Condition category
Not Applicable
Date applied
07/02/2014
Date assigned
13/05/2014
Last edited
13/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Grapefruit contains high amounts of furanocoumarins, a group of compounds that are known to reduce the activity of intestinal enzymes. As a result, grapefruit juice can interact with a variety of drugs that are taken orally. The aim of this study is to find out whether the breakdown products of furanocoumarin can be used as markers of grapefruit juice consumption.

Who can participate?
Healthy men aged 20-35 years.

What does the study involve?
Participants will be randomly allocated to drink 250 mL of either orange, lemon or grapefruit juice at dinner time. There will then be a 7-day break in which participants are requested to avoid consuming citric-based products. Participants will then repeat this process twice with the second and third juices. Urine samples will be collected the day before the first intervention and in the morning following each intervention.

What are the possible benefits and risks of participating?
The study was conducted according to the Declaration of Helsinki of the World Medical Association. The study was explained to subjects through verbal and written instructions, and written informed consent was obtained before participation.

Where is the study run from?
This study involved the Department of Nutrition and Food Science of the University of Barcelona (Spain).

When is the study starting and how long is it expected to run for?
This study will take place between May 2013 and March 2014.

Who is funding the study?
This study is supported by CIBERobn.

Who is the main contact?
Dr Rosa Lamuela-Raventós
lamuela@ub.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosa Lamuela-Raventós

ORCID ID

Contact details

Nutrition and Food Science Department
School of Pharmacy
University of Barcelona
Av. Joan XXIII
s/n
Barcelona
08028
Spain
+34 (0) 934 034 843
lamuela@ub.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Targeted metabolomics approach for the determination of furanocoumarin metabolites in urine after grapefruit juice consumption

Acronym

Study hypothesis

Grapefruit contains considerable amounts of furanocoumarins, a family of compounds which are known to strongly inhibit intestinal cytochrome P450 (CYP) enzymes, namely CYP3A4. As a result, grapefruit juice can interact with a variety of orally administered drugs by increasing their bioavailability. This study aims to study the potential of furanocoumarin metabolites as specific biomarkers of grapefruit juice consumption.

Ethics approval

Ethics Committee of Clinical Investigation of the University of Barcelona (Spain),18/12/2014, ref: IRB00003099

Study design

Open controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Concentration of furanocoumarin metabolites in urine

Intervention

Participants are randomly assigned following simple randomization procedures (computerized random numbers) to one of three treatment groups. The study is a randomized crossover feeding trial. Participants will cross over and undergo all three of the interventions.

Intervention 1: Administration of 250 mL orange juice.
Intervention 2: Administration of 250 mL lemon juice.
Intervention 3: Administration of 250 mL grapefruit juice

Before each intervention, participants will follow a 7-day washout period, avoiding consuming citric or citric-based products

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Furanocoumarin metabolites will be identified through liquid chromatography coupled to Orbitrap mass spectrometry. Concentrations of furanocoumarins will be determined by liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS). These determinations will be carried out in first morning urine samples collected the day before the first intervention and in the morning following each intervention.

Secondary outcome measures

N/A

Overall trial start date

01/05/2013

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adult males aged 20-35 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

15

Participant exclusion criteria

1. Previous history of cardiovascular disease (ischemic heart disease - angina or recent or old myocardial infarction, cerebral vascular accident, or peripheral vascular disease)
2. Homeostatic disorders
3. Any several chronic diseases
4. Hypertension or dyslipidemia
5. Smoking subjects
6. Alcoholism
7. Other toxic abuse

Recruitment start date

01/05/2013

Recruitment end date

01/04/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Nutrition and Food Science Department
Barcelona
08028
Spain

Sponsor information

Organisation

Centros de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (CIBERobn) (Spain)

Sponsor details

Centro Hospitalario Universitario de Santiago de Compostela
Edificio "D" 1ª
Planata
Choupana
S/N
Santiago de Compostela
15706
Spain
gerencia@ciberobn.es

Sponsor type

Research organisation

Website

http://www.ciberobn.es/

Funders

Funder type

Research organisation

Funder name

Centros de Investigación Biomédica en Red Fisiopatología de la Obesidad y la Nutrición (Centers of Biomedical Research Network Pathophysiology of Obesity and Nutrition) (CIBERobn) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes