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Effects of Nutraceutical Therapies on Endothelial Function, Platelet Aggregation, and Coronary Flow Reserve (NUTRENDO)

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ClinicalTrials.gov Identifier: NCT02969070
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Bruno Trimarco, Federico II University

Brief Summary:
Hypercholesterolemia is considered one of the most important cardiovascular risk factors. Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk'. Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions. However, it remains unclear if nutraceuticals yield additive positive effects other than cholesterol lowering. In particular, there is evidence that Berberine has cardiovascular protective effects and that, in vitro, Morus Alba, mulberry fruit, modulates platelet function by inhibiting platelet activation, thromboxane formation, serotonin secretion, aggregation and thrombus formation. Furthermore, Morus Alba exerts an α-glucosidase inhibitory and antioxidant activity in vitro, which may reduce postprandial glucose peak, thus improving HbA1c concentration. Accordingly, we designated a study to evaluate the effects of two commercially available nutraceutical combined pills [LopiGLIK™, Akademy Pharma, 1 capsule/day containing red yeast rice 220 mg (at least 3,3 mg of Monacolin K) + Berberine 531,25 mg + Morus Alba 200 mg (at least 4 mg of Deoxynojirimycin) vs. Armolipid Plus®, Meda Pharma, 1 capsule/day containing Berberis aristata d.e. 588 mg (equivalent to Berberine chloride 500 mg) + Red yeast rice 200 mg (equivalent to Monacolin K 3 mg) + Policosanol 10 mg + Folic acid 0.2 mg + Coenzyme Q10 2.0 mg + Astaxanthin 0.5 mg] on lipid and metabolic profile, platelet aggregation, endothelial function and coronary flow reserve (CFR). For this purpose patients with hypercholesterolemia not requiring statins or statin intolerant at moderate cardiovascular risk will be subjected at day 0 and at day 28, after 4 weeks of therapy, to blood sampling to evaluate lipid and metabolic profile, peripheral arterial tonometry (EndoPAT), platelet aggregation tests with light transmission aggregometry (LTA), nitric oxide (NO) release, endothelial nitric oxide synthase (eNOS) phosphorylation on platelets. Only for CFR, patients will be further evaluated also after two hours from the administration of the first dose of nutraceutical combined pill. Patients will be randomly assigned to receive therapy with LopiGLIK™ or with Armolipid Plus®.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Endothelial Dysfunction Dietary Supplement: LopiGLIK™ therapy Dietary Supplement: Armolipid Plus® therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial to Evaluate the Effects of Two Different Nutraceutical Therapies on Endothelial Function, Platelet Aggregation, and Coronary Flow Reserve in Hypercholesterolemic Patients at Moderate Cardiovascular Risk
Study Start Date : November 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LopiGLIK™ group
4 weeks of LopiGLIK™ therapy 1 capsule/day
Dietary Supplement: LopiGLIK™ therapy
4 weeks of LopiGLIK™ therapy 1 capsule/day

Active Comparator: Armolipid Plus group
4 weeks of Armolipid Plus therapy 1 capsule/day
Dietary Supplement: Armolipid Plus® therapy
4 weeks of Armolipid Plus® therapy 1 capsule/day




Primary Outcome Measures :
  1. Effects on endothelial function as evaluated by Reactive Hyperemia Index (RHI) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Evaluation of treatment tolerability [ Time Frame: 28 days ]
    Self reporting questionnaire

  2. Reasons for treatment discontinuation [ Time Frame: 28 days ]
    Self reporting questionnaire

  3. Effects on lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) [ Time Frame: 28 days ]
    mg/dL

  4. Effects on metabolic indexes (glucose levels) [ Time Frame: 28 days ]
    mg/dL

  5. Effects on metabolic indexes [insulin plasma levels and insulin sensitivity index (HOMA index)] [ Time Frame: 28 days ]
    microIU/mL

  6. Effects on platelet aggregation as evaluated by light transmission aggregometry (LTA) [ Time Frame: 28 days ]
  7. Effects on coronary flow reserve (CFR) as evaluated by echocardiocolorDoppler visualization of coronary flow in the distal left anterior descending artery at rest and after cold pressure test (CPT) [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-70 years old
  2. Patients with hypercholesterolemia and moderate cardiovascular risk according to current ESC guidelines (risk of fatal cardiovascular event of 1-9% at 10 years according to SCORE risk charts of low-risk populations)
  3. Patients giving written Informed Consent.

Exclusion Criteria:

  1. Statin treatment indication
  2. Previous cardiovascular event
  3. Diabetes mellitus
  4. Creatinine Clearance <60ml/min/1.73mm2
  5. Moderate to severe anemia Hb < 10mg/dl
  6. Platelet count >600 x 103/mm3 o <150 x 103/mm3 o hematocrit (HCT) >50% o <25%

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): NCT02969070


Contacts
Contact: Giuseppe Giugliano, MD, PhD +390817462240 giuseppe.giugliano@unina.it

Locations
Italy
University of Naples "Federico II" Recruiting
Naples, Italy, 80131
Contact: Giuseppe Giugliano, MD, PhD    +390817462240    giuseppe.giugliano@unina.it   
Sub-Investigator: Raffaele Izzo, MD         
Sub-Investigator: Maurizio Galderisi, MD         
Sub-Investigator: Giuseppe Giugliano, MD, PhD         
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Bruno Trimarco, MD Federico II University

Publications:
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23.

Responsible Party: Bruno Trimarco, Professor, Federico II University
ClinicalTrials.gov Identifier: NCT02969070     History of Changes
Other Study ID Numbers: FedericoIIU 259/16
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases