Nutraceutical in Cardiovascular Primary Prevention

NCT03216811 | Completed Phase 2 DMC

• 1 other identifier: 170598
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Nutraceuticals have attracted interest as possible approach to be associated with lifestyle changes for lowering plasma cholesterol levels in patients with moderate hypercholesterolemia. Ruscica and colleagues showed that a 8-weeks treatment with a nutraceutical combination containing red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid was able to reduce significantly total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%) \[11\]. These nutraceutical compounds exert their lipid-lowering effect through different ways, like the inhibition of the hydroxymethylglutaryl coenzyme A (CoA) enzyme, increasing the hepatic expression of low density lipoprotein (LDL) receptor and the LDL degradation via enhanced hepatic binding and internalization. In addition, they up regulate the numbers and function of circulating endothelial progenitor cells increasing nitric oxide (NO) production. The purpose of the present study was to assess the effectiveness of CARDIOVIS COLESTEROLO 3 mg (containing red rice fermented with Monascus purpureus titrated with 3% monacolin K, hydrol mixture of olive fruit titrated with vitamin E, Coenzyme Q10 and polymethoxyflavones) in terms of cholesterol, endothelial and inflammatory parameters reduction.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• LDL

  blood values of low density lipoprotein

  8 weeks

Secondary Outcomes (7)

• triglycerides

  8 weeks

• total cholesterol

  8 weeks

• oxidized LDL

  8 weeks

• HDL

  8 weeks

• rate of apoptosis

  8 weeks

Other Outcomes (1)

• creatine phosphate kinase (CPK)

  8 weeks

Study Arms (1)

nutraceutical

EXPERIMENTAL

after 4 weeks of lifestyle advice and changes, all subjects will receive for 8 weeks the administration of CARDIOVIS COLESTEROLO 3 mg, a nutraceutical compound containing containing red rice fermented with Monascus purpureus titrated with 3% monacolin K, hydrol mixture of olive fruit titrated with vitamin E, Coenzyme Q10 and polymethoxyflavones

Drug: nutraceutical

Interventions

nutraceutical DRUG

8-week administration of nutraceutical compound

nutraceutical

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years; Ability to provide informed written consent and to participate in the 16 weeks follow-up period And one of the following criteria
• Cardiovascular risk (SCORE) \<1% and LDL levels ≥ 190 mg/dl (confirmed after a 4-week period of life style changes)
• Cardiovascular risk (SCORE) 1% to \<5% and LDL levels ≥ 100 mg/dl (confirmed after a 4- week period of life style changes)

You may not qualify if:

• Chronic liver disease Renal disease (creatinine clearance \<60 mg/dl) Intolerance to nutraceutical compounds Thyroid disease Alcohol consumption \>40 g/die Treatment with lipid lowering products in the previous 4 weeks Known coronary artery disease (CAD) or cerebrovascular disease Cardiovascular risk (SCORE) ≥5%

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related Publications (1)

• Cimaglia P, Vieceli Dalla Sega F, Vitali F, Lodolini V, Bernucci D, Passarini G, Fortini F, Marracino L, Aquila G, Rizzo P, Ferrari R, Campo G. Effectiveness of a Novel Nutraceutical Compound Containing Red Yeast Rice, Polymethoxyflavones and Antioxidants in the Modulation of Cholesterol Levels in Subjects With Hypercholesterolemia and Low-Moderate Cardiovascular Risk: The NIRVANA Study. Front Physiol. 2019 Mar 11;10:217. doi: 10.3389/fphys.2019.00217. eCollection 2019.

  PMID: 30914970 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hyperlipidemias; 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

• Paolo Cimaglia, Dr

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

• Francesco Vitali, Dr

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Interventional Cardiologist

Model Details: Subjects that meet the inclusion/exclusion criteria and have provided informed consent will undergo a 4-week period of lifestyle advice and changes. If, after the 4 weeks, LDL values are confirmed above the established cutoffs, the subjects receive CARDIOVIS COLESTEROLO 3 mg for 8 weeks. After the 8-week treatment period, all biological paprameters will be reassessed. Finally, a last blood samples to assess a potential rebound effect after nutraceutical suspension is collected 4 weeks after the treatment stop.

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: July 20, 2017
• Primary Completion: October 31, 2017
• Study Completion: December 2, 2017
• Last Updated: December 5, 2017

Record last verified: 2017-12

Locations

IT (1)