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NCT Number: NCT03470376

NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

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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Key information

Conditions

Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hyperlipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Armolipid Plus, Meda Pharma - Mylan

No nutraceutical combination (noNC)

Behavioral

Prosecution of standardized diet regimen for 3 months

Primary outcomes

  1. Change from baseline in LDL-C levels at 3 months

    Time frame: 3 months after treatment randomization

    plasma LDL-C levels

Secondary outcomes

  1. Change from baseline in PCSK9 levels at 3 months

    Time frame: 3 months after treatment randomization

    plasma PCSK9 levels

  2. Change from baseline in subclinical inflammation at 3 months

    Time frame: 3 months after treatment randomization

    plasma hs-CRP levels

  3. Change from baseline in arterial stiffness at 3 months

    Time frame: 3 months after treatment randomization

    aPWV

Other outcomes

  1. Change from baseline in creatine phosphokinase (CPK) levels at 3 months

    Time frame: 3 months after treatment randomization

    plasma CPK levels

  2. Change from baseline in aspartate transaminase (AST) levels at 3 months

    Time frame: 3 months after treatment randomization

    plasma AST levels

  3. Change from baseline in alanine transaminase (ALT) levels at 3 months

    Time frame: 3 months after treatment randomization

    plasma ALT levels

  4. Change from baseline in CD4+ cell count at 3 months

    Time frame: 3 months after treatment randomization

    CD4+ cell count

  5. Change from baseline in HIV-1 RNA levels at 3 months

    Time frame: 3 months after treatment randomization

    HIV-1 RNA levels

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Registry information

Official study title

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

Acronym: NU-TRY(HIV)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2018
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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