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

Sponsor

Rottapharm Spain (Industry)

Overall Status

Completed

CT.gov ID

NCT01562080

Collaborator

Centro Tecnológico de Nutrición y Salud (Other)

118

Enrollment

Location

Arms

Duration (Months)

13.1

Patients Per Site Per Month

Study Details

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)

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dietary supplement red yeast, astaxanthin, berberine, policosanol, coenzyme Q10, folic acid	Dietary Supplement: Armolipid Plus one tablet per day during 12 weeks
Placebo Comparator: microcrystalline cellulose	Dietary Supplement: placebo one tablet per day during 12 weeks

Arm

Intervention/Treatment

Experimental: Dietary supplement

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

Dietary Supplement: Armolipid Plus

one tablet per day during 12 weeks

Placebo Comparator: microcrystalline cellulose

Dietary Supplement: placebo

one tablet per day during 12 weeks

Outcome Measures

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. [twelve weeks]

Secondary Outcome Measures

Cardiovascular risk (according to the Framingham tables). [twelve weeks]
Criteria for Metabolic Syndrome [twelve weeks]
Levels of triglycerides and cholesterol high density lipoprotein (HDL-C). [twelve weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)