Clinical trial NCT01562080: Combined Effects of Bioactive Compounds in Lipid Profile
Official title: Combined Effects of Bioactive Compounds (ARMOLIPID PLUS ®) on Lipid Profile and Clinical Criteria of Metabolic Syndrome in Patients With Serum Elevated LDL-C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Low-density-lipoprotein-type
Elevated Triglycerides
Keywords: hyperlipidemia
metabolic syndrome
yeast red
berberine
policosanol
astaxanthin
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
Collaborators: name: Centro Tecnológico de Nutrición y Salud
First posted: 2012-03-23
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)

Detailed description: Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma.

Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.

Eligibility criteria: Inclusion Criteria:

* Adult patients \> 18 years old
* LDL-c plasma levels ≥130 mg/dL and ≤ 189 mg/dL
* Patients not requiring lipid-lowering drug treatment according to ATPIII guidelines,that do not have cardiovascular disease, stroke or intermittent claudication, diabetes mellitus, renal or Patients who have demonstrated effects or contraindications to lipid-lowering drug therapy (in this case, treatment should be discontinued 1 month before baseline.
* Signed and dated informed consent before any study specific procedure.

Exclusion Criteria:

* Patients on drug therapy to reduce LDL-C, for example, statins, bile acid sequestrants, nicotinic acid, fibrates or similar (up to 1 month before baseline).
* History of cardiovascular disease, stroke or intermittent claudication.
* Diabetes mellitus (at least 2 blood fasting glucose greater than 126 mg / dL).
* Having taken any functional food with sterols, stanols or similar or any nutraceutical with lipid-lowering effects during the previous 7 days.
* Plasma levels of triglycerides \> 350 mg/dl
* Diagnosis of familial hypercholesterolemia

Primary outcomes:
measure: investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL.
timeFrame: twelve weeks
Secondary outcomes:
measure: Cardiovascular risk (according to the Framingham tables).
timeFrame: twelve weeks
measure: Criteria for Metabolic Syndrome
timeFrame: twelve weeks
measure: Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).
timeFrame: twelve weeks
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hosp. Universitario San Joan
state: Tarragona
Study officials:
affiliation: Hosp. Universitari Sant Joan de Reus (Tarragona)
name: Rosa Solà, MD PhD
role: STUDY_DIRECTOR
affiliation: Hosp. Universitario Gregorio Marañón (Madrid)
name: Jesús Millán, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. Universitario La Fe (Valencia)
name: José R Calabuig, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. Universitario Virgen del Rocío (Sevilla)
name: José Villar, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. Universitario San Jorge (Huesca)
name: José Puzo, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosp. Universitario San Pedro ( Logroño)
name: Angel Brea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sola R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Morina D, Villar J, Millan J, Anguera A. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 2014 Aug 1;9(8):e101978. doi: 10.1371/journal.pone.0101978. eCollection 2014.