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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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17 August 2015 |
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Main ID: |
NCT02205567 |
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Date of registration:
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29/07/2014 |
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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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Bergamot and Cardio-Metabolic Risk Factors
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Scientific title:
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The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02205567 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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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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Giuseppe Montalto, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Palermo, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- elevated LDL-cholesterolemia
Exclusion Criteria:
- severe hepatic or renal diseases
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dyslipidemia
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Intervention(s)
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Dietary Supplement: Bergamot-derived product
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Primary Outcome(s)
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Change from baseline in plasma lipids
[Time Frame: baseline and 6 months]
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Secondary Outcome(s)
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Change from baseline in atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis
[Time Frame: baseline and 6 months]
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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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