Effect of Bergamot Juice on LDL Cholesterol Level in Healthy Subjects

Study Overview
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Brief Summary
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A single-centre, randomized (1:1), open label, controlled study to assess the lipid-lowering effect at 12 weeks of 400 cc/die bergamot juice consumption compared to free diet in healthy subjects

Detailed Description
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Cardiovascular diseases (CV) are the first cause of morbidity and mortality in industrialized countries. Hypercholesterolemia is the main CV risk factor: high cholesterol values are directly and linearly correlated with CV events and mortality in the absence of a threshold value. Intervention studies show unequivocally how the decrease in cholesterol levels significantly reduces CV risk. Bergamot juice is considered a possible food with nutraceutical activity, especially as regards the control of blood cholesterol levels. It is now known that bergamot juice has chemical components that can positively affect blood cholesterol levels. These compounds are called 3-hydroxy-3-methyl flavonoids (HMG-flavonoids) and are peculiar to some citrus plants and in particular to the Citrus bergamia species. The aim of this study is to provide clinical evidence of the effect of these metabolites on cholesterol levels. Specifically, a single-centre, randomized (1:1), open label, controlled study is conducted in healthy subjects to evaluate the possible lipid-lowering effects at 12 weeks of 400 cc/die of bergamot juice consumption compared to a free diet. Changes in the following parameters: body mass index (BMI kg/m²), waist circumference, glycemia, insulin, glycated hemoglobin (HbA1C), total cholesterol, HDL cholesterol and triglycerides, plasma levels of inflammatory cytokines, C-reactive protein (hsCRP) and Proprotein convertase subtilisin / kexin type 9 (PCSK9) are also investigated at 12 weeks.

Official Title
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A Randomized Controlled Intervention Study to Assess the Effect of Bergamot Juice on LDL Cholesterol Level in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Bergamot Juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian persons of both sexes aged ≥18 and ≤75 years ability to understand the methods, purposes and implications of the study, and to give free and informed consent Exclusion Criteria: Diabetes mellitus defined according to ADA criteria Present or past history of alcohol or drug abuse or organ failure (kidney and liver) Tumor pathologies in the last 5 years; Past or present cerebro-vascular diseases; Subjects taking drugs or supplements active on the lipid profile; Pregnancy or breastfeeding Presence of severe or monogenic dyslipidemia Use of antibiotics in the last three months before enrollment Subjects who are on a diet for any reason Individuals who have intentionally or unintentionally lost 3 kg or more of body weight in the past 3 months. Known allergies to some components of the product Subjects who do not like bergamot

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bergamot juice<br>Consumption of 400 cc/die of Bergamot juice (35% in water sweetened with stevia) for 12 weeks | Dietary Supplement: Bergamot Juice<br>* Bergamot Juice (35% in water)<br>|
| No Intervention: Free diet<br>Free diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-density lipoprotein (LDL) cholesterol | Changes in LDL cholesterol at 12 weeks in both study arms | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index (BMI) | Changes in body mass index (BMI) at 12 weeks in both study arms | 12 weeks | 
| waist circumference | Changes in waist circumference at 12 weeks in both study arms | 12 weeks | 
| fasting plasma glucose (FPG) | Changes in FPG at 12 weeks in both study arms | 12 weeks | 
| insulinemia | Changes in insulinemia at 12 weeks in both study arms | 12 weeks | 
| glycated hemoglobin | Changes in glycated hemoglobin at 12 weeks in both study arms | 12 weeks | 
| total cholesterol | Changes in total cholesterol at 12 weeks in both study arms | 12 weeks | 
| high density lipoprotein (HDL) cholesterol | Changes in HDL cholesterol at 12 weeks in both study arms | 12 weeks | 
| triglycerides | Changes in triglycerides at 12 weeks in both study arms | 12 weeks | 
| plasma levels of inflammatory cytokines | Changes in plasma levels of inflammatory cytokines (IL-1,IL-6,IL-10,hsPCR,TNF-alpha) at 12 weeks in both study arms | 12 weeks | 
| Proprotein convertase subtilisin/kexin type 9 (PCSK9) | Changes in PCSK9 at 12 weeks in both study arms | 12 weeks |