Nutraceuticals to Improve Lipid Profile in European Countries (PIN)

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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperlipidemia
• Intervention / Treatment: Behavioral: Non-pharmacologic intervention; Drug: Nutraceuticals (Armolipid Plus)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00166
    • Sapienza University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Non-pharmacologic intervention; Diet and physical exercise; Other Names: Hypolipidemic non-pharmacologic intervention
Active Comparator: 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,	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,; Other Names: Armolipid Plus, Rottapharm, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of treatment tolerability	Reasons for treatment discontinuation	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of drug effects on lipid and metabolic features	Effects on lipid profile (total cholesterol, LDL cholesterol, triglycerides) and metabolic indexes (glucose levels, HOMA)	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Francesco Pelliccia, MD, Sapienza University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): March 7, 2013
• Last Update Submitted That Met QC Criteria: March 6, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Hyperlipidemia; Non-pharmacologic prevention
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 450/2012/D