NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

NCT03470376 | Completed Phase 4

• 1 other identifier: 2015-006
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hypercholesterolemia; Inflammation; Atherosclerosis

Keywords

cholesterol; nutraceutical; HIV; PCSK9; hsCRP; stiffness

Outcome Measures

Primary Outcomes (1)

• Change from baseline in LDL-C levels at 3 months

  plasma LDL-C levels

  3 months after treatment randomization

Secondary Outcomes (3)

• Change from baseline in PCSK9 levels at 3 months

  3 months after treatment randomization

• Change from baseline in subclinical inflammation at 3 months

  3 months after treatment randomization

• Change from baseline in arterial stiffness at 3 months

  3 months after treatment randomization

Other Outcomes (5)

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

  3 months after treatment randomization

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

  3 months after treatment randomization

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

  3 months after treatment randomization

Study Arms (2)

Nutraceutical combination (NC)

EXPERIMENTAL

Patients on standardized diet regimen taking a 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 for 3 months

Dietary Supplement: Nutraceutical combination (NC)

No nutraceutical combination (noNC)

ACTIVE COMPARATOR

Patients on standardized diet regimen without taking any NC

Behavioral: No nutraceutical combination (noNC)

Interventions

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

Also known as: Armolipid Plus, Meda Pharma - Mylan

Nutraceutical combination (NC)

No nutraceutical combination (noNC) BEHAVIORAL

Prosecution of standardized diet regimen for 3 months

No nutraceutical combination (noNC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-C \>100 mg/dL
• no history of cardiovascular disease
• stable ART for at least 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University Of Perugia: lead

Related Publications (10)

• 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.

  PMID: 25169560 BACKGROUND

• 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.

  PMID: 29067253 BACKGROUND

• 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. doi: 10.2174/1570161114666160106151652.

  PMID: 26733388 BACKGROUND

• 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.

  PMID: 27956024 BACKGROUND

• 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.

  PMID: 27004462 BACKGROUND

• 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.

  PMID: 27998714 BACKGROUND

• Pirro M, Mannarino MR, Bianconi V, Simental-Mendia 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.

  PMID: 27157250 BACKGROUND

• 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. doi: 10.1016/s0899-9007(01)00688-8.

  PMID: 11844656 BACKGROUND

• 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. doi: 10.1016/j.jacc.2007.01.083. Epub 2007 May 4.

  PMID: 17512355 BACKGROUND

• Pirro M, Francisci D, Bianconi V, Schiaroli E, Mannarino MR, Barsotti F, Spinozzi A, Bagaglia F, Sahebkar A, Baldelli F. NUtraceutical TReatment for hYpercholesterolemia in HIV-infected patients: The NU-TRY(HIV) randomized cross-over trial. Atherosclerosis. 2019 Jan;280:51-57. doi: 10.1016/j.atherosclerosis.2018.11.026. Epub 2018 Nov 14.

  PMID: 30471555 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Inflammation; Atherosclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Matteo Pirro, M.D., PhD

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients names and allocation to arms was masked for outcomes assessors
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Model Details: NC vs noNC

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: January 15, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 30, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03