ISRCTN - ISRCTN72996101: Prenylflavanoids as a biomarker of beer consumption

Plain English Summary

Background and study aims
Prenylflavanoids (a group of plant hormones) are mainly found in hops, and therefore, in beer. Thus, the intake of beer might be assessed through its quantity present in the urine. The aim of this study is to assess the usefulness of urinary prenylflavanoids as a biomarker of beer consumption.

Who can participate?
Healthy adults, in the age range 18-35 years, non-smokers, without previous history of heart, liver or kidney disease, disorders with body balance, any other long-lasting diseases, high blood pressure or Dyslipidemia (abnormal cholesterol/fat level in the blood), alcoholism or other toxic abuse.

What does the study involve?
The volunteers were given different doses of beer at dinner in a random order. Male volunteers consumed 330, 660 and 990 ml of beer, and female volunteers consumed 330, 495 and 660 ml of beer. Before each dose, volunteers followed a 4-day wash-out period in which they were requested to avoid consuming any type of hop-based products and beer. Urine sample was collected before each dose.

What are the possible benefits and risks of participating?
There are no risks as long as the exclusion criteria are followed. 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 (Barcelona, Spain) and the Department of Internal Medicine, Hospital Clinic, Institut dInvestigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona (Barcelona,Spain).

When is the study starting and how long is it expected to run for?
This study was conducted between March 2011 and October 2011.

Who is funding the study?
This study was supported by the European Foundation for Alcohol Research (ERAB) (Belgium).

Who is the main contact?
Dr. Rosa Lamuela-Raventós, Nutrition and Food Science Department, School of Pharmacy, University of Barcelona, Av. Joan XXIII, s/n 08028 Barcelona, Spain.
E-mail: lamuela@ub.edu
Fax+34-934035931; Tel: +34-934034843

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rosa Maria Lamuela Raventos

ORCID ID

Contact details

Av. Joan XXII s/n
Edific B. Deaprtament de Nutricio i Broamtologia
Facultat de Farmcia
Universitat de
Barcelona
Barcelona
08028
Spain
lamuela@ub.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Urinary isoxanthohumol excretion as a biomarker of beer consumption

Acronym

Study hypothesis

Hops and beer are a unique source of xanthohumol, isoxanthohumol and 8-prenylnringenin. Therefore, prenylflavanoids, such as isoxanthohumol and their metabolites may be a potent biomarker of beer consumption, thus the intake of beer can be assessed by quantifying isoxanthohumol in urine.

Ethics approval

Ethics Committee of University of Barcelona (Institutional Review Board IRB00003099), 04/07/2011

Study design

Dose-response randomised cross-over clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

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

Condition

Beer consumption

Intervention

Male volunteers:
Intervention 1: Administration of 330 mL beer (14.5 g ethanol)
Intervention 2: Administration of 660 mL beer (29 g ethanol)
Intervention 3: Administration of 990 mL beer (43.5 g ethanol)

Female volunteers:
Intervention 1: Administration of 330 mL beer (14.5 g ethanol)
Intervention 2: Administration of 495 mL beer (21.7 g ethanol)
Intervention 3: Administration of 660 mL beer (29 g ethanol)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Concentrations of urinary prenylflavanoids will be determined by liquid chromatography coupled to tandem mass spectrometry (LCMS/MS). These determinations will be carried out in first morning urine samples collected the day before the first intervention and in the subsequent mornings following each intervention. Creatinine adjustment will be used to normalize analyte concentrations in these urine samples.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

31/03/2011

Overall trial end date

28/10/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Young healthy volunteers of age 28±3 years, body mass index 22.69±2.69 kg/m2

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

41 (20 men and 21 women)

Participant exclusion criteria

1. Previous history of cardiovascular disease (ischemic heart disease criteria - angina, 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

31/03/2011

Recruitment end date

28/10/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Av. Joan XXII s/n
Barcelona
08028
Spain

Sponsor information

Organisation

Center for Biomedical Research in Pathophysiology of Obesity & Nutrition (Ciber Fisiopatología de la Obesidad Nutrición)(Spain)

Sponsor type

Research organisation

Website

Funders

Funder type