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HealthyNCT05589636

Effect of Bergamot Juice on LDL Cholesterol Level in Healthy Subjects

A study testing Bergamot Juice in people with Healthy, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Bergamot Juice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteItaly
Study dates
10 Feb 2022to Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Alessandra Dei Cas, Prof. contact

+390521033321

alessandra.deicas@unipr.it

Italy1 site, 1 recruiting

  • University of Parma, Department of Medicine and Surgery

    Parma, 43126

    Alessandra Dei Cas, Prof, +39 0521033321, alessandra.deicas@unipr.it

    Raffaella Aldigeri, Dr, +39 0521033306, raffaella.aldigeri@unipr.it

    Recruiting

Other trials in Italy

About this study

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

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

Read the 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.

Conditions
Healthy
Being tested
Bergamot Juice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bergamot JuiceDietary supplement

    Bergamot Juice (35% in water)

Study groups in NCT05589636
Study groupRoleWhat they receive
Bergamot juiceExperimentalConsumption of 400 cc/die of Bergamot juice (35% in water sweetened with stevia) for 12 weeks
Receives: Dietary Supplement: Bergamot Juice
Free dietNo interventionFree diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Low-density lipoprotein (LDL) cholesterol

    Changes in LDL cholesterol at 12 weeks in both study arms

    Measured: 12 weeks

Secondary outcomes (10)

  1. body mass index (BMI)

    Changes in body mass index (BMI) at 12 weeks in both study arms

    Measured: 12 weeks

  2. waist circumference

    Changes in waist circumference at 12 weeks in both study arms

    Measured: 12 weeks

  3. fasting plasma glucose (FPG)

    Changes in FPG at 12 weeks in both study arms

    Measured: 12 weeks

  4. insulinemia

    Changes in insulinemia at 12 weeks in both study arms

    Measured: 12 weeks

  5. glycated hemoglobin

    Changes in glycated hemoglobin at 12 weeks in both study arms

    Measured: 12 weeks

  6. total cholesterol

    Changes in total cholesterol at 12 weeks in both study arms

    Measured: 12 weeks

  7. high density lipoprotein (HDL) cholesterol

    Changes in HDL cholesterol at 12 weeks in both study arms

    Measured: 12 weeks

  8. triglycerides

    Changes in triglycerides at 12 weeks in both study arms

    Measured: 12 weeks

  9. 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

    Measured: 12 weeks

  10. Proprotein convertase subtilisin/kexin type 9 (PCSK9)

    Changes in PCSK9 at 12 weeks in both study arms

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study start10 Feb 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05589636
Sponsor's protocol ID
562/2021/SPER /UNIPR
Status last verified
Oct 2022
First submitted
18 Oct 2022
Last updated
21 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32441543

  • 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.

    PubMed 26156545

  • 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.

    PubMed 19572741

  • 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.

    PubMed 28444290

  • 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.

    PubMed 27673306

Questions about this trial

What is this clinical trial studying?

A study testing Bergamot Juice in people with Healthy, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alessandra Dei Cas, Prof. (+390521033321, alessandra.deicas@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low-density lipoprotein (LDL) cholesterol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05589636, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.

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