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 measures
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
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 details
CENTRO HOSPITALARIO UNIVERSITARIO SANTIAGO DE COMPOSTELA
EDIFICIO D 1ª PLANTA
CHOUPANA S/N
CIF: G 84 884 428
SANTIAGO DE COMPOSTELA
15706
Spain
lamuela@ub.edu
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Center for Biomedical Research in 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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24477299
Publication citations
-
Results
Quifer-Rada P, Martínez-Huélamo M, Chiva-Blanch G, Jáuregui O, Estruch R, Lamuela-Raventós RM, Urinary isoxanthohumol is a specific and accurate biomarker of beer consumption., J. Nutr., 2014, 144, 4, 484-488, doi: 10.3945/jn.113.185199.