Urinary tartaric acid as a sensitive dietary biomarker of moderate wine consumption

ISRCTN ISRCTN63399546
DOI https://doi.org/10.1186/ISRCTN63399546
Secondary identifying numbers N/A
Submission date
22/04/2013
Registration date
09/05/2013
Last edited
03/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Tartaric acid is one of the most abundant acids in red and white wines. Intake of wine might be assessed through urinary concentration. The aim of this study is to assess the usefulness of urinary tartaric acid as a biomarker of wine consumption.

Who can participate?
Healthy adults (males), in the age range 18-50 years, non-smokers, without previous history of
cardiovascular disease, hepatic or renal disease, homeostatic disorders, any several chronic diseases,
hypertension or dislipemia, alcoholism or other toxic abuse.

What does the study involve?
The interventions consisted of intake at dinner, in a random order, of 100, 200 and 300 ml of red wine, corresponding to 10.3, 20.5 and 30.8 g of ethanol, respectively. Before each wine consumption participants followed a 7-day wash-out period during which they were requested to avoid consuming grape-based products. First morning urines were collected the day before the first intervention and in the morning following each intervention.

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 d’Investigació
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?
Between July 2012 and July 2013.

Who is funding the study?
This study is supported by a research grant from ‘Junta de Andalucía’ (Spain).

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

Contact information

Dr Rosa Lamuela Raventós
Scientific

Food Science Department
Pharmacy Faculty
University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain

Email lamuela@ub.edu

Study information

Study designOpen randomized cross-over controlled clinical trial with three feeding interventions
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleUse of urinary concentration of tartaric acid as a dietary biomarker of red and white wine: an open randomized cross-over controlled trial
Study objectivesTartaric acid is one of the most abundant acids in red and white wines. In nature, it is mainly specific to grapes, and therefore, also to wine. Thus, intake of wine might be assessed through its urinary concentration.
Ethics approval(s)Ethics Committee of Clinical Investigation of the University of Barcelona (Spain), 05/02/2013, ref: IRB0003099
Health condition(s) or problem(s) studiedConcentration of tartaric acid in urine
InterventionIntervention 1: Administration of 100 ml red wine (10.3 g ethanol).
Intervention 2: Administration of 200 ml red wine (20.5 g ethanol).
Intervention 3: Administration of 300 ml red wine (30.8 g ethanol).
Before each intervention, participants followed a 7-day washout period, avoiding consuming grape products.

Each subject consumed three doses of red wine (100, 200 and 300 ml) in a random order at three different times, separated by 7-day wash-out periods. Each intervention consisted of a single dose of one of these volumes (100, 200 or 300 ml) and the total duration of the study was 22 days (i.e. 7-day wash-out >first intervention on day 7 >7-day wash-out >second intervention on day 14 >7-day wash-out >third intervention on day 21>end of study).
Intervention typeOther
Primary outcome measureConcentrations of urinary tartaric acid will be determined by liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS). These determinations will be carried out in first morning urines collected the day before the first intervention and in the morning following each intervention. Creatinine adjustment was used to normalize analyze concentrations in these urine samples.

Urinary concentration of tartaric acid was measured at day 7 (before first intervention), at day 8 (10 hours after first intervention), at day 14 (before second intervention), at day 15 (10 hours after second intervention), at day 21 (before third intervention) and at day 22 (10 hours after third intervention).
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/07/2012
Completion date01/07/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexMale
Target number of participants21
Key inclusion criteriaHealthy adults, males, 18-50 years
Key exclusion criteria1. 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 dislipemia
5. Smoking subjects
6. Alcoholism
7. Other toxic abuse
Date of first enrolment01/07/2012
Date of final enrolment01/07/2013

Locations

Countries of recruitment

  • Spain

Study participating centre

Food Science Department
Barcelona
08028
Spain

Sponsor information

CIBER Pathophysiology of Obesity and Nutrition [Ciber Fisiopatología de la Obesidad y Nutrición] (CIBERobn) (Spain)
University/education

Centro Hospitalario Universitario Santiago de Compostela
Edificio d Primera planta
Choupana s/n
Santiago de Compostela
15706
Spain

Email gerencia@ciberobn.es
Website http://www.ciberobn.es
ROR logo "ROR" https://ror.org/00dwgct76

Funders

Funder type

Government

Junta of Andalusia (Junta de Andalucía) (Spain) - Research Grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2014 Yes No