PMID- 28579756
OWN - NLM
STAT- MEDLINE
DCOM- 20180417
LR  - 20220331
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 11
DP  - 2017
TI  - Effect of a food supplement containing berberine, monacolin K, hydroxytyrosol and 
      coenzyme Q(10) on lipid levels: a randomized, double-blind, placebo controlled 
      study.
PG  - 1585-1592
LID - 10.2147/DDDT.S128623 [doi]
AB  - PURPOSE: To evaluate the ability of the new food supplement, Body Lipid (BL), 
      containing red yeast rice, berberine, coenzyme Q(10) and hydroxytyrosol, to lower 
      the LDL-C in patients with mild-to-moderate hypercholesterolemia and to assess 
      the overall safety profile of the product. METHODS: In this multicenter, 
      randomized, double-blind, placebo and active comparator (the marketed Armolipid 
      Plus((R)) [AM]) controlled study, 158 hypercholesterolemic patients were randomized 
      following a 4-week dietary run-in period. After 4 weeks of treatment with a daily 
      oral dose of the new food supplement BL, AM or placebo, plus diet, the main 
      outcome was the decrease of LDL-C, total cholesterol (TC), and triglyceride 
      levels. FINDINGS: The absolute changes of LDL-C and TC levels from baseline, at 
      week 4 were: -39.1 mg/dL +/-17.76 and -45.9 mg/dL +/-21.54, respectively in the BL 
      group; 5.7 mg/dL +/-14.98 and 2.4 mg/dL +/-18.43, respectively in the placebo group. 
      Results were statistically significant. In terms of mean percentage, BL was shown 
      to be more effective in lowering LDL-C levels as compared to placebo and the 
      active comparator (AM), with a reduction of -26.3%, +4.2%, -18.3%, respectively. 
      Five adverse events (AEs) were reported by five patients after the initiation of 
      the study treatment: two in the BL group (influence and insomnia), two in the AM 
      group (ear pain and rash), and one in the placebo group (back pain). All AEs were 
      mild in intensity, except for back pain (severe). The case of insomnia in the BL 
      group and the case of rash in the AM group were judged as treatment related. The 
      safety review of the laboratory (blood and urine) analyses, vital signs and 
      physical findings did not show any clinical effect of the study products on any 
      of the parameters. IMPLICATIONS: BL showed a good efficacy and safety profile 
      and, for this reason, it can be considered an alternative to pharmacological 
      treatment, for patients with mild-to-moderate hypercholesterolemia.
FAU - D'Addato, Sergio
AU  - D'Addato S
AD  - Medical and Surgical Science Department, S. Orsola Malpighi Hospital, University 
      of Bologna, Bologna, Italy.
FAU - Scandiani, Luciana
AU  - Scandiani L
AD  - Department of Internal Medicine, Azienda Ospedaliera-Polo Universitario Ospedale 
      Luigi Sacco, Milan, Italy.
FAU - Mombelli, Giuliana
AU  - Mombelli G
AD  - Dyslipidemia Center, Hospital Niguarda Ca' Granda, Milan, Italy.
FAU - Focanti, Francesca
AU  - Focanti F
AD  - ACRAF S.p.A. Angelini Research Center RR&D, Ancona, Italy.
FAU - Pelacchi, Federica
AU  - Pelacchi F
AD  - ACRAF S.p.A. Angelini Research Center RR&D, Ancona, Italy.
FAU - Salvatori, Enrica
AU  - Salvatori E
AD  - ACRAF S.p.A. Angelini Research Center RR&D, Ancona, Italy.
FAU - Di Loreto, Giorgio
AU  - Di Loreto G
AD  - ACRAF S.p.A. Angelini Research Center RR&D, Ancona, Italy.
FAU - Comandini, Alessandro
AU  - Comandini A
AD  - ACRAF S.p.A. Angelini Research Center RR&D, Ancona, Italy.
FAU - Maffioli, Pamela
AU  - Maffioli P
AD  - Center of Diabetes and Metabolic Diseases, Department of Internal Medicine and 
      Therapeutics, Fondazione IRCCS Policlinico San Matteo, University of Pavia, 
      Pavia, Italy.
FAU - Derosa, Giuseppe
AU  - Derosa G
AD  - Center of Diabetes and Metabolic Diseases, Department of Internal Medicine and 
      Therapeutics, Fondazione IRCCS Policlinico San Matteo, University of Pavia, 
      Pavia, Italy.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170523
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Biomarkers)
RN  - 0 (Cholesterol, LDL)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anticholesteremic Agents/adverse effects/*therapeutic use
MH  - Biomarkers/blood
MH  - Cholesterol, LDL/*blood
MH  - *Dietary Supplements/adverse effects
MH  - Double-Blind Method
MH  - Down-Regulation
MH  - Female
MH  - Humans
MH  - Hypercholesterolemia/blood/diagnosis/*drug therapy
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC5447697
OTO - NOTNLM
OT  - berberine
OT  - coenzyme Q10
OT  - hydroxytyrosol
OT  - lipid profile
OT  - red yeast rice
COIS- Disclosure F Focanti, F Pelacchi, E Salvatori, G Di Loreto, and A Comandini are 
      employed by ACRAF S.p.A. Angelini Research Center RR&D. The authors report no 
      other conflicts of interest in this work.
EDAT- 2017/06/06 06:00
MHDA- 2018/04/18 06:00
PMCR- 2017/05/23
CRDT- 2017/06/06 06:00
PHST- 2017/06/06 06:00 [entrez]
PHST- 2017/06/06 06:00 [pubmed]
PHST- 2018/04/18 06:00 [medline]
PHST- 2017/05/23 00:00 [pmc-release]
AID - dddt-11-1585 [pii]
AID - 10.2147/DDDT.S128623 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2017 May 23;11:1585-1592. doi: 10.2147/DDDT.S128623. 
      eCollection 2017.