Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years
Background: Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. However, no effective pharmacological treatment for this condition has been found.Purpose: This study evaluated the effect of a nutraceutical containing bioactive components...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2020-08-01
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| Series: | Frontiers in Endocrinology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fendo.2020.00494/full |
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| author | Yvelise Ferro Tiziana Montalcini Elisa Mazza Daniela Foti Elvira Angotti Micaela Gliozzi Saverio Nucera Sara Paone Ezio Bombardelli Ilaria Aversa Vincenzo Musolino Vincenzo Mollace Arturo Pujia |
| author_facet | Yvelise Ferro Tiziana Montalcini Elisa Mazza Daniela Foti Elvira Angotti Micaela Gliozzi Saverio Nucera Sara Paone Ezio Bombardelli Ilaria Aversa Vincenzo Musolino Vincenzo Mollace Arturo Pujia |
| author_sort | Yvelise Ferro |
| collection | DOAJ |
| description | Background: Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. However, no effective pharmacological treatment for this condition has been found.Purpose: This study evaluated the effect of a nutraceutical containing bioactive components from Bergamot citrus and wild cardoon as a treatment for individuals with fatty liver disease. The primary outcome measure was the change in liver fat content.Methods: A total of 102 patients with liver steatosis were enrolled in a double-blind placebo controlled clinical trial. The intervention group received a nutraceutical containing a Bergamot polyphenol fraction and Cynara Cardunculus extract, 300 mg/day for 12 weeks. The control group received a placebo daily. Liver fat content, by transient elastography, serum transaminases, lipids and glucose were measured at the baseline and the end of the study.Results: We found a greater liver fat content reduction in the participants taking the nutraceutical rather than placebo (−48.2 ± 39 vs. −26.9 ± 43 dB/m, p = 0.02); The percentage CAP score reduction was statistically significant in those with android obesity, overweight/obesity as well as in women. However, after adjustment for weight change, the percentage CAP score reduction was statistically significant only in those over 50 years (44 vs. 78% in placebo and nutraceutical, respectively, p = 0.007).Conclusions: This specific nutraceutical containing bioactive components from Bergamot and wild cardoon reduced the liver fat content during 12 weeks in individuals with liver steatosis over 50 years. If confirmed, this nutraceutical could become the cornerstone treatment of patients affected by liver steatosis.Clinical Trial Registration:www.isrctn.com, identifier ISRCTN12833814. |
| first_indexed | 2024-12-11T08:48:18Z |
| format | Article |
| id | doaj.art-8150cc1825e84202a27eba8df5380cd8 |
| institution | Directory Open Access Journal |
| issn | 1664-2392 |
| language | English |
| last_indexed | 2024-12-11T08:48:18Z |
| publishDate | 2020-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Endocrinology |
| spelling | doaj.art-8150cc1825e84202a27eba8df5380cd82022-12-22T01:14:05ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922020-08-011110.3389/fendo.2020.00494525227Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 YearsYvelise Ferro0Tiziana Montalcini1Elisa Mazza2Daniela Foti3Elvira Angotti4Micaela Gliozzi5Saverio Nucera6Sara Paone7Ezio Bombardelli8Ilaria Aversa9Vincenzo Musolino10Vincenzo Mollace11Arturo Pujia12Department of Health Science, University Magna Grecia, Catanzaro, ItalyDepartment of Clinical and Experimental Medicine, University Magna Grecia, Catanzaro, ItalyDepartment of Medical and Surgical Science, University Magna Grecia, Catanzaro, ItalyDepartment of Health Science, University Magna Grecia, Catanzaro, ItalyDepartment of Clinical and Experimental Medicine, University Magna Grecia, Catanzaro, ItalyDepartment of Health Science, University Magna Grecia, Catanzaro, ItalyDepartment of Health Science, University Magna Grecia, Catanzaro, ItalyDepartment of Health Science, University Magna Grecia, Catanzaro, ItalyPlantexresearch Srl, Milan, ItalyDepartment of Clinical and Experimental Medicine, University Magna Grecia, Catanzaro, ItalyDepartment of Health Science, University Magna Grecia, Catanzaro, ItalyDepartment of Health Science, University Magna Grecia, Catanzaro, ItalyDepartment of Medical and Surgical Science, University Magna Grecia, Catanzaro, ItalyBackground: Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. However, no effective pharmacological treatment for this condition has been found.Purpose: This study evaluated the effect of a nutraceutical containing bioactive components from Bergamot citrus and wild cardoon as a treatment for individuals with fatty liver disease. The primary outcome measure was the change in liver fat content.Methods: A total of 102 patients with liver steatosis were enrolled in a double-blind placebo controlled clinical trial. The intervention group received a nutraceutical containing a Bergamot polyphenol fraction and Cynara Cardunculus extract, 300 mg/day for 12 weeks. The control group received a placebo daily. Liver fat content, by transient elastography, serum transaminases, lipids and glucose were measured at the baseline and the end of the study.Results: We found a greater liver fat content reduction in the participants taking the nutraceutical rather than placebo (−48.2 ± 39 vs. −26.9 ± 43 dB/m, p = 0.02); The percentage CAP score reduction was statistically significant in those with android obesity, overweight/obesity as well as in women. However, after adjustment for weight change, the percentage CAP score reduction was statistically significant only in those over 50 years (44 vs. 78% in placebo and nutraceutical, respectively, p = 0.007).Conclusions: This specific nutraceutical containing bioactive components from Bergamot and wild cardoon reduced the liver fat content during 12 weeks in individuals with liver steatosis over 50 years. If confirmed, this nutraceutical could become the cornerstone treatment of patients affected by liver steatosis.Clinical Trial Registration:www.isrctn.com, identifier ISRCTN12833814.https://www.frontiersin.org/article/10.3389/fendo.2020.00494/fullnutraceuticalsliver steatosislipidflavonoidsliver elastography |
| spellingShingle | Yvelise Ferro Tiziana Montalcini Elisa Mazza Daniela Foti Elvira Angotti Micaela Gliozzi Saverio Nucera Sara Paone Ezio Bombardelli Ilaria Aversa Vincenzo Musolino Vincenzo Mollace Arturo Pujia Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years Frontiers in Endocrinology nutraceuticals liver steatosis lipid flavonoids liver elastography |
| title | Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years |
| title_full | Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years |
| title_fullStr | Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years |
| title_full_unstemmed | Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years |
| title_short | Randomized Clinical Trial: Bergamot Citrus and Wild Cardoon Reduce Liver Steatosis and Body Weight in Non-diabetic Individuals Aged Over 50 Years |
| title_sort | randomized clinical trial bergamot citrus and wild cardoon reduce liver steatosis and body weight in non diabetic individuals aged over 50 years |
| topic | nutraceuticals liver steatosis lipid flavonoids liver elastography |
| url | https://www.frontiersin.org/article/10.3389/fendo.2020.00494/full |
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