Atherosclerosis, Inflammation, Hypercholesterolemia
Conditions
Keywords
C-Reactive Protein, Endothelial Microparticles, Endothelium, Nutraceutical, Cholesterol
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.
Interventions
DIETARY_SUPPLEMENTNutraceutical 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
OTHERStandard of Care
low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
OTHERPlacebo
placebo
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in LDL cholesterol at 3 months | 3 months after treatment randomization |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed