- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422927
Nutraceutical Combination in Patients With Low-grade Systemic Inflammation
Effect of a Nutraceutical Combination on Endothelial Injury and C-reactive Protein in Patients With Low-grade Systemic Inflammation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Standard of Care + Placebo
low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo
|
placebo
low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
|
Active Comparator: Nutraceutical combination
low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination
|
low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in LDL cholesterol at 3 months
Time Frame: 3 months after treatment randomization
|
3 months after treatment randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Circulating endothelial microparticles at 3 months
Time Frame: 3 months after treatment randomization
|
3 months after treatment randomization
|
Change from Baseline in C-reactive protein at 3 months
Time Frame: 3 months after treatment randomization
|
3 months after treatment randomization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matteo Pirro, MD, PhD, University of Perugia, Italy
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPerugia01
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