Cargando…
Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study
The main guidelines for cardiovascular disease prevention suggest that nutraceuticals could be an efficacious tool to improve lipid pattern. Our aim was to carry out a clinical trial comparing the metabolic effects of a combined nutraceutical containing both red yeast rice and polyunsaturated fatty...
Autores principales: | , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mary Ann Liebert, Inc.
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4638196/ https://www.ncbi.nlm.nih.gov/pubmed/26274827 http://dx.doi.org/10.1089/jmf.2015.0024 |
_version_ | 1782399887405481984 |
---|---|
author | Cicero, Arrigo F.G. Derosa, Giuseppe Pisciotta, Livia Barbagallo, Carlo |
author_facet | Cicero, Arrigo F.G. Derosa, Giuseppe Pisciotta, Livia Barbagallo, Carlo |
author_sort | Cicero, Arrigo F.G. |
collection | PubMed |
description | The main guidelines for cardiovascular disease prevention suggest that nutraceuticals could be an efficacious tool to improve lipid pattern. Our aim was to carry out a clinical trial comparing the metabolic effects of a combined nutraceutical containing both red yeast rice and polyunsaturated fatty acids (PUFAs) and a phytosterol-based approach in a setting of clinical practice. This was a multicenter open study with parallel control. We consecutively enrolled 107 pharmacologically untreated subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome, assigned to 8-week treatment with a combined treatment with red yeast rice (Dif1Stat(®), including 5 mg monacolin K) and 610 mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600 mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; −42.50 ± 18.1 mg/dL), low-density lipoprotein cholesterol (LDL-C; −37.6 ± 13.6 mg/dL), triglycerides (TG; −19.8 ± 25.1 mg/dL), and non-HDL-C (−43.1 ± 17.7 mg/dL) (all P < .001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (−13.7 ± 4.3 mg/dL), LDL-C (−17.6 ± 8.5 mg/dL), and non-HDL-C (−14.1 ± 5.6 mg/dL) (all P < .001). When comparing the combined nutraceutical effect with that of phytosterols, we observed that the combined nutraceutical intake was associated with a significantly higher decrease in TC, LDL-C, TG, and non-HDL-C (all P < .001). In the short term, a combined nutraceutical containing red yeast rice and PUFAs is well tolerated and efficacious in reducing plasma lipid levels in subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome. |
format | Online Article Text |
id | pubmed-4638196 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Mary Ann Liebert, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-46381962015-11-20 Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study Cicero, Arrigo F.G. Derosa, Giuseppe Pisciotta, Livia Barbagallo, Carlo J Med Food Full Communications The main guidelines for cardiovascular disease prevention suggest that nutraceuticals could be an efficacious tool to improve lipid pattern. Our aim was to carry out a clinical trial comparing the metabolic effects of a combined nutraceutical containing both red yeast rice and polyunsaturated fatty acids (PUFAs) and a phytosterol-based approach in a setting of clinical practice. This was a multicenter open study with parallel control. We consecutively enrolled 107 pharmacologically untreated subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome, assigned to 8-week treatment with a combined treatment with red yeast rice (Dif1Stat(®), including 5 mg monacolin K) and 610 mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600 mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; −42.50 ± 18.1 mg/dL), low-density lipoprotein cholesterol (LDL-C; −37.6 ± 13.6 mg/dL), triglycerides (TG; −19.8 ± 25.1 mg/dL), and non-HDL-C (−43.1 ± 17.7 mg/dL) (all P < .001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (−13.7 ± 4.3 mg/dL), LDL-C (−17.6 ± 8.5 mg/dL), and non-HDL-C (−14.1 ± 5.6 mg/dL) (all P < .001). When comparing the combined nutraceutical effect with that of phytosterols, we observed that the combined nutraceutical intake was associated with a significantly higher decrease in TC, LDL-C, TG, and non-HDL-C (all P < .001). In the short term, a combined nutraceutical containing red yeast rice and PUFAs is well tolerated and efficacious in reducing plasma lipid levels in subjects affected by primary polygenic hypercholesterolemia and metabolic syndrome. Mary Ann Liebert, Inc. 2015-11-01 /pmc/articles/PMC4638196/ /pubmed/26274827 http://dx.doi.org/10.1089/jmf.2015.0024 Text en © Arrigo F.G. Cicero et al. 2015; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons Attribution Noncommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. |
spellingShingle | Full Communications Cicero, Arrigo F.G. Derosa, Giuseppe Pisciotta, Livia Barbagallo, Carlo Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study |
title | Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study |
title_full | Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study |
title_fullStr | Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study |
title_full_unstemmed | Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study |
title_short | Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study |
title_sort | testing the short-term efficacy of a lipid-lowering nutraceutical in the setting of clinical practice: a multicenter study |
topic | Full Communications |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4638196/ https://www.ncbi.nlm.nih.gov/pubmed/26274827 http://dx.doi.org/10.1089/jmf.2015.0024 |
work_keys_str_mv | AT ciceroarrigofg testingtheshorttermefficacyofalipidloweringnutraceuticalinthesettingofclinicalpracticeamulticenterstudy AT derosagiuseppe testingtheshorttermefficacyofalipidloweringnutraceuticalinthesettingofclinicalpracticeamulticenterstudy AT pisciottalivia testingtheshorttermefficacyofalipidloweringnutraceuticalinthesettingofclinicalpracticeamulticenterstudy AT barbagallocarlo testingtheshorttermefficacyofalipidloweringnutraceuticalinthesettingofclinicalpracticeamulticenterstudy |