Trials / Completed
CompletedNCT02205567
Bergamot and Cardio-Metabolic Risk Factors
The Effect of Bergamot on Plasma Lipids, Lipoproteins and Carotid Intima-media Thickness
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (actual)
- Sponsor
- University of Palermo · Academic / Other
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Bergamot-derived products have shown significant effects on plasma lipids. We aim in the present study to evaluate the effect of bergamot on several cardio-metabolic risk markers.
Detailed description
The research hypothesis is to assess whether bergamot reduces plasma lipids (total cholesterol, triglycerides, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol), atherogenic lipoproteins, carotid intima-media thickness (IMT) and liver steatosis in patients with dyslipidemia. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Bergamot-derived product | Group 1: 500mg/day Group 2: 1000mg/day |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-06-01
- Completion
- 2015-08-01
- First posted
- 2014-07-31
- Last updated
- 2015-08-06
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02205567. Inclusion in this directory is not an endorsement.