A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease
Abstract Background Currently, there is no approved medication for non-alcoholic fatty liver disease management. Pre-clinical and clinical studies showed that several bioactive molecules in plants or foods (i.e., curcumin complex, bergamot polyphenol fraction, artichoke leaf extract, black seed oil,...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-08-01
|
| Series: | Journal of Translational Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12967-022-03579-1 |
| _version_ | 1828322650004389888 |
|---|---|
| author | Yvelise Ferro Roberta Pujia Elisa Mazza Lidia Lascala Oscar Lodari Samantha Maurotti Arturo Pujia Tiziana Montalcini |
| author_facet | Yvelise Ferro Roberta Pujia Elisa Mazza Lidia Lascala Oscar Lodari Samantha Maurotti Arturo Pujia Tiziana Montalcini |
| author_sort | Yvelise Ferro |
| collection | DOAJ |
| description | Abstract Background Currently, there is no approved medication for non-alcoholic fatty liver disease management. Pre-clinical and clinical studies showed that several bioactive molecules in plants or foods (i.e., curcumin complex, bergamot polyphenol fraction, artichoke leaf extract, black seed oil, concentrate fish oil, picroliv root, glutathione, S-adenosyl-l-methionine and other natural ingredients) have been associated with improved fatty liver disease. Starting from these evidences, our purpose was to evaluate the effects of a novel combination of abovementioned nutraceuticals as a treatment for adults with fatty liver disease. Methods A total of 140 participants with liver steatosis were enrolled in a randomized, double-blind, placebo controlled clinical trial. The intervention group received six softgel capsules daily of a nutraceutical (namely Livogen Plus®) containing a combination of natural bioactive components for 12 weeks. The control group received six softgel capsules daily of a placebo containing maltodextrin for 12 weeks. The primary outcome measure was the change in liver fat content (CAP score). CAP score, by transient elastography, serum glucose, lipids, transaminases, and cytokines were measured at baseline and after intervention. Results After adjustment for confounding variables (i.e., CAP score and triglyceride at baseline, and changes of serum γGT, and vegetable and animal proteins, cholesterol intake at the follow-up), we found a greater CAP score reduction in the nutraceutical group rather than placebo (− 34 ± 5 dB/m vs. − 20 ± 5 dB/m, respectively; p = 0.045). The CAP score reduction (%) was even greater in those with aged 60 or less, low baseline HDL-C, AST reduction as well as in men. Conclusion Our results showed that a new combination of bioactive molecules as nutraceutical was safe and effective in reducing liver fat content over 12 weeks in individuals with hepatic steatosis. Trial registration ISRCTN, ISRCTN70887063. Registered 03 August 2021—retrospectively registered, https://doi.org/10.1186/ISRCTN70887063 |
| first_indexed | 2024-04-13T18:43:31Z |
| format | Article |
| id | doaj.art-59d961a9975e4d9e9d632870a6143bc3 |
| institution | Directory Open Access Journal |
| issn | 1479-5876 |
| language | English |
| last_indexed | 2024-04-13T18:43:31Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Translational Medicine |
| spelling | doaj.art-59d961a9975e4d9e9d632870a6143bc32022-12-22T02:34:39ZengBMCJournal of Translational Medicine1479-58762022-08-0120111710.1186/s12967-022-03579-1A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver diseaseYvelise Ferro0Roberta Pujia1Elisa Mazza2Lidia Lascala3Oscar Lodari4Samantha Maurotti5Arturo Pujia6Tiziana Montalcini7Department of Medical and Surgical Science, University Magna GræciaDepartment of Medical and Surgical Science, University Magna GræciaDepartment of Medical and Surgical Science, University Magna GræciaDepartment of Clinical and Experimental Medicine, University Magna GreæciaDepartment of Clinical and Experimental Medicine, University Magna GreæciaDepartment of Clinical and Experimental Medicine, University Magna GreæciaDepartment of Medical and Surgical Science, University Magna GræciaDepartment of Clinical and Experimental Medicine, University Magna GreæciaAbstract Background Currently, there is no approved medication for non-alcoholic fatty liver disease management. Pre-clinical and clinical studies showed that several bioactive molecules in plants or foods (i.e., curcumin complex, bergamot polyphenol fraction, artichoke leaf extract, black seed oil, concentrate fish oil, picroliv root, glutathione, S-adenosyl-l-methionine and other natural ingredients) have been associated with improved fatty liver disease. Starting from these evidences, our purpose was to evaluate the effects of a novel combination of abovementioned nutraceuticals as a treatment for adults with fatty liver disease. Methods A total of 140 participants with liver steatosis were enrolled in a randomized, double-blind, placebo controlled clinical trial. The intervention group received six softgel capsules daily of a nutraceutical (namely Livogen Plus®) containing a combination of natural bioactive components for 12 weeks. The control group received six softgel capsules daily of a placebo containing maltodextrin for 12 weeks. The primary outcome measure was the change in liver fat content (CAP score). CAP score, by transient elastography, serum glucose, lipids, transaminases, and cytokines were measured at baseline and after intervention. Results After adjustment for confounding variables (i.e., CAP score and triglyceride at baseline, and changes of serum γGT, and vegetable and animal proteins, cholesterol intake at the follow-up), we found a greater CAP score reduction in the nutraceutical group rather than placebo (− 34 ± 5 dB/m vs. − 20 ± 5 dB/m, respectively; p = 0.045). The CAP score reduction (%) was even greater in those with aged 60 or less, low baseline HDL-C, AST reduction as well as in men. Conclusion Our results showed that a new combination of bioactive molecules as nutraceutical was safe and effective in reducing liver fat content over 12 weeks in individuals with hepatic steatosis. Trial registration ISRCTN, ISRCTN70887063. Registered 03 August 2021—retrospectively registered, https://doi.org/10.1186/ISRCTN70887063https://doi.org/10.1186/s12967-022-03579-1NutraceuticalFatty liver diseaseBioactive componentsHepatic steatosis |
| spellingShingle | Yvelise Ferro Roberta Pujia Elisa Mazza Lidia Lascala Oscar Lodari Samantha Maurotti Arturo Pujia Tiziana Montalcini A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease Journal of Translational Medicine Nutraceutical Fatty liver disease Bioactive components Hepatic steatosis |
| title | A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease |
| title_full | A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease |
| title_fullStr | A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease |
| title_full_unstemmed | A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease |
| title_short | A new nutraceutical (Livogen Plus®) improves liver steatosis in adults with non-alcoholic fatty liver disease |
| title_sort | new nutraceutical livogen plus r improves liver steatosis in adults with non alcoholic fatty liver disease |
| topic | Nutraceutical Fatty liver disease Bioactive components Hepatic steatosis |
| url | https://doi.org/10.1186/s12967-022-03579-1 |
| work_keys_str_mv | AT yveliseferro anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT robertapujia anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT elisamazza anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT lidialascala anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT oscarlodari anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT samanthamaurotti anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT arturopujia anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT tizianamontalcini anewnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT yveliseferro newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT robertapujia newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT elisamazza newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT lidialascala newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT oscarlodari newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT samanthamaurotti newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT arturopujia newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease AT tizianamontalcini newnutraceuticallivogenplusimprovesliversteatosisinadultswithnonalcoholicfattyliverdisease |