Condition category
Not Applicable
Date applied
22/04/2013
Date assigned
09/05/2013
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosa Lamuela Raventós

ORCID ID

Contact details

Food Science Department
Pharmacy Faculty
University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain
lamuela@ub.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Use of urinary concentration of tartaric acid as a dietary biomarker of red and white wine: an open randomized cross-over controlled trial

Acronym

Study hypothesis

Tartaric 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

Ethics Committee of Clinical Investigation of the University of Barcelona (Spain), 05/02/2013, ref: IRB0003099

Study design

Open randomized cross-over controlled clinical trial with three feeding interventions

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Concentration of tartaric acid in urine

Intervention

Intervention 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Concentrations 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 measures

No secondary outcome measures

Overall trial start date

01/07/2012

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults, males, 18-50 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

21

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 dislipemia
5. Smoking subjects
6. Alcoholism
7. Other toxic abuse

Recruitment start date

01/07/2012

Recruitment end date

01/07/2013

Locations

Countries of recruitment

Spain

Trial participating centre

Food Science Department
Barcelona
08028
Spain

Sponsor information

Organisation

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

Sponsor details

Centro Hospitalario Universitario Santiago de Compostela
Edificio d Primera planta
Choupana s/n
Santiago de Compostela
15706
Spain
gerencia@ciberobn.es

Sponsor type

University/education

Website

http://www.ciberobn.es

Funders

Funder type

Government

Funder name

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

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/24507823

Publication citations

  1. Results

    Regueiro J, Vallverdú-Queralt A, Simal-Gándara J, Estruch R, Lamuela-Raventós RM, Urinary tartaric acid as a potential biomarker for the dietary assessment of moderate wine consumption: a randomised controlled trial., Br. J. Nutr., 2014, 111, 9, 1680-1685, doi: 10.1017/S0007114513004108.

Additional files

Editorial Notes