Effect of moderate wine consumption on the clinical symptoms of patients with inflammatory bowel disease
| ISRCTN | ISRCTN11169656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11169656 |
| Secondary identifying numbers | AGL2015-64522-C2-1-R |
- Submission date
- 06/06/2021
- Registration date
- 07/09/2021
- Last edited
- 14/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Previous studies have shown that moderate wine consumption has a beneficial effect on the intestinal function of healthy people. Those benefits include modulation of colonic microbiota (gut microbes) and improved inflammation markers. Many of these benefits are attributed to wine polyphenols, which are found in large quantities in grapes and, therefore, in wine. With this background, the aim of this study is to assess the effect of moderate wine consumption in patients with inflammatory bowel disease, a group of disorders in which the intestines become inflamed, including ulcerative colitis.
Who can participate?
Patients with ulcerative colitis who have not taken antibiotics in the last 6 months or follow restrictive diets
What does the study involve?
Participants are randomly allocated to the intervention group or the control group. Participants begin with a two-week period in which they consume a diet low in polyphenols, after which the intervention group drink 250 ml of wine per day for 4 weeks. The control group participants continue with the low polyphenol diet. Markers of ulcerative colitis are measured using blood tests at the start and the end of the study.
What are the possible benefits and risks of participating?
The expected results are a reduction in markers of ulcerative colitis such as fecal calprotectin and beneficial changes in the intestinal microbiota in patients in the intervention group, as well as an improvement in quality of life and symptoms of the disease.
Where is the study run from?
Institute of Food Science Research (Spain)
When is the study starting and how long is extended to run for?
September 2017 to December 2019
Who is funding the study?
Spanish Ministry of Science and Innovation (Spain)
Who is the main contact?
1. Dr M. Victoria Moreno-Arribas, victoria.moreno@csic.es
2. Dr Begoña Bartolomé
Contact information
Scientific
Institute of Food Science Research, CIAL (CSIC).
Nicolás Cabrera street, 9
Madrid
28049
Spain
 ORCID ID |
0000-0002-4136-595X |
|---|---|
| Phone | +34 (0)910017900 |
| victoria.moreno@csic.es |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not avaliable in web format, please use contact details to request a participant information sheet |
| Scientific title | Moderate wine consumption and digestive function: intestinal microbiota, metabolic functionality and effect on the clinical symptoms of patients with inflammatory bowel disease |
| Study acronym | VinEII |
| Study objectives | Wine, in particular red wine, is a source of dietary polyphenols which possesses a unique combination of phenolic structures (mainly flavonoids, but also non-flavonoids). Previous studies have shown an effect of moderate wine consumption in the modulation of the intestinal microbiota and specifically in the intestinal inflammatory response of healthy individuals. It is hypothesized that moderate and regular intake of red wine may modulate oral and gut microbiota in inflammatory bowel disease (IBD) patients, maintaining and even decreasing the proportions of different disease-related pathogenic groups, promoting a profile more similar to that observed in healthy conditions |
| Ethics approval(s) | Approved 05/10/2017, Ethics Committee of the 'Hospital Universitario La Paz' (261, Castellana Street, Madrid, 28046, Spain; +34 (0)917277413; ceic.hulp@salud.madrid.org) and rhe Spanish National Research Council Ethics Committee (117, Serrano Street, Madrid, 28006, Spain; +34 (0)915681494; subcomitedebioetica@csic.es), ref: not applicable |
| Health condition(s) or problem(s) studied | Ulcerative colitis |
| Intervention | People were allocated randomly at the hospital to the control or intervention group by lottery until occupying the places of the group. The study consists of two periods: a wash-out period (2 weeks in which the participants will not eat foods rich in polyphenols) and an intervention period (4 weeks in which the volunteers of the intervention group will drink 250 ml/day of red wine and the volunteers of the control group will continue with the same diet as in the wash-out period). On the first day after the washout period and the last day of the intervention period, all of the participants go to the hospital after at least 10 hours of fasting. Then, they deliver a sample of faeces taken as recent to this moment as possible (in a stool collection tube introduced in an anaerobic plastic zip bag) and a sample of 24 h urine (in a sterile bottle). Then, they spit into a 15 ml Falcon sterile tube to obtain at least 3 ml of saliva. Also, they complete a questionnaire on quality of life. A sample of blood is taken by a specialist. |
| Intervention type | Supplement |
| Primary outcome measure | Markers of ulcerative colitis such as fecal calprotectin, iron, ferritin, C-reactive protein and white and blood cells measured by routine blood tests at initial and end treatment point (4 weeks) |
| Secondary outcome measures | 1. Quality of life measured by quality of life questionnaires (IBDQ-32) at initial and end treatment point (4 weeks) 2. Microbial phenolic metabolites in faeces and urine measured by ultra-high-performance liquid chromatography–electrospray ionization–tandem mass spectrometry (UHPLC-ESI-MS/MS) at initial and end treatment point (4 weeks) 3. Short and medium-chain fatty acids in faeces measured by solid-phase microextraction gas chromatography-mass spectrometry (SPME-GC-MS) at initial and end treatment point (4 weeks) 4. Composition, abundance and diversity of the faecal microbiota measured by sequencing the V3-V4 region of ribosomal DNA from fecal samples and metagenomic analysis at initial and end treatment point (4 weeks) |
| Overall study start date | 01/09/2017 |
| Completion date | 20/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | Patients diagnosed with mild or moderate ulcerative colitis |
| Key exclusion criteria | 1. Antibiotic intake up to 6 months before the study 3. Type I diabetes, endocrine and gastrointestinal disorders 4. Addiction to drugs or alcohol 5. Restrictive diets (vegetarians, vegans) |
| Date of first enrolment | 03/05/2018 |
| Date of final enrolment | 27/05/2019 |
Locations
Countries of recruitment
- Spain
Study participating centres
Madrid
28049
Spain
San Sebastián de los Reyes - Madrid
28702
Spain
Sponsor information
Research organisation
Spanish National Research Council (CSIC)
Nicolás Cabrera Street, 9
Madrid
28049
Spain
| Phone | +34 (0)607195887 |
|---|---|
| gerencia.cial@csic.es | |
| Website | http://www.cial.uam-csic.es/en/ |
"ROR" |
https://ror.org/04dgb8y52 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- CienciaGob, Ministerio de Ciencia e Innovación de España, Ministry of Science and Innovation, Spanish Ministry of Science and Innovation, Ministry of Science and Innovation of Spain, Spain, Ministry for Science and Innovation, Ministeri de Ciència i Innovació, MCIN, MICINN
- Location
- Spain
Results and Publications
| Intention to publish date | 20/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of at least two research articles in high-impact peer-reviewed journals. At the moment no protocol is available. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from M. Victoria Moreno-Arribas (victoria.moreno@csic.es). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/05/2022 | 14/06/2022 | Yes | No |
Editorial Notes
14/06/2022: Publication reference added.
08/06/2021: Trial's existence confirmed by the Ethics Committee of the 'Hospital Universitario La Paz'.
