Nutraceuticals to Improve Lipid Profile in European Countries

NCT ID: NCT01649986

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-12-31

Brief Summary

Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects.

In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom only non-pharmacologic intervention and prevention strategies are currently prescribed.

Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions.

The primary objective of this study is twofold:

First, to prospectively compare in the real world clinical practice the efficacy and tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic intervention with a nutraceutical-based protocol in patients in whom statin treatment is not tolerated or is not indicated.

Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a nutraceutical-based protocol among European countries.

Detailed Description

Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects.

In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom only non-pharmacologic intervention and prevention strategies are currently prescribed.

Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions.

In the real world clinical practice, however, it remains unclear if nutraceuticals yield additive therapeutic effects to non-pharmacologic intervention and prevention strategies in patients in whom statin treatment is not tolerated or is not indicated.

The primary objective of this study is twofold:

First, to prospectively compare in the real world clinical practice the efficacy and tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic intervention with a nutraceutical-based protocol in patients in whom statin treatment is not tolerated or is not indicated.

Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a nutraceutical-based protocol among European countries.

Patients will be assigned at the discretion of their own general practitioner to receive for 1 year either non-pharmacologic intervention and prevention strategies or non-pharmacologic intervention and prevention strategies associated with a commercially available nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg).

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Non-pharmacologic intervention

Patients assigned by their own general practitioner to have non-pharmacologic intervention and prevention strategies will be given details on lifestyle approaches and dietary strategies

Group Type: ACTIVE_COMPARATOR

Non-pharmacologic intervention

Intervention Type: BEHAVIORAL

Diet and physical exercise

Nutraceuticals

Patients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg,

Group Type: ACTIVE_COMPARATOR

Nutraceuticals (Armolipid Plus)

Intervention Type: DRUG

Patients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg,

Interventions

Non-pharmacologic intervention

Diet and physical exercise

Intervention Type: BEHAVIORAL

Nutraceuticals (Armolipid Plus)

Patients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg,

Intervention Type: DRUG

Other Intervention Names

Hypolipidemic non-pharmacologic intervention; Armolipid Plus, Rottapharm, Italy

Eligibility Criteria

Inclusion Criteria

• Class I indication to receive statin treatment but previous (<12 months) withdrawn of a statin due to side effects and unwilling to receive treatment with an alternative statin
• Class I indication to receive non-pharmacologic intervention and prevention strategies because of hyperlipidemia with 'low risk' classification
• Able to understand and willing to sign the informed CF

Exclusion Criteria

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pelliccia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Pelliccia, MD

Role: PRINCIPAL_INVESTIGATOR

Sapienza University

Locations

Sapienza University

Rome, , Italy

Countries

Italy

Facility Contacts

Francesco Pelliccia, MD

Role: primary

f.pelliccia@mclink.it

+39064997 ext. 123

Other Identifiers

450/2012/D

Identifier Type: -

Identifier Source: org_study_id