Randomized, Double-Blind, Placebo-Controlled Trial to Test the Effects of a Nutraceutical Combination Monacolin K-Free on the Lipid and Inflammatory Profile of Subjects with Hypercholesterolemia.


Journal

Nutrients
ISSN: 2072-6643
Titre abrégé: Nutrients
Pays: Switzerland
ID NLM: 101521595

Informations de publication

Date de publication:
08 Jul 2022
Historique:
received: 09 06 2022
revised: 30 06 2022
accepted: 06 07 2022
entrez: 27 7 2022
pubmed: 28 7 2022
medline: 29 7 2022
Statut: epublish

Résumé

Nutraceutical combinations (NCs) against hypercholesterolemia are increasing in the marketplace. However, the availability of NCs without monacolin K is scarce even though the statin-intolerant population needs it. This study is a parallel-group, randomized, placebo-controlled, double-blind trial. We evaluated the effects of the NC containing phytosterols, bergamot, olive fruits, and vitamin K Compared to the placebo, at 6 and 12 weeks, NC did not significantly reduce total cholesterol ( The evaluated nutraceutical combination did not change serum lipid profile and inflammatory parameters, at least not with the daily dose applied in the present study.

Sections du résumé

BACKGROUND BACKGROUND
Nutraceutical combinations (NCs) against hypercholesterolemia are increasing in the marketplace. However, the availability of NCs without monacolin K is scarce even though the statin-intolerant population needs it.
METHODS METHODS
This study is a parallel-group, randomized, placebo-controlled, double-blind trial. We evaluated the effects of the NC containing phytosterols, bergamot, olive fruits, and vitamin K
RESULTS RESULTS
Compared to the placebo, at 6 and 12 weeks, NC did not significantly reduce total cholesterol (
CONCLUSIONS CONCLUSIONS
The evaluated nutraceutical combination did not change serum lipid profile and inflammatory parameters, at least not with the daily dose applied in the present study.

Identifiants

pubmed: 35889769
pii: nu14142812
doi: 10.3390/nu14142812
pmc: PMC9324786
pii:
doi:

Substances chimiques

Biomarkers 0
Cholesterol, LDL 0
Lipids 0
MicroRNAs 0
Triglycerides 0
C-Reactive Protein 9007-41-4
Lovastatin 9LHU78OQFD

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Regione Marche, Italy
ID : project PrInT AGE 10439

Références

Mol Nutr Food Res. 2012 Jul;56(7):1058-72
pubmed: 22623436
Nutr Metab Cardiovasc Dis. 2017 Jan;27(1):2-17
pubmed: 27956024
Eur Heart J. 2016 Aug 1;37(29):2315-2381
pubmed: 27222591
Endocr Pract. 2017 Apr;23(Suppl 2):1-87
pubmed: 28437620
Front Immunol. 2018 Jun 22;9:1462
pubmed: 29988385
Integr Food Nutr Metab. 2019 Mar;6(2):
pubmed: 31057945
Trials. 2020 Jul 6;21(1):616
pubmed: 32631422
Arq Bras Cardiol. 2017 Nov;109(5):475-482
pubmed: 29267628
JAMA. 2001 May 16;285(19):2486-97
pubmed: 11368702
JAMA Intern Med. 2017 Jan 1;177(1):21-23
pubmed: 27838697
Atherosclerosis. 2017 Sep;264:83-91
pubmed: 28716457
Molecules. 2022 Jan 14;27(2):
pubmed: 35056839
Curr Nutr Rep. 2016 Jun;5(2):90-98
pubmed: 27648390
Nutr Rev. 2011 Jul;69(7):371-82
pubmed: 21729090
Circ Res. 2017 Sep 1;121(6):677-694
pubmed: 28860318
EFSA J. 2018 Aug 03;16(8):e05368
pubmed: 32626016
Int J Mol Sci. 2019 Aug 25;20(17):
pubmed: 31450694
Nat Prod Rep. 2019 Jun 19;36(6):869-888
pubmed: 31187844
Clin Nutr. 2015 Dec;34(6):1146-54
pubmed: 25491246
Eur Heart J. 2016 Oct 14;37(39):2999-3058
pubmed: 27567407
Front Genet. 2013 Jun 26;4:121
pubmed: 23805154
Molecules. 2019 May 24;24(10):
pubmed: 31137753
Int J Behav Nutr Phys Act. 2011 Oct 21;8:115
pubmed: 22018588
Ageing Res Rev. 2020 Aug;61:101074
pubmed: 32335301
Int J Gen Med. 2019 Apr 30;12:167-171
pubmed: 31118742
Eur J Nutr. 2017 Jun;56(4):1421-1432
pubmed: 26951205
J Atheroscler Thromb. 2019 Mar 1;26(3):207-215
pubmed: 30662020
Nutrients. 2021 Jan 19;13(1):
pubmed: 33477894
Front Pharmacol. 2016 Jan 06;6:299
pubmed: 26779019
Crit Rev Food Sci Nutr. 2020;60(18):3133-3143
pubmed: 31670973
N Engl J Med. 2019 Oct 17;381(16):1557-1567
pubmed: 31618541
Clin Chim Acta. 2019 Oct;497:104-109
pubmed: 31326419
Evid Based Complement Alternat Med. 2015;2015:957031
pubmed: 26221182
Nutrients. 2021 Sep 08;13(9):
pubmed: 34579005
Diabetes Res Clin Pract. 2021 Jan;171:108585
pubmed: 33310128
Foods. 2022 Mar 15;11(6):
pubmed: 35327262
Circ Res. 2018 Oct 26;123(10):1118-1120
pubmed: 30359201
Br J Nutr. 2013 Oct;110(8):1357-68
pubmed: 23590754
Glob Heart. 2020 Feb 06;15(1):3
pubmed: 32489776
Stroke. 2012 Jul;43(7):1768-74
pubmed: 22496337
Ageing Res Rev. 2021 Sep;70:101374
pubmed: 34082077
Br J Pharmacol. 2017 Jun;174(11):1450-1463
pubmed: 27685833
J Agric Food Chem. 2007 Sep 5;55(18):7609-14
pubmed: 17683140
Int Immunopharmacol. 2022 Jul;108:108876
pubmed: 35623295
Exp Ther Med. 2017 Aug;14(2):947-952
pubmed: 28781617

Auteurs

Olga Protic (O)

Cardiology Unit, Italian National Research Center on Aging, IRCCS INRCA, 60127 Ancona, Italy.

Raffaele Di Pillo (R)

Cardiology Unit, Italian National Research Center on Aging, IRCCS INRCA, 60127 Ancona, Italy.

Alberto Montesanto (A)

Department of Biology, Ecology and Earth Sciences, University of Calabria, 87036 Rende, Italy.

Roberta Galeazzi (R)

Clinical Laboratory and Molecular Diagnostic, Italian National Research Center on Aging, IRCCS INRCA, 60127 Ancona, Italy.

Giulia Matacchione (G)

Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, 60126 Ancona, Italy.

Angelica Giuliani (A)

Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, 60126 Ancona, Italy.

Jacopo Sabbatinelli (J)

Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, 60126 Ancona, Italy.

Felicia Gurău (F)

Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, 60126 Ancona, Italy.

Andrea Silvestrini (A)

Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, 60126 Ancona, Italy.

Fabiola Olivieri (F)

Department of Clinical and Molecular Sciences, DISCLIMO, Università Politecnica delle Marche, 60126 Ancona, Italy.
Center of Clinical Pathology and Innovative Therapy, Italian National Research Center on Aging, IRCCS INRCA, 60127 Ancona, Italy.

Roberto Antonicelli (R)

Cardiology Unit, Italian National Research Center on Aging, IRCCS INRCA, 60127 Ancona, Italy.

Anna Rita Bonfigli (AR)

Scientific Direction, Italian National Research Center on Aging, IRCCS INRCA, 60127 Ancona, Italy.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH