Nutraceuticals to Improve Lipid Profile in European Countries (PIN)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia |
Behavioral: Non-pharmacologic intervention Drug: Nutraceuticals (Armolipid Plus) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- Evaluation of treatment tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]Reasons for treatment discontinuation
- Evaluation of drug effects on lipid and metabolic features [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]Effects on lipid profile (total cholesterol, LDL cholesterol, triglycerides) and metabolic indexes (glucose levels, HOMA)
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2014 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Armolipid Plus, Rottapharm, Italy
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Italy | |
| Sapienza University | Recruiting |
| Rome, Italy, 00166 | |
| Contact: Francesco Pelliccia, MD +39064997 ext 123 f.pelliccia@mclink.it | |
| Principal Investigator: Francesco Pelliccia, MD | |
| Principal Investigator: | Francesco Pelliccia, MD | Sapienza University |
More Information
No publications provided
| Responsible Party: | Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01649986 History of Changes |
| Other Study ID Numbers: | 450/2012/D |
| Study First Received: | July 20, 2012 |
| Last Updated: | March 6, 2013 |
| Health Authority: | Italy: National Institute of Health |
Keywords provided by University of Roma La Sapienza:
|
Hyperlipidemia Non-pharmacologic prevention |
Additional relevant MeSH terms:
|
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013