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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02898805 |
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Date of registration:
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08/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of LopiGLIK® on Cardiovascular Risk
LopiWEB |
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Scientific title:
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Effects of a New Combination of Nutraceutics (LopiGLIK®) on Cardiovascular Risk |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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600 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02898805 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Bruno Trimarco, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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FEDERICO II UNIVERSITY - NAPLES |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Total Cholesterol<300 mg/dL
- Total Cholesterol>200 mg/dL
- Cardiovascular Risk<20%
Exclusion Criteria:
- Pregnancy
- Documented intolerance to one or more 'components LOPIGLIK / Armolipid PLUS
- Previous cardiovascular events
- Familiar severe dyslipidemia
- Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving
lipid-lowering drugs
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cardiovascular Risk Factors
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Intervention(s)
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Other: Placebo
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Dietary Supplement: Armolipid Plus
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Dietary Supplement: LopiGLIK®
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Other: Prescribed Diet
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Primary Outcome(s)
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Reduction of LDL-Cholesterol levels
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Increasing of HDL-Cholesterol levels
[Time Frame: 16 weeks]
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Reduction of HbA1c levels
[Time Frame: 16 weeks]
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Reduction of fastin insuline levels
[Time Frame: 16 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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