Atherosclerosis, Hypercholesterolemia, Inflammation
Conditions
Keywords
cholesterol, nutraceutical, HIV, PCSK9, hsCRP, stiffness
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).
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).
Interventions
DIETARY_SUPPLEMENTNutraceutical 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
BEHAVIORALNo nutraceutical combination (noNC)
Prosecution of standardized diet regimen for 3 months
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Patients names and allocation to arms was masked for outcomes assessors
Intervention model description
NC vs noNC
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in LDL-C levels at 3 months | 3 months after treatment randomization | plasma LDL-C levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in creatine phosphokinase (CPK) levels at 3 months | 3 months after treatment randomization | plasma CPK levels |
| Change from baseline in HIV-1 RNA levels at 3 months | 3 months after treatment randomization | HIV-1 RNA 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 |
Outcome results
None listed