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HypercholesterolemiaPhase 4NU-TRY(HIV)NCT03470376

NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients

A Phase 4 study testing Nutraceutical combination (NC) and No nutraceutical combination (noNC) in people with Hypercholesterolemia and Inflammation, run by University Of Perugia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Nutraceutical combination (NC) and No nutraceutical combination (noNC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
15 Jan 2017to 30 Nov 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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).

Read the 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).

Being tested
Nutraceutical combination (NC), No nutraceutical combination (noNC)
Keywords
cholesterol, nutraceutical, HIV, PCSK9, hsCRP, stiffness
Medical subject headings
Hypercholesterolemia, Inflammation, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutraceutical combination (NC)Dietary supplement

    Also called Armolipid Plus, Meda Pharma - Mylan

    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

  • No nutraceutical combination (noNC)Behavioural

    Prosecution of standardized diet regimen for 3 months

Study groups in NCT03470376
Study groupRoleWhat they receive
Nutraceutical combination (NC)ExperimentalPatients 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
Receives: Dietary Supplement: Nutraceutical combination (NC)
No nutraceutical combination (noNC)Active comparatorPatients on standardized diet regimen without taking any NC
Receives: Behavioral: No nutraceutical combination (noNC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in LDL-C levels at 3 months

    plasma LDL-C levels

    Measured: 3 months after treatment randomization

Secondary outcomes (3)

  1. Change from baseline in PCSK9 levels at 3 months

    plasma PCSK9 levels

    Measured: 3 months after treatment randomization

  2. Change from baseline in subclinical inflammation at 3 months

    plasma hs-CRP levels

    Measured: 3 months after treatment randomization

  3. Change from baseline in arterial stiffness at 3 months

    aPWV

    Measured: 3 months after treatment randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start15 Jan 2017
  3. Primary completion15 Nov 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
NC vs noNC
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03470376
Sponsor's protocol ID
2015-006
Acronym
NU-TRY(HIV)
Status last verified
Mar 2018
First submitted
12 Mar 2018
Last updated
23 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25169560

  • 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.

    PubMed 29067253

  • 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.

    PubMed 26733388

  • 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.

    PubMed 27956024

  • 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.

    PubMed 27004462

  • 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.

    PubMed 27998714

  • 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.

    PubMed 27157250

  • 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.

    PubMed 11844656

  • 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.

    PubMed 17512355

  • 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.

    PubMed 30471555

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nutraceutical combination (NC) and No nutraceutical combination (noNC) in people with Hypercholesterolemia and Inflammation, run by University Of Perugia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in LDL-C levels at 3 months (time frame: 3 months after treatment randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03470376, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.

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