NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

Inflammation Clinical Trial

— NU-TRY(HIV)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470376
• Other study ID #: 2015-006
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2018
• Last updated: March 21, 2018
• Start date: January 15, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: March 2018
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 30, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Hypercholesterolemia
• Inflammation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

References & Publications (9)

Barrios V, Escobar C, Cicero AF, Burke D, Fasching P, Banach M, Bruckert E. A nutraceutical approach (Armolipid Plus) to reduce total and LDL cholesterol in individuals with mild to moderate dyslipidemia: Review of the clinical evidence. Atheroscler Suppl. 2017 Feb;24:1-15. doi: 10.1016/j.atherosclerosissup.2016.10.003. Epub 2016 Dec 18. Review. — View Citation

Bednasz C, Luque AE, Zingman BS, Fischl MA, Gripshover BM, Venuto CS, Gu J, Feng Z, DiFrancesco R, Morse GD, Ma Q. Lipid-Lowering Therapy in HIV-Infected Patients: Relationship with Antiretroviral Agents and Impact of Substance-Related Disorders. Curr Vasc Pharmacol. 2016;14(3):280-7. — View Citation

Chastain DB, Stover KR, Riche DM. Evidence-based review of statin use in patients with HIV on antiretroviral therapy. J Clin Transl Endocrinol. 2017 Feb 22;8:6-14. doi: 10.1016/j.jcte.2017.01.004. eCollection 2017 Jun. Review. — View Citation

Keithley JK, Swanson B, Sha BE, Zeller JM, Kessler HA, Smith KY. A pilot study of the safety and efficacy of cholestin in treating HIV-related dyslipidemia. Nutrition. 2002 Feb;18(2):201-4. — View Citation

Kelesidis T, Currier JS. Dyslipidemia and cardiovascular risk in human immunodeficiency virus infection. Endocrinol Metab Clin North Am. 2014 Sep;43(3):665-84. doi: 10.1016/j.ecl.2014.06.003. Review. — View Citation

Kinlay S. Low-density lipoprotein-dependent and -independent effects of cholesterol-lowering therapies on C-reactive protein: a meta-analysis. J Am Coll Cardiol. 2007 May 22;49(20):2003-9. Epub 2007 May 4. — View Citation

Pirro M, Mannarino MR, Bianconi V, Simental-Mendía LE, Bagaglia F, Mannarino E, Sahebkar A. The effects of a nutraceutical combination on plasma lipids and glucose: A systematic review and meta-analysis of randomized controlled trials. Pharmacol Res. 2016 Aug;110:76-88. doi: 10.1016/j.phrs.2016.04.021. Epub 2016 May 6. Review. — View Citation

Pirro M, Mannarino MR, Ministrini S, Fallarino F, Lupattelli G, Bianconi V, Bagaglia F, Mannarino E. Effects of a nutraceutical combination on lipids, inflammation and endothelial integrity in patients with subclinical inflammation: a randomized clinical trial. Sci Rep. 2016 Mar 23;6:23587. doi: 10.1038/srep23587. — View Citation

Pirro M, Vetrani C, Bianchi C, Mannarino MR, Bernini F, Rivellese AA. Joint position statement on "Nutraceuticals for the treatment of hypercholesterolemia" of the Italian Society of Diabetology (SID) and of the Italian Society for the Study of Arteriosclerosis (SISA). Nutr Metab Cardiovasc Dis. 2017 Jan;27(1):2-17. doi: 10.1016/j.numecd.2016.11.122. Epub 2016 Nov 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in creatine phosphokinase (CPK) levels at 3 months	plasma CPK levels	3 months after treatment randomization
Other	Change from baseline in aspartate transaminase (AST) levels at 3 months	plasma AST levels	3 months after treatment randomization
Other	Change from baseline in alanine transaminase (ALT) levels at 3 months	plasma ALT levels	3 months after treatment randomization
Other	Change from baseline in CD4+ cell count at 3 months	CD4+ cell count	3 months after treatment randomization
Other	Change from baseline in HIV-1 RNA levels at 3 months	HIV-1 RNA levels	3 months after treatment randomization
Primary	Change from baseline in LDL-C levels at 3 months	plasma LDL-C levels	3 months after treatment randomization
Secondary	Change from baseline in PCSK9 levels at 3 months	plasma PCSK9 levels	3 months after treatment randomization
Secondary	Change from baseline in subclinical inflammation at 3 months	plasma hs-CRP levels	3 months after treatment randomization
Secondary	Change from baseline in arterial stiffness at 3 months	aPWV	3 months after treatment randomization