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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014