NAFLD and nutraceuticals: a review of completed phase III and IV clinical trials
Front Med (Lausanne) . 2023 Aug 1;10:1227046. doi: 10.3389/fmed.2023.1227046
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
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.
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27+ VitaminDWiki pages with NON-ALCOHOLIC or NAFLD in title
This list is automatcially updated
Items found: 28
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NAFLD and Vitamin D - many studies |
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25 Sep, 2023 |
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NAFLD and Vitamin D - many studies |
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25 Sep, 2023 |
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NAFLD treated by Vitamin D, Omega-3, etc. Aug 2023 |
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21 Aug, 2023 |
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NAFLD in children nicely treated by combination of Vitamin D and Omega-3 – RCT Dec 2016 |
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21 Aug, 2023 |
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NAFLD weakly associated with low vitamin D – meta-analysis 2013 |
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21 Aug, 2023 |
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Vitamin D is one of only 2 ways to easily prevent NAFLD (380,000 people) – Oct 2021 |
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16 Apr, 2023 |
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Non-alcoholic fatty liver disease: 75 percent of overweight adults and type II diabetics – Aug 2022 |
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16 Jul, 2022 |
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NAFLD not reduced by 1680 IU of vitamin D plus Omega-3 (no surprise) – RCT Jan 2022 |
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24 Jan, 2022 |
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NAFLD was no longer associated with low vitamin D after “adjusting’ for obesity – May 2021 |
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02 Nov, 2021 |
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Liver Inflammation (NAFLD) is prevented by Vitamin D – review May 2015 |
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05 Oct, 2021 |
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Non-Alcoholic Fatty Liver Disease (NAFLD) treated by Vitamin D (20,000 IU weekly after loading dose) – RCT June 2016 |
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05 Oct, 2021 |
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NAFLD somewhat treated in children with 2,000 IU Vitamin D daily – RCT Aug 2021 |
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30 Aug, 2021 |
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Strong association of non alcoholic fatty liver disease and low vitamin D |
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28 Oct, 2020 |
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Non-alcoholic Fatty Liver Disease (NAFLD) treated by Vitamin D (in rats this time) – Dec 2019 |
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04 Dec, 2019 |
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Non-alcoholic fatty liver disease and the Vitamin D Receptor – editorial Sept 2019 |
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29 Sep, 2019 |
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NAFLD associated with low vitamin D (in children too) – meta-analysis Aug 2019 |
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06 Aug, 2019 |
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Severe Non-Alcoholic fatty liver disease treated by Omega-3 – RCT April 2018 |
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02 Mar, 2019 |
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Non-alcoholic Fatty Liver Disease (4 in 10 seniors) and Vitamin D |
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26 Aug, 2018 |
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NAFLD is treated by Vitamin D, Omega-3, Curcumin, Silymarinm, etc. Aug 2018 |
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26 Aug, 2018 |
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Non-Alcoholic Fatty Liver Disease treated by Omega-3 – three meta-analysis 2016-2017 |
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13 Aug, 2017 |
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Non-Alcoholic Fatty Liver Disease treated by Omega-3 – meta-analysis Oct 2016 |
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13 Aug, 2017 |
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Non-alcoholic fatty liver disease associated with much lower vitamin D – Aug 2014 |
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24 Jul, 2016 |
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Non-alcoholic fatty liver disease (NAFLD) reduced somewhat by 50,000 IU vitamin D every 2 weeks – RCT Sept 2014 |
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13 Jul, 2016 |
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Sarcopenia and non-alcoholic fatty liver disease (vitamin D not mentioned) – Sept 2013 |
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07 Mar, 2015 |
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Hepatitis C, non-alcoholic fatty liver disease and vitamin D deficiency – Dec 2014 |
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31 Dec, 2014 |
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Non-alcoholic fatty liver disease associated with low vitamin D – independent of BMI – June 2014 |
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31 Dec, 2014 |
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Fatty liver disease (NAFLD), metabolic syndrome, and perhaps vitamin D – June 2013 |
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24 Mar, 2014 |
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Fatty liver disease (NAFLD) and the importance of vitamin D – Oct 2012 |
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25 Jul, 2013 |