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The Role of a Combination of Nutraceuticals in the Control of Cardiovascular Risk (ARMOPREVCVR)

This study has been completed.
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University Identifier:
First received: February 9, 2011
Last updated: February 2, 2016
Last verified: February 2016

Cardiovascular risk has been shown to increase with increasing blood pressure values. As a consequence, it results mandatory to achieve lower blood pressure goals in all hypertensive patients, taking into account that all drugs always have some side effects that can be very dangerous and/or uncomfortable for the patients leading to a reduced compliance. Thus, pharmacological treatment should be delayed until it results really necessary.

The availability of natural substances with a therapeutic action has modified this scenario because of their reduced potential to cause undesirable effects (compared with drugs). In order to choose among various nutraceuticals (natural foods compounds with health benefits, including the prevention and/or treatment of diseases), preference should be given to those

  • produced according to the same Good Manufacturing Practice used for drugs, to be sure that the finished product has a standard, reproducible composition
  • for which efficacy and safety in the recommended indications are supported by clinical trials.

An example of a product with these characteristics is Armolipid Plus, a combination of nutraceuticals with a demonstrated anti-dyslipidaemic effect. Recently, a large clinical intervention study showed evidence that treatment with Armolipid Plus leads to a significant decrease in the overall cardiovascular risk, measured using the Framingham Risk Score.

Progress in Research and Development in this field has led to a new patented and registered combination of nutraceuticals: Armolipid Prev, containing orthosiphon and CoQ10, with antihypertensive activity, berberine, red yeast, policosanol and orthosiphon with antidyslipidaemic effect and folic acid, reducing plasma homocysteine levels.

In addition to the established anti-dyslipidaemic activity of Armolipid plus, Armolipid Prev has a significant antihypertensive effect, which is beneficial in all those patients with high blood pressure values without a defined indication to begin a pharmacological treatment according to the current guidelines. The antihypertensive effect of Armolipid Prev, documented by ambulatory blood pressure monitoring, in addition to the lowering effect on dyslipidaemia and even on abdominal girth, represents a new opportunity for complete and early, effective and safe cardiovascular disease prevention.

Condition Intervention Phase
Metabolic Syndrome
Drug: Armolipid Prev
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study on the Role of a Combination of Nutraceuticals (Armolipid Prev) With an Effect on Blood Pressure and Lipids in the Control of Cardiovascular Risk

Resource links provided by NLM:

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Cardiovascular risk [ Time Frame: 12 months ]

    Reduction the global cardiovascular risk calculated according to Framingham risk score compared to baseline.

    Reduction of incident metabolic syndrome defined according to ATPIII criteria compared to baseline.

    Reduction of the prevalence of microalbuminuria evaluated by standard methods compared to baseline.

    Reduction of the prevalence of left ventricular hypertrophy evaluated by the ECG using the current ECG criteria (the Sokolow-Lyon index) compared to baseline.

Secondary Outcome Measures:
  • Life style [ Time Frame: 12 months ]
    Increasing compliance with a healthy lifestyle assessed by office interview of the patients at baseline and at the end of follow-up

Enrollment: 150
Study Start Date: September 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
placebo Drug: Armolipid Prev
Ortosiphon 300 mg/die, CoQ10 15 mg/die, Berberine 500 mg/die, red yeast 60 mg/die, policosanol 10 mg/die, Folic acid 200 mg/die
Other Names:
  • orthosiphon
  • CoQ10
  • berberine
  • red yeast
  • policosanol
  • folic acid

  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Metabolic syndrome

Inclusion Criteria:

  • Patients with diagnosis of metabolic syndrome and requiring a blood pressure reduction without any indication to start a pharmacological therapy or in whom stable drug therapy has not achieved the desired results
  • The presence of at least 3 of the following 5 factors:

    • increased blood pressure (≥ 130/85 and ≤ 140/90 mmHg)
    • serum triglycerides ³150 mg/dL
    • serum HDL cholesterol ≤ 40 mg/dL (males), ≤ 50 mg/dL (females)
    • abdominal girth ≥ 104 cm (males), ≥ 88 cm (females)
    • elevated fasting blood glucose ≥ 100 mg/dL

Exclusion Criteria:

  • Diabetics or hypertensive subjects with an indication to start a pharmacological therapy
  • Patients under lipid-lowering treatment
  • Pregnant or breast-feeding women according to the Package Leaflet

Patients who require cholesterol-lowering drug therapy in accordance with the international guidelines will not be included in the study population

  Contacts and Locations
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Please refer to this study by its identifier: NCT01293162

Ambulatorio Ipertensione e Unità Coronarica Federico II University
Napoli, Italy, 80131
Sponsors and Collaborators
Federico II University
Study Director: Bruno Trimarco, MD Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascoalri ed Immunologiche
  More Information

Additional Information:
Responsible Party: Bruno Trimarco, Full Professor of Cardiology, Federico II University Identifier: NCT01293162     History of Changes
Other Study ID Numbers: ARMOPREV-2011
Study First Received: February 9, 2011
Last Updated: February 2, 2016

Keywords provided by Federico II University:
Metabolic syndrome
Cardiovascular risk

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Folic Acid
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Platelet Aggregation Inhibitors
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on April 27, 2017