Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

University Of Perugia

Status and phase: Completed; Phase 4

Conditions: Inflammation; Hypercholesterolemia; Atherosclerosis

Treatments: Dietary Supplement: Nutraceutical Combination; Other: Placebo; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02422927

UPerugia01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Standard of Care + Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Standard of Care

Other: Placebo

Nutraceutical combination

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care

Dietary Supplement: Nutraceutical Combination