TY - JOUR
T1 - Effects on oral fat load of a nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols
T2 - A randomized, placebo controlled trial
AU - Derosa, Giuseppe
AU - Catena, Gabriele
AU - Raddino, Riccardo
AU - Gaudio, Giovanni
AU - Maggi, Antonio
AU - D'Angelo, Angela
AU - Maffioli, Pamela
N1 - Copyright © 2018 Elsevier GmbH. All rights reserved.
PY - 2018/3/15
Y1 - 2018/3/15
N2 - BACKGROUND: In literature, there are several studies about the effects of nutraceutical combinations at fasting, but data in post-prandial phase are lacking.PURPOSE: We planned a study to evaluate the efficacy and safety of a nutraceutical agent containing fermented red rice, phytosterols and olive polyphenols compared to placebo in a sample of Caucasian patients with low cardiovascular risk, both at fasting and after an oral fat load.STUDY DESIGN: Eighty patients were randomized to receive, as addition to diet and physical activity, a nutraceutical combination containing fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols or placebo (control group), once a day.METHODS: We evaluated at baseline, and after 3 months: body mass index, fasting plasma glucose, lipid profile, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, and soluble endothelial-leukocyte adhesion molecule-1. We evaluated these parameters both at fasting, and after an oral fat load.RESULTS: Nutraceutical combination gave a reduction of total cholesterol, triglycerides, and low-density lipoprotein cholesterol, both compared to baseline (p < 0.05 for all), and to placebo (p < 0.05 for all). We recorded a reduction of soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, and sE-selectin in the group treated with nutraceutical combination, both compared to baseline (p < 0.05 for all), and to placebo (p < 0.05 for all). Parameters recorded during oral fat load improved compared to the oral fat load performed at baseline with the nutraceutical combination.CONCLUSIONS: The nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols seems to be effective in improving lipid profile and markers of endothelial damage in dyslipidemic patients in primary prevention at low risk for developing cardiovascular disease. The true novelty of this study, however, is the improvement of endothelial damage after an oral fat load compared to placebo.
AB - BACKGROUND: In literature, there are several studies about the effects of nutraceutical combinations at fasting, but data in post-prandial phase are lacking.PURPOSE: We planned a study to evaluate the efficacy and safety of a nutraceutical agent containing fermented red rice, phytosterols and olive polyphenols compared to placebo in a sample of Caucasian patients with low cardiovascular risk, both at fasting and after an oral fat load.STUDY DESIGN: Eighty patients were randomized to receive, as addition to diet and physical activity, a nutraceutical combination containing fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols or placebo (control group), once a day.METHODS: We evaluated at baseline, and after 3 months: body mass index, fasting plasma glucose, lipid profile, soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, and soluble endothelial-leukocyte adhesion molecule-1. We evaluated these parameters both at fasting, and after an oral fat load.RESULTS: Nutraceutical combination gave a reduction of total cholesterol, triglycerides, and low-density lipoprotein cholesterol, both compared to baseline (p < 0.05 for all), and to placebo (p < 0.05 for all). We recorded a reduction of soluble intercellular adhesion molecule-1, soluble vascular cell adhesion molecule-1, and sE-selectin in the group treated with nutraceutical combination, both compared to baseline (p < 0.05 for all), and to placebo (p < 0.05 for all). Parameters recorded during oral fat load improved compared to the oral fat load performed at baseline with the nutraceutical combination.CONCLUSIONS: The nutraceutical combination of fermented red rice, sterol esters and stanols, curcumin, and olive polyphenols seems to be effective in improving lipid profile and markers of endothelial damage in dyslipidemic patients in primary prevention at low risk for developing cardiovascular disease. The true novelty of this study, however, is the improvement of endothelial damage after an oral fat load compared to placebo.
KW - Biomarkers/blood
KW - Body Mass Index
KW - Cholesterol, LDL/blood
KW - Curcumin/pharmacology
KW - Dietary Supplements
KW - Dyslipidemias/prevention & control
KW - E-Selectin/blood
KW - Female
KW - Humans
KW - Intercellular Adhesion Molecule-1/blood
KW - Lipids/blood
KW - Male
KW - Middle Aged
KW - Olea/chemistry
KW - Oryza
KW - Phytosterols/pharmacology
KW - Polyphenols/pharmacology
KW - Triglycerides/blood
U2 - 10.1016/j.phymed.2018.01.014
DO - 10.1016/j.phymed.2018.01.014
M3 - Article
C2 - 29655700
VL - 42
SP - 75
EP - 82
JO - Phytomedicine
JF - Phytomedicine
SN - 0944-7113
ER -