Armolipid Plus and Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT01087632 |
Recruitment Status :
Completed
First Posted : March 16, 2010
Last Update Posted : September 2, 2010
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Metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues.
Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on indices of insulin resistance.
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on the diagnostic parameters of metabolic syndrome.
60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).
Primary end point will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index) and after an oral glucose tolerance test (OGTT).
Condition or disease | Intervention/treatment | Phase |
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Metabolic Syndrome | Dietary Supplement: Armolipid Plus | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |

Arm | Intervention/treatment |
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Experimental: Armolipid Plus
Armolipid Plus is an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,- policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg
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Dietary Supplement: Armolipid Plus
Armolipid Plus 1 tablet QD for 18 weeks
Other Names:
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Placebo Comparator: Placebo
Placebo matching Armolipid plus
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Dietary Supplement: Armolipid Plus
Armolipid Plus 1 tablet QD for 18 weeks
Other Names:
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- Insulin/glucose ratio after overnight fast [ Time Frame: 18 weeks ]HOMA INDEX
- Insuline/glucose ratio after an oralglucose tolerance test [ Time Frame: 18 weeks ]OGTT
- BMI [ Time Frame: 18 weeks ]evaluation of weight and BMI
- Glycemia [ Time Frame: 18 weeks ]Blood Glucose
- Endothelial function [ Time Frame: 18 weeks ]endothelial function assessed by Flow Mediated Dilation
- C reactive protein. [ Time Frame: 18 weeks ]dosage of CRP
- Serum lipidemia [ Time Frame: 18 weeks ]measure of TG and cholesterol

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm(F), and two or more of these criteria:
- fasting blood glucose >100 mg;
- systolic blood pressure >135 or diastolic blood pressure >85 mmHg or patients in treatment with antihypertensive drugs;
- triglyceridemia >150 mg/dl;
- HDL cholesterolemia < 40 mg/dl(M), < 50 mg/dl(F).
Exclusion Criteria:
- pregnancy
- diabetes mellitus in pharmacologic treatment;
- hepatic failure;
- creatininemia >2 mg/dl;
- triglyceridemia > 500 mg/dl;
- heart failure.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087632
Italy | |
Federico II University - Department of Internal Medicine | |
Naples, Italy |
Principal Investigator: | Serafino Fazio, MD | Federico II University |
Responsible Party: | Massimo D'Amato, MD, Rottapharm |
ClinicalTrials.gov Identifier: | NCT01087632 |
Other Study ID Numbers: |
ARMP-09 |
First Posted: | March 16, 2010 Key Record Dates |
Last Update Posted: | September 2, 2010 |
Last Verified: | September 2010 |
Metabolic Syndrome Insulin-resistance Endothelial Function |
Metabolic Syndrome Syndrome Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Folic Acid Coenzyme Q10 Policosanol Red yeast rice Hematinics Vitamin B Complex |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Platelet Aggregation Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |