Urinary tartaric acid as a sensitive dietary biomarker of moderate wine consumption
ISRCTN | ISRCTN63399546 |
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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
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 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?
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
Scientific
Food Science Department
Pharmacy Faculty
University of Barcelona
Av/ Joan XXIII S/N
Barcelona
08028
Spain
lamuela@ub.edu |
Study information
Study design | Open randomized cross-over controlled clinical trial with three feeding interventions |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Screening |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study objectives | 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(s) | Ethics Committee of Clinical Investigation of the University of Barcelona (Spain), 05/02/2013, ref: IRB0003099 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Concentrations of urinary tartaric acid will be determined by liquid chromatography coupled to tandem mass spectrometry (LCMS/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 study start date | 01/07/2012 |
Completion date | 01/07/2013 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 50 Years |
Sex | Male |
Target number of participants | 21 |
Key inclusion criteria | Healthy adults, males, 18-50 years |
Key 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 |
Date of first enrolment | 01/07/2012 |
Date of final enrolment | 01/07/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
08028
Spain
Sponsor information
University/education
Centro Hospitalario Universitario Santiago de Compostela
Edificio d Primera planta
Choupana s/n
Santiago de Compostela
15706
Spain
gerencia@ciberobn.es | |
Website | http://www.ciberobn.es |
https://ror.org/00dwgct76 |
Funders
Funder type
Government
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/05/2014 | Yes | No |