NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2017-11-30

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).

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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).

Conditions

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Hypercholesterolemia Inflammation Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

NC vs noNC

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Patients names and allocation to arms was masked for outcomes assessors

Study Groups

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Nutraceutical combination (NC)

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

Group Type EXPERIMENTAL

Nutraceutical combination (NC)

Intervention Type 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)

Patients on standardized diet regimen without taking any NC

Group Type ACTIVE_COMPARATOR

No nutraceutical combination (noNC)

Intervention Type BEHAVIORAL

Prosecution of standardized diet regimen for 3 months

Interventions

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Nutraceutical combination (NC)

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

Intervention Type DIETARY_SUPPLEMENT

No nutraceutical combination (noNC)

Prosecution of standardized diet regimen for 3 months

Intervention Type BEHAVIORAL

Other Intervention Names

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Armolipid Plus, Meda Pharma - Mylan

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No