Combined Effects of Bioactive Compounds in Lipid Profile (ARM-PLUS-LDL)
This study has been completed.
Sponsor:
Rottapharm Spain
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
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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 May 16, 2013