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

Primary Purpose

Hyperlipidemia, Low-density-lipoprotein-type, Elevated Triglycerides

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Armolipid Plus

placebo

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring hyperlipidemia, metabolic syndrome, yeast red, berberine, policosanol, astaxanthin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hosp. Universitario San Joan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dietary supplement

microcrystalline cellulose

Arm Description

red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid

Outcomes

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.

Secondary Outcome Measures

Cardiovascular risk (according to the Framingham tables).

Criteria for Metabolic Syndrome

Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).

Full Information

NCT ID

NCT01562080

First Posted

March 21, 2012

Last Updated

February 27, 2013

Sponsor

Rottapharm Spain

Collaborators

Centro Tecnológico de Nutrición y Salud

1. Study Identification

Unique Protocol Identification Number

NCT01562080

Brief Title

Combined Effects of Bioactive Compounds in Lipid Profile

Acronym

ARM-PLUS-LDL

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

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rottapharm Spain

Collaborators

Centro Tecnológico de Nutrición y Salud

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia, Low-density-lipoprotein-type, Elevated Triglycerides

Keywords

hyperlipidemia, metabolic syndrome, yeast red, berberine, policosanol, astaxanthin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dietary supplement

Arm Type

Experimental

Arm Description

red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid

Arm Title

microcrystalline cellulose

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Armolipid Plus

Intervention Description

one tablet per day during 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

one tablet per day during 12 weeks

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Cardiovascular risk (according to the Framingham tables).

Time Frame

twelve weeks

Title

Criteria for Metabolic Syndrome

Time Frame

twelve weeks

Title

Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).

Time Frame

twelve weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: