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

University Of Perugia

Status and phase: Completed; Phase 4

Conditions: Inflammation; Hypercholesterolemia; Atherosclerosis

Treatments: Behavioral: No nutraceutical combination (noNC); Dietary Supplement: Nutraceutical combination (NC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03470376

2015-006

Details and patient eligibility

About

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).

Full 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).

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Nutraceutical combination (NC)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nutraceutical combination (NC)

No nutraceutical combination (noNC)

Active Comparator group

Description:

Patients on standardized diet regimen without taking any NC

Treatment:

Behavioral: No nutraceutical combination (noNC)