A Randomized Controlled Intervention Study to Assess the Effect of Bergamot Juice on LDL Cholesterol Level in Healthy Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Low-density lipoprotein (LDL) cholesterol
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Low-density lipoprotein (LDL) cholesterol
Time Frame: 12 weeks
Changes in LDL cholesterol at 12 weeks in both study arms
Secondary Outcomes
- insulinemia(12 weeks)
- body mass index (BMI)(12 weeks)
- waist circumference(12 weeks)
- glycated hemoglobin(12 weeks)
- total cholesterol(12 weeks)
- high density lipoprotein (HDL) cholesterol(12 weeks)
- Proprotein convertase subtilisin/kexin type 9 (PCSK9)(12 weeks)
- triglycerides(12 weeks)
- fasting plasma glucose (FPG)(12 weeks)
- plasma levels of inflammatory cytokines(12 weeks)
Investigators
Alessandra Dei Cas
Associate Professor
University of Parma