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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293162
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : February 3, 2016
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University

Brief Summary:

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 or disease Intervention/treatment
Metabolic Syndrome Drug: Armolipid Prev

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 150 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01293162

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

Additional Information:
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Responsible Party: Bruno Trimarco, Full Professor of Cardiology, Federico II University Identifier: NCT01293162     History of Changes
Other Study ID Numbers: ARMOPREV-2011
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by Bruno Trimarco, Federico II University:
Metabolic syndrome
Cardiovascular risk
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Platelet Aggregation Inhibitors