Effect of Bergamot Juice on LDL Cholesterol Level in Healthy Subjects

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Dietary Supplement: Bergamot Juice

• Registration Number: NCT05589636
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-02-10
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-18
• Study First Posted: 2022-10-21
• Last Update Posted: 2022-10-21
• Primary Completion: 2022-12
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bergamot juice	Bergamot Juice	Consumption of 400 cc/die of Bergamot juice (35% in water sweetened with stevia) for 12 weeks

Primary Outcome Measures

Name	Time	Method
Low-density lipoprotein (LDL) cholesterol	12 weeks	Changes in LDL cholesterol at 12 weeks in both study arms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Parma, Department of Medicine and Surgery; 🇮🇹 Parma, Italy