Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02205567
Brief 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.
Study:
NCT02205567
Study Brief:
Protocol Section:
NCT02205567