Nutraceuticals to Improve Lipid Profile in European Countries

NCT01649986 | Unknown Phase 4

• 1 other identifier: 450/2012/D
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia; Non-pharmacologic prevention

Outcome Measures

Primary Outcomes (1)

• Evaluation of treatment tolerability

  Reasons for treatment discontinuation

  Up to 12 months

Secondary Outcomes (1)

• Evaluation of drug effects on lipid and metabolic features

  Up to 12 months

Study Arms (2)

Non-pharmacologic intervention

ACTIVE COMPARATOR

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

Nutraceuticals

ACTIVE COMPARATOR

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)

Interventions

Non-pharmacologic intervention BEHAVIORAL

Diet and physical exercise

Also known as: Hypolipidemic non-pharmacologic intervention

Non-pharmacologic intervention

Nutraceuticals (Armolipid Plus) 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,

Also known as: Armolipid Plus, Rottapharm, Italy

Nutraceuticals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University

Rome, 00166, Italy

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Francesco Pelliccia, MD

  Sapienza University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

IT (1)