NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

University Of Perugia26 enrolled

Overview

The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical inflammation and arterial stiffness were investigated in human immunodeficiency virus (HIV)-infected patients receiving stable antiretroviral therapy (ART).

This is a crossover interventional study of 26 HIV-infected patients on stable ART with low density lipoprotein cholesterol (LDL-C) \>100 mg/dL, not receiving any lipid-lowering treatment. After a 3-week lipid stabilization period with a standardized diet regimen, the effect of a 3-month oral NC containing red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg vs no active treatment (noNC) was tested on plasma total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), triglyceride, lipoprotein(a), PCSK9, high-sensitivity C-reactive protein (hsCRP) levels and aortic pulse wave velocity (aPWV).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypercholesterolemia Inflammation Atherosclerosis

Interventions

Nutraceutical combination (NC)DIETARY_SUPPLEMENT

An oral NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day was administered for 3 months along with prosecution of standardized diet regimen

No nutraceutical combination (noNC)BEHAVIORAL

Prosecution of standardized diet regimen for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * LDL-C \>100 mg/dL * no history of cardiovascular disease * stable ART for at least 6 months Exclusion Criteria: * current or recent (≤6 months) treatment with lipid-lowering drugs * chronic kidney disease \[estimated glomerular filtration rate (GFR) \<60 ml/min\] * liver impairment (AST and/or ALT \>3 times upper limit of normal) * current pregnancy * opportunistic infections within the past 3 months, * having received an organ transplant/immunosuppressive therapy

Outcomes

Primary Outcomes

Change from baseline in LDL-C levels at 3 months

plasma LDL-C levels

Time frame: 3 months after treatment randomization

Secondary Outcomes

Change from baseline in PCSK9 levels at 3 months

plasma PCSK9 levels

Time frame: 3 months after treatment randomization

Change from baseline in subclinical inflammation at 3 months

plasma hs-CRP levels

Time frame: 3 months after treatment randomization

Change from baseline in arterial stiffness at 3 months

aPWV

Time frame: 3 months after treatment randomization

Data from ClinicalTrials.gov

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