Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study

Carlo Maria Barbagallo, Livia Pisciotta, Arrigo F.G. Cicero, Giuseppe Derosa

Risultato della ricerca: Article

9 Citazioni (Scopus)

Abstract

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 5mg monacolin K) and 610mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; -42.50±18.1mg/dL), low-density lipoprotein cholesterol (LDL-C; -37.6±13.6mg/dL), triglycerides (TG; -19.8±25.1mg/dL), and non-HDL-C (-43.1±17.7mg/dL) (all P<.001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (-13.7±4.3mg/dL), LDL-C (-17.6±8.5mg/dL), and non-HDL-C (-14.1±5.6mg/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.
Lingua originaleEnglish
pagine (da-a)1270-1273
Numero di pagine4
RivistaJournal of Medicinal Food
Volume18
Stato di pubblicazionePublished - 2015

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Dietary Supplements
Multicenter Studies
Phytosterols
Lipids
Unsaturated Fatty Acids
Hypercholesterolemia
Lovastatin
LDL Cholesterol
Triglycerides
Cardiovascular Diseases
Cholesterol
Clinical Trials
Guidelines
Therapeutics
red yeast rice

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study. / Barbagallo, Carlo Maria; Pisciotta, Livia; Cicero, Arrigo F.G.; Derosa, Giuseppe.

In: Journal of Medicinal Food, Vol. 18, 2015, pag. 1270-1273.

Risultato della ricerca: Article

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abstract = "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{\^A}{\circledR}, including 5mg monacolin K) and 610mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; -42.50{\^A}±18.1mg/dL), low-density lipoprotein cholesterol (LDL-C; -37.6{\^A}±13.6mg/dL), triglycerides (TG; -19.8{\^A}±25.1mg/dL), and non-HDL-C (-43.1{\^A}±17.7mg/dL) (all P<.001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (-13.7{\^A}±4.3mg/dL), LDL-C (-17.6{\^A}±8.5mg/dL), and non-HDL-C (-14.1{\^A}±5.6mg/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.",
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T1 - Testing the Short-Term Efficacy of a Lipid-Lowering Nutraceutical in the Setting of Clinical Practice: A Multicenter Study

AU - Barbagallo, Carlo Maria

AU - Pisciotta, Livia

AU - Cicero, Arrigo F.G.

AU - Derosa, Giuseppe

PY - 2015

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N2 - 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 5mg monacolin K) and 610mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; -42.50±18.1mg/dL), low-density lipoprotein cholesterol (LDL-C; -37.6±13.6mg/dL), triglycerides (TG; -19.8±25.1mg/dL), and non-HDL-C (-43.1±17.7mg/dL) (all P<.001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (-13.7±4.3mg/dL), LDL-C (-17.6±8.5mg/dL), and non-HDL-C (-14.1±5.6mg/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.

AB - 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 5mg monacolin K) and 610mg PUFAs. A parallel group of 30 subjects with similar characteristics was treated with phytosterols 1600mg/die. In the combined nutraceutical group, compared with the baseline level, we observed a significant decrease in total cholesterol (TC; -42.50±18.1mg/dL), low-density lipoprotein cholesterol (LDL-C; -37.6±13.6mg/dL), triglycerides (TG; -19.8±25.1mg/dL), and non-HDL-C (-43.1±17.7mg/dL) (all P<.001). In the phytosterol-treated group, compared to the baseline level, we observed a significant decrease in TC (-13.7±4.3mg/dL), LDL-C (-17.6±8.5mg/dL), and non-HDL-C (-14.1±5.6mg/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.

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JO - Journal of Medicinal Food

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SN - 1096-620X

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