The Role of a Combination of Nutraceuticals in the Control of Cardiovascular Risk

NCT01293162 | Completed DMC

• 1 other identifier: ARMOPREV-2011
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Cardiovascular risk

  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.

  12 months

Secondary Outcomes (1)

• Life style

  12 months

Study Arms (1)

placebo

Drug: Armolipid Prev

Interventions

Armolipid Prev DRUG

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

Also known as: orthosiphon, CoQ10, berberine, red yeast, policosanol, folic acid

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Metabolic syndrome

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Ambulatorio Ipertensione e Unità Coronarica Federico II University

Napoli, 80131, Italy

Location

Related Publications (1)

• Izzo R, de Simone G, Giudice R, Chinali M, Trimarco V, De Luca N, Trimarco B. Effects of nutraceuticals on prevalence of metabolic syndrome and on calculated Framingham Risk Score in individuals with dyslipidemia. J Hypertens. 2010 Jul;28(7):1482-7. doi: 10.1097/HJH.0b013e3283395208.

  PMID: 20498621 BACKGROUND

Related Links

• website of the High Blood Pressure Outpatient Clinic and UTIC of "Federico II" University of Naples

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

coenzyme Q10; Berberine; red yeast rice; policosanol; Folic Acid

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring

Study Officials

• Bruno Trimarco, MD

  Federico II University, Dipartimento di medicina Clinica Scienze Cardiovascoalri ed Immunologiche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Cardiology

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: September 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

IT (1)