NU-TRY(HIV): NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

Sponsor

University Of Perugia (Other)

Overall Status

Completed

CT.gov ID

NCT03470376

Collaborator

(none)

Enrollment

Arms

10.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Inflammation Atherosclerosis	Dietary Supplement: Nutraceutical combination (NC) Behavioral: No nutraceutical combination (noNC)	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

NC vs noNCNC vs noNC

Masking:

Single (Outcomes Assessor)

Masking Description:

Patients names and allocation to arms was masked for outcomes assessors

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 15, 2017

Actual Primary Completion Date :

Nov 15, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Dietary Supplement: 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 Other Names: Armolipid Plus, Meda Pharma - Mylan
Active Comparator: No nutraceutical combination (noNC) Patients on standardized diet regimen without taking any NC	Behavioral: No nutraceutical combination (noNC) Prosecution of standardized diet regimen for 3 months

Arm

Intervention/Treatment

Experimental: 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

Dietary Supplement: 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

Other Names:

Armolipid Plus, Meda Pharma - Mylan

Active Comparator: No nutraceutical combination (noNC)

Patients on standardized diet regimen without taking any NC

Behavioral: No nutraceutical combination (noNC)

Prosecution of standardized diet regimen for 3 months

Outcome Measures

Primary Outcome Measures

Change from baseline in LDL-C levels at 3 months [3 months after treatment randomization]
plasma LDL-C levels

Secondary Outcome Measures

Change from baseline in PCSK9 levels at 3 months [3 months after treatment randomization]
plasma PCSK9 levels
Change from baseline in subclinical inflammation at 3 months [3 months after treatment randomization]
plasma hs-CRP levels
Change from baseline in arterial stiffness at 3 months [3 months after treatment randomization]
aPWV

Other Outcome Measures

Change from baseline in creatine phosphokinase (CPK) levels at 3 months [3 months after treatment randomization]
plasma CPK levels
Change from baseline in aspartate transaminase (AST) levels at 3 months [3 months after treatment randomization]
plasma AST levels
Change from baseline in alanine transaminase (ALT) levels at 3 months [3 months after treatment randomization]
plasma ALT levels
Change from baseline in CD4+ cell count at 3 months [3 months after treatment randomization]
CD4+ cell count
Change from baseline in HIV-1 RNA levels at 3 months [3 months after treatment randomization]
HIV-1 RNA levels