NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Lipid-lowering and Vascular Effects of a Nutraceutical Combination in HIV-infected Patients on Stable Antiretroviral Therapy

Conditions
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Hypercholesterolemia, Inflammation, Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: Nutraceutical combination (NC)
* Behavioral: No nutraceutical combination (noNC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: NC vs noNC
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutraceutical combination (NC)<br>Patients on standardized diet regimen taking a 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 for 3 months | Dietary Supplement: Nutraceutical combination (NC)<br>* 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<br>* Other names: Armolipid Plus, Meda Pharma - Mylan;|
| Active Comparator: No nutraceutical combination (noNC)<br>Patients on standardized diet regimen without taking any NC | Behavioral: No nutraceutical combination (noNC)<br>* Prosecution of standardized diet regimen for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LDL-C levels at 3 months | plasma LDL-C levels | 3 months after treatment randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PCSK9 levels at 3 months | plasma PCSK9 levels | 3 months after treatment randomization | 
| Change from baseline in subclinical inflammation at 3 months | plasma hs-CRP levels | 3 months after treatment randomization | 
| Change from baseline in arterial stiffness at 3 months | aPWV | 3 months after treatment randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, nutraceutical, HIV, PCSK9, hsCRP, stiffness