NCT05589636

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

October 18, 2022

Last Update Submit

October 18, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Low-density lipoprotein (LDL) cholesterol

    Changes in LDL cholesterol at 12 weeks in both study arms

    12 weeks

Secondary Outcomes (10)

  • body mass index (BMI)

    12 weeks

  • waist circumference

    12 weeks

  • fasting plasma glucose (FPG)

    12 weeks

  • insulinemia

    12 weeks

  • glycated hemoglobin

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Bergamot juice

EXPERIMENTAL

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

Dietary Supplement: Bergamot Juice

Free diet

NO INTERVENTION

Free diet

Interventions

Bergamot JuiceDIETARY_SUPPLEMENT

Bergamot Juice (35% in water)

Bergamot juice

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Parma, Department of Medicine and Surgery

Parma, 43126, Italy

RECRUITING

Related 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.

    PMID: 32441543BACKGROUND

  • 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. doi: 10.2174/1389557515666150709110222.

    PMID: 26156545BACKGROUND

  • 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.

    PMID: 19572741BACKGROUND

  • Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu 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.

    PMID: 28444290BACKGROUND

  • 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.

    PMID: 27673306BACKGROUND

Central Study Contacts

Alessandra Dei Cas, Prof.

CONTACT

+390521033321alessandra.deicas@unipr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 21, 2022

Study Start

February 10, 2022

Primary Completion

December 1, 2022

Study Completion

July 1, 2023

Last Updated

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)