Combined Effects of Bioactive Compounds in Lipid Profile (ARM-PLUS-LDL)

This study has been completed.
Sponsor:
Collaborator:
Centro Tecnológico de Nutrición y Salud
Information provided by (Responsible Party):
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT01562080
First received: March 21, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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)


Condition Intervention Phase
Hyperlipidemia
Low-density-lipoprotein-type
Elevated Triglycerides
Dietary Supplement: Armolipid Plus
Dietary Supplement: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rottapharm Spain:

Primary Outcome Measures:
  • 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. [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular risk (according to the Framingham tables). [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
  • Criteria for Metabolic Syndrome [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
  • Levels of triglycerides and cholesterol high density lipoprotein (HDL-C). [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary supplement
red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid
Dietary Supplement: Armolipid Plus
one tablet per day during 12 weeks
Other Name: Armolipid Plus
Placebo Comparator: microcrystalline cellulose Dietary Supplement: placebo
one tablet per day during 12 weeks

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562080

Locations
Spain
Hosp. Universitario San Joan
Reus, Tarragona, Spain
Sponsors and Collaborators
Rottapharm Spain
Centro Tecnológico de Nutrición y Salud
Investigators
Study Director: Rosa Solà, MD PhD Hosp. Universitari Sant Joan de Reus (Tarragona)
Principal Investigator: Jesús Millán, MD PhD Hosp. Universitario Gregorio Marañón (Madrid)
Principal Investigator: José R Calabuig, MD PhD Hosp. Universitario La Fe (Valencia)
Principal Investigator: José Villar, MD PhD Hosp. Universitario Virgen del Rocío (Sevilla)
Principal Investigator: José Puzo, MD PhD Hosp. Universitario San Jorge (Huesca)
Principal Investigator: Angel Brea, MD Hosp. Universitario San Pedro ( Logroño)
  More Information

No publications provided

Responsible Party: Rottapharm Spain
ClinicalTrials.gov Identifier: NCT01562080     History of Changes
Other Study ID Numbers: ARM-PLUS-LDL
Study First Received: March 21, 2012
Last Updated: February 27, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Rottapharm Spain:
hyperlipidemia
metabolic syndrome
yeast red
berberine
policosanol
astaxanthin

Additional relevant MeSH terms:
Hyperlipidemias
Hypertriglyceridemia
Metabolic Syndrome X
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on April 23, 2014