Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

Inflammation Clinical Trial

Official title:

Effect of a Nutraceutical Combination on Endothelial Injury and C-reactive Protein in Patients With Low-grade Systemic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422927
• Other study ID #: UPerugia01
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2015
• Last updated: April 16, 2015
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Description:

Will be included in the study 100 subjects with suboptimal LDL cholesterol levels (LDL 100-160 mg / dL) and hsCRP levels> 2 mg / L, divided into two groups of equal numbers, matched by by sex and age, randomized to receive a nutraceutical combination containing red yeast 200 mg, berberine 500 mg and policosanol 10 mg (NC) in combination with a low-cholesterol diet (<200 mg / day) or a low-cholesterol diet only (Standard of Care - SOC).

All subjects at the time of inclusion in the study protocol will be prescribed the SOC for a period of 30 days (Lipid Stabilization Period: LSP); After 30 days LSP it will be performed randomization in the two intervention arms: NC + SOC or SOC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• LDL cholesterol <160 mg/dl (4,14 mmol/l);

• hsCRP >2 mg/L;

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Hypercholesterolemia
• Inflammation

Intervention

Dietary Supplement:
• Nutraceutical Combination
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

Other:
• Standard of Care
low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

References & Publications (9)

Affuso F, Ruvolo A, Micillo F, Saccà 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. — View Citation

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. — View Citation

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 Sjögren's syndrome: combined action of immunologic and inflammatory factors. Arthritis Care Res (Hoboken). 2010 May;62(5):712-8. doi: 10.1002/acr.20117. — View Citation

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. — View Citation

Pirro M, Bergeron J, Dagenais GR, Bernard PM, Cantin B, Després 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. — View Citation

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. Epub 2007 Aug 27. — View Citation

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. Epub 2006 Aug 31. — View Citation

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. — View Citation

St-Pierre AC, Cantin B, Bergeron J, Pirro M, Dagenais GR, Després 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in LDL cholesterol at 3 months		3 months after treatment randomization	No
Secondary	Change from Baseline in Circulating endothelial microparticles at 3 months		3 months after treatment randomization	No
Secondary	Change from Baseline in C-reactive protein at 3 months		3 months after treatment randomization	No