NCT01649986

Nutraceuticals to Improve Lipid Profile in European Countries

Additive Effects of Nutraceuticals to Non-pharmacologic Intervention to Improve Lipid Profile in the Real World Clinical Practice in European Countries - The PIN (Portugul Italy Nutraceutical) Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Non-pharmacologic intervention	Diet and physical exercise
DRUG	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,

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2012-07-25
• Last updated: 2013-03-07

Locations

1 site across 1 country: Italy