Effect of Bergamot Juice on LDL Cholesterol Level in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589636
• Other study ID #: 562/2021/SPER /UNIPR
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: July 2023

Study information

• Verified date: October 2022
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: Alessandra Dei Cas, Prof.
• Phone: +390521033321
• Email: alessandra.deicas[@]unipr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Bergamot Juice
Bergamot Juice (35% in water)

Locations

Country	Name	City	State
Italy	University of Parma, Department of Medicine and Surgery	Parma

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma	University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Ballistreri G, Amenta M, Fabroni S, Consoli V, Grosso S, Vanella L, Sorrenti V, Rapisarda P. Evaluation of lipid and cholesterol-lowering effect of bioflavonoids from bergamot extract. Nat Prod Res. 2021 Dec;35(23):5378-5383. doi: 10.1080/14786419.2020.1768085. Epub 2020 May 22. — View Citation

Cappello AR, Dolce V, Iacopetta D, Martello M, Fiorillo M, Curcio R, Muto L, Dhanyalayam D. Bergamot (Citrus bergamia Risso) Flavonoids and Their Potential Benefits in Human Hyperlipidemia and Atherosclerosis: an Overview. Mini Rev Med Chem. 2016;16(8):619-29. Review. — View Citation

Di Donna L, De Luca G, Mazzotti F, Napoli A, Salerno R, Taverna D, Sindona G. Statin-like principles of bergamot fruit (Citrus bergamia): isolation of 3-hydroxymethylglutaryl flavonoid glycosides. J Nat Prod. 2009 Jul;72(7):1352-4. doi: 10.1021/np900096w. — View Citation

Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Borén J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgözoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144. Review. — View Citation

Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-density lipoprotein (LDL) cholesterol	Changes in LDL cholesterol at 12 weeks in both study arms	12 weeks
Secondary	body mass index (BMI)	Changes in body mass index (BMI) at 12 weeks in both study arms	12 weeks
Secondary	waist circumference	Changes in waist circumference at 12 weeks in both study arms	12 weeks
Secondary	fasting plasma glucose (FPG)	Changes in FPG at 12 weeks in both study arms	12 weeks
Secondary	insulinemia	Changes in insulinemia at 12 weeks in both study arms	12 weeks
Secondary	glycated hemoglobin	Changes in glycated hemoglobin at 12 weeks in both study arms	12 weeks
Secondary	total cholesterol	Changes in total cholesterol at 12 weeks in both study arms	12 weeks
Secondary	high density lipoprotein (HDL) cholesterol	Changes in HDL cholesterol at 12 weeks in both study arms	12 weeks
Secondary	triglycerides	Changes in triglycerides at 12 weeks in both study arms	12 weeks
Secondary	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
Secondary	Proprotein convertase subtilisin/kexin type 9 (PCSK9)	Changes in PCSK9 at 12 weeks in both study arms	12 weeks