Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2014-06-30
2015-08-31
Brief Summary
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Detailed Description
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The primary objective is to assess whether bergamot reduces plasma lipids and atherogenic lipoproteins in patients with dyslipidemia.
Primary endpoint: Reduction in plasma lipids and atherogenic lipoproteins. The secondary objective is to assess whether bergamot reduces carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia.
Secondary endpoint: Reduction in IMT and and liver steatosis.
Clinical diagnostic tools will include the measurement of:
1. cIMT, that will be assessed by B-mode real-time ultrasound using a single sonographer (Medison SonoAce Pico, with a probe of 7.5-10.0 MHz) in a standardized manner with fixed angles of insonation;
2. liver steatosis, that will be assessed by by abdominal ultrasound.
Biochemical analyses will include the analysis of:
1. Routine testing of plasma lipids;
2. Atherogenic lipoproteins, e.g. the analysis of 11 distinct lipoproteins including very-low-density lipoprotein (VLDL), 3 intermediate density lipoprotein (IDL) subclasses and 7 low density lipoprotein (LDL) subclasses.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group 2
1000 mg/day of Bergamot-derived product
Bergamot-derived product
Group 1: 500mg/day Group 2: 1000mg/day
Group 1
500 mg/day of Bergamot-derived product
Bergamot-derived product
Group 1: 500mg/day Group 2: 1000mg/day
Interventions
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Bergamot-derived product
Group 1: 500mg/day Group 2: 1000mg/day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
35 Years
75 Years
ALL
No
Sponsors
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University of Palermo
OTHER
Responsible Party
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Manfredi Rizzo
Assistant Professor
Principal Investigators
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Giuseppe Montalto, MD
Role: STUDY_DIRECTOR
University of Palermo, Italy
Locations
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University Hospital of Palermo
Palermo, PA, Italy
Countries
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Other Identifiers
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BMT14
Identifier Type: -
Identifier Source: org_study_id
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