NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients
NCT03470376 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2018-03-23
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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