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Trial record 57 of 228 for:    yeast

NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients (NU-TRY(HIV))

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ClinicalTrials.gov Identifier: NCT03470376
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Matteo Pirro, University Of Perugia

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).

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Inflammation Atherosclerosis Dietary Supplement: Nutraceutical combination (NC) Behavioral: No nutraceutical combination (noNC) Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: NC vs noNC
Masking: Single (Outcomes Assessor)
Masking Description: Patients names and allocation to arms was masked for outcomes assessors
Primary Purpose: Treatment
Official Title: Lipid-lowering and Vascular Effects of a Nutraceutical Combination in HIV-infected Patients on Stable Antiretroviral Therapy
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutraceutical combination (NC)
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)
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
Other Name: Armolipid Plus, Meda Pharma - Mylan

Active Comparator: No nutraceutical combination (noNC)
Patients on standardized diet regimen without taking any NC
Behavioral: No nutraceutical combination (noNC)
Prosecution of standardized diet regimen for 3 months




Primary Outcome Measures :
  1. Change from baseline in LDL-C levels at 3 months [ Time Frame: 3 months after treatment randomization ]
    plasma LDL-C levels


Secondary Outcome Measures :
  1. Change from baseline in PCSK9 levels at 3 months [ Time Frame: 3 months after treatment randomization ]
    plasma PCSK9 levels

  2. Change from baseline in subclinical inflammation at 3 months [ Time Frame: 3 months after treatment randomization ]
    plasma hs-CRP levels

  3. Change from baseline in arterial stiffness at 3 months [ Time Frame: 3 months after treatment randomization ]
    aPWV


Other Outcome Measures:
  1. Change from baseline in creatine phosphokinase (CPK) levels at 3 months [ Time Frame: 3 months after treatment randomization ]
    plasma CPK levels

  2. Change from baseline in aspartate transaminase (AST) levels at 3 months [ Time Frame: 3 months after treatment randomization ]
    plasma AST levels

  3. Change from baseline in alanine transaminase (ALT) levels at 3 months [ Time Frame: 3 months after treatment randomization ]
    plasma ALT levels

  4. Change from baseline in CD4+ cell count at 3 months [ Time Frame: 3 months after treatment randomization ]
    CD4+ cell count

  5. Change from baseline in HIV-1 RNA levels at 3 months [ Time Frame: 3 months after treatment randomization ]
    HIV-1 RNA levels



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470376


Sponsors and Collaborators
University Of Perugia
Investigators
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Principal Investigator: Matteo Pirro, M.D., PhD University of Perugia, Italy

Publications:

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Responsible Party: Matteo Pirro, Clinical Professor, Principal Investigator, University Of Perugia
ClinicalTrials.gov Identifier: NCT03470376     History of Changes
Other Study ID Numbers: 2015-006
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Keywords provided by Matteo Pirro, University Of Perugia:
cholesterol
nutraceutical
HIV
PCSK9
hsCRP
stiffness
Additional relevant MeSH terms:
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Red yeast rice
Atherosclerosis
Hypercholesterolemia
Inflammation
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Coenzyme Q10
Policosanol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Platelet Aggregation Inhibitors