Prenylflavanoids as a biomarker of beer consumption

ISRCTN	ISRCTN72996101
DOI	https://doi.org/10.1186/ISRCTN72996101
Secondary identifying numbers	N/A

Submission date: 24/04/2013
Registration date: 16/05/2013
Last edited: 23/05/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Rosa Maria Lamuela Raventos
Scientific

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

Email	lamuela@ub.edu

Study information

Study design	Dose-response randomised cross-over clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Urinary isoxanthohumol excretion as a biomarker of beer consumption
Study objectives	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(s)	Ethics Committee of University of Barcelona (Institutional Review Board IRB00003099), 04/07/2011
Health condition(s) or problem(s) studied	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
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 study start date	31/03/2011
Completion date	28/10/2011

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	41 (20 men and 21 women)
Key inclusion criteria	Young healthy volunteers of age 28±3 years, body mass index 22.69±2.69 kg/m2
Key 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
Date of first enrolment	31/03/2011
Date of final enrolment	28/10/2011

Locations

Countries of recruitment

Spain

Study participating centre

Av. Joan XXII s/n

Barcelona
08028
Spain

Sponsor information

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

CENTRO HOSPITALARIO UNIVERSITARIO SANTIAGO DE COMPOSTELA
EDIFICIO D 1ª PLANTA
CHOUPANA S/N
CIF: G 84 884 428
SANTIAGO DE COMPOSTELA
15706
Spain

Email	lamuela@ub.edu
"ROR"	https://ror.org/02s65tk16

Funders

Funder type

Research organisation

Center for Biomedical Research in Pathophysiology of Obesity and Nutrition (CIBERobn) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2014		Yes	No