NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

NCT03470376 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-03-23

No results posted yet for this study

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).

Conditions

Interventions

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

BEHAVIORAL

No nutraceutical combination (noNC)

Prosecution of standardized diet regimen for 3 months

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Principal Investigators

  • Matteo Pirro, M.D., PhD · University Of Perugia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-15
Primary Completion
2017-11-15
Completion
2017-11-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470376 on ClinicalTrials.gov