Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

NCT02422927 | Completed Phase 4

• 1 other identifier: UPerugia01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).

Conditions

Atherosclerosis; Inflammation; Hypercholesterolemia

Keywords

C-Reactive Protein; Endothelial Microparticles; Endothelium; Nutraceutical; Cholesterol

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in LDL cholesterol at 3 months

  3 months after treatment randomization

Secondary Outcomes (2)

• Change from Baseline in Circulating endothelial microparticles at 3 months

  3 months after treatment randomization

• Change from Baseline in C-reactive protein at 3 months

  3 months after treatment randomization

Study Arms (2)

Standard of Care + Placebo

PLACEBO COMPARATOR

low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo

Other: Standard of Care; Other: Placebo

Nutraceutical combination

ACTIVE COMPARATOR

low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination

Dietary Supplement: Nutraceutical Combination; Other: Standard of Care

Interventions

Nutraceutical Combination DIETARY_SUPPLEMENT

red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily

Also known as: Armolipid Plus, Rottapharm-Madaus

Nutraceutical combination

Standard of Care OTHER

low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule

Nutraceutical combination; Standard of Care + Placebo

Placebo OTHER

placebo

Standard of Care + Placebo

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL cholesterol \<160 mg/dl (4,14 mmol/l);
• hsCRP \>2 mg/L;

You may not qualify if:

• triglycerides \>500 mg/dL (5.6 mmol/L);
• current or previous treatment with lipid-lowering drugs or with other drugs supposed to modify vascular damage and/or repair (antiplatelet, anti-hypertensive and antioxidant drugs);
• current or previous treatment with hormone replacement therapy for menopause vasomotor symptoms;
• evidence of liver dysfunction or alanine-aminotransferase (ALT) levels twice above the upper normal limit;
• creatin-kinase (CK) levels thrice above the upper normal limit
• history or clinical evidence of previous or current cardiovascular disease;
• presence of strong cardiovascular risk factors such as: serum creatinine levels \>2 mg/dL, diabetes mellitus, uncontrolled systemic arterial hypertension (systolic blood pressure \>190 mg/dL or diastolic blood pressure \>100 mg/dL); history of cancer in the former 5 years before recruitment; not adequately treated hypothyroidism (TSH levels \>1,5 times the upper normal limit);
• history of malignancy in the previous 5 years before screening;
• not adequately treated hypothyroidism (TSH levels \>1,5 times the upper normal limit);
• previous or current alcohol or drugs abuse;
• history or clinical evidence of chronic inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory bowel disease;
• current or previous use of immunosuppressant agents or long term glucocorticoids
• history or clinical evidence of any severe concomitant disease which may compromise subject's safety or its possibility to carry out the study.

Sponsors & Collaborators

• University Of Perugia: lead

Related Publications (9)

• McGorrian C, Yusuf S, Islam S, Jung H, Rangarajan S, Avezum A, Prabhakaran D, Almahmeed W, Rumboldt Z, Budaj A, Dans AL, Gerstein HC, Teo K, Anand SS; INTERHEART Investigators. Estimating modifiable coronary heart disease risk in multiple regions of the world: the INTERHEART Modifiable Risk Score. Eur Heart J. 2011 Mar;32(5):581-9. doi: 10.1093/eurheartj/ehq448. Epub 2010 Dec 22.

  PMID: 21177699 BACKGROUND

• Pirro M, Bergeron J, Dagenais GR, Bernard PM, Cantin B, Despres JP, Lamarche B. Age and duration of follow-up as modulators of the risk for ischemic heart disease associated with high plasma C-reactive protein levels in men. Arch Intern Med. 2001 Nov 12;161(20):2474-80. doi: 10.1001/archinte.161.20.2474.

  PMID: 11700160 BACKGROUND

• Gerli R, Sherer Y, Vaudo G, Schillaci G, Gilburd B, Giordano A, Bocci EB, Allegrucci R, Marchesi S, Mannarino E, Shoenfeld Y. Early atherosclerosis in rheumatoid arthritis: effects of smoking on thickness of the carotid artery intima media. Ann N Y Acad Sci. 2005 Jun;1051:281-90. doi: 10.1196/annals.1361.069.

  PMID: 16126969 BACKGROUND

• Gerli R, Vaudo G, Bocci EB, Schillaci G, Alunno A, Luccioli F, Hijazi R, Mannarino E, Shoenfeld Y. Functional impairment of the arterial wall in primary Sjogren's syndrome: combined action of immunologic and inflammatory factors. Arthritis Care Res (Hoboken). 2010 May;62(5):712-8. doi: 10.1002/acr.20117.

  PMID: 20191479 BACKGROUND

• St-Pierre AC, Cantin B, Bergeron J, Pirro M, Dagenais GR, Despres JP, Lamarche B. Inflammatory markers and long-term risk of ischemic heart disease in men A 13-year follow-up of the Quebec Cardiovascular Study. Atherosclerosis. 2005 Oct;182(2):315-21. doi: 10.1016/j.atherosclerosis.2005.02.009.

  PMID: 16159604 BACKGROUND

• Ridker PM, Rifai N, Clearfield M, Downs JR, Weis SE, Miles JS, Gotto AM Jr; Air Force/Texas Coronary Atherosclerosis Prevention Study Investigators. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med. 2001 Jun 28;344(26):1959-65. doi: 10.1056/NEJM200106283442601.

  PMID: 11430324 BACKGROUND

• Pirro M, Schillaci G, Paltriccia R, Bagaglia F, Menecali C, Mannarino MR, Capanni M, Velardi A, Mannarino E. Increased ratio of CD31+/CD42- microparticles to endothelial progenitors as a novel marker of atherosclerosis in hypercholesterolemia. Arterioscler Thromb Vasc Biol. 2006 Nov;26(11):2530-5. doi: 10.1161/01.ATV.0000243941.72375.15. Epub 2006 Aug 31.

  PMID: 16946129 BACKGROUND

• Pirro M, Schillaci G, Bagaglia F, Menecali C, Paltriccia R, Mannarino MR, Capanni M, Velardi A, Mannarino E. Microparticles derived from endothelial progenitor cells in patients at different cardiovascular risk. Atherosclerosis. 2008 Apr;197(2):757-67. doi: 10.1016/j.atherosclerosis.2007.07.012. Epub 2007 Aug 27.

  PMID: 17720166 BACKGROUND

• Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):656-61. doi: 10.1016/j.numecd.2009.05.017. Epub 2009 Aug 20.

  PMID: 19699071 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Inflammation; Hypercholesterolemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Matteo Pirro, MD, PhD

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 22, 2015
• Study Start: July 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 22, 2015

Record last verified: 2015-04