdulrahman Jairoun Nasser M. Alorfi Shaker A. Majrashi Mustfa Faisal Alkhanani Abdullah Alkhattabi Mansour M. Alourfi Mansour M. Alourfi Faris A. Alsolami Saeed Alsharif Hatim Alshahrani |
| author_sort | Omar E. Hegazi |
| collection | DOAJ |
| description | BackgroundNonalcoholic 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.AimTo provide a review of clinical trials investigating the use of herbal remedies and dietary supplements in NAFLD management, utilizing the ClinicalTrials.gov database.MethodsThis 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.ResultsAn 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.ConclusionThis 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. |
| first_indexed | 2024-03-12T20:33:27Z |
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| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-03-12T20:33:27Z |
| publishDate | 2023-08-01 |
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| spelling | doaj.art-9abbf0ecf1914fb88c822d8ec850fce22023-08-01T17:41:23ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-08-011010.3389/fmed.2023.12270461227046NAFLD and nutraceuticals: a review of completed phase III and IV clinical trialsOmar E. Hegazi0Omar E. Hegazi1Samer O. Alalalmeh2Samer O. Alalalmeh3Ghala Rashid Humaid Alnuaimi4Ghala Rashid Humaid Alnuaimi5Moyad Shahwan6Moyad Shahwan7Ammar Abdulrahman Jairoun8Ammar Abdulrahman Jairoun9Nasser M. Alorfi10Shaker A. Majrashi11Mustfa Faisal Alkhanani12Abdullah Alkhattabi13Mansour M. Alourfi14Mansour M. Alourfi15Faris A. Alsolami16Saeed Alsharif17Hatim Alshahrani18Center of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab EmiratesDepartment of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab EmiratesCenter of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab EmiratesDepartment of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab EmiratesCenter of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab EmiratesDepartment of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab EmiratesCenter of Medical and Bio-Allied Health Sciences Research, Ajman University, Ajman, United Arab EmiratesDepartment of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, United Arab EmiratesHealth and Safety Department, Dubai Municipality, Dubai, United Arab EmiratesSchool of Pharmaceutical Sciences, University Sains Malaysia (USM), Pulau Pinang, MalaysiaDepartment of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi ArabiaDepartment of Laparoscopic Surgery, King Fahad Hospital, Ministry of Health, Jeddah, Saudi ArabiaBiology Department, College of Sciences, University of Hafr Al Batin, Hafr Al Batin, Saudi ArabiaDepartment of Gastroenterology, East Jeddah Hospital, Jeddah, Saudi ArabiaDepartment of Gastroenterology, East Jeddah Hospital, Jeddah, Saudi ArabiaInternal Medicine Department, King Faisal Medical City for Southern Region, Abha, Saudi Arabia0Khulais General Hospital, Makkah cluster, Ministry of Health, Makkah, Saudi Arabia1Gastroenterology Department, Armed force hospital of Southern region, Khamis Mushait, Saudi Arabia2Internal medicine Department, Khamis Mushait General hospital, Khamis Mushait, Saudi ArabiaBackgroundNonalcoholic 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.AimTo provide a review of clinical trials investigating the use of herbal remedies and dietary supplements in NAFLD management, utilizing the ClinicalTrials.gov database.MethodsThis 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.ResultsAn 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.ConclusionThis 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.https://www.frontiersin.org/articles/10.3389/fmed.2023.1227046/fullNAFLDnutraceuticalsdietary supplementsOmega-3 fatty acidsvitamins |
| spellingShingle | Omar E. Hegazi Omar E. Hegazi Samer O. Alalalmeh Samer O. Alalalmeh Ghala Rashid Humaid Alnuaimi Ghala Rashid Humaid Alnuaimi Moyad Shahwan Moyad Shahwan Ammar Abdulrahman Jairoun Ammar Abdulrahman Jairoun Nasser M. Alorfi Shaker A. Majrashi Mustfa Faisal Alkhanani Abdullah Alkhattabi Mansour M. Alourfi Mansour M. Alourfi Faris A. Alsolami Saeed Alsharif Hatim Alshahrani NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials Frontiers in Medicine NAFLD nutraceuticals dietary supplements Omega-3 fatty acids vitamins |
| 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 | NAFLD nutraceuticals dietary supplements Omega-3 fatty acids vitamins |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1227046/full |
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