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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Federico II University
• Treatments: Folic Acid; Policosanol

Criteria

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