Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

Phase 4

Completed

• Conditions: Inflammation; Hypercholesterolemia; Atherosclerosis
• Interventions: Other: Standard of Care; Dietary Supplement: Nutraceutical Combination; Other: Placebo

• Registration Number: NCT02422927
• Lead Sponsor: University Of Perugia

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).

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 Timeline

• Study Start: 2014-07
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Status Verified: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-16
• Last Update Submitted: 2015-04-16
• Study First Posted: 2015-04-22
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care + Placebo	Standard of Care	low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo
Standard of Care + Placebo	Placebo	low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo
Nutraceutical combination	Nutraceutical Combination	low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination
Nutraceutical combination	Standard of Care	low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination

Primary Outcome Measures

Name	Time	Method
Change from Baseline in LDL cholesterol at 3 months	3 months after treatment randomization

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in C-reactive protein at 3 months	3 months after treatment randomization
Change from Baseline in Circulating endothelial microparticles at 3 months	3 months after treatment randomization