Effect of Mediterranean diet components on microbiota
| ISRCTN | ISRCTN20979777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20979777 |
- Submission date
- 03/11/2020
- Registration date
- 16/12/2020
- Last edited
- 13/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
The microbiome consists of all the microbes (bacteria, fungi, protozoa and viruses) that live on and inside the human body. Diet plays a fundamental role in the composition of the gut microbiome. The Mediterranean diet (MD) is considered a healthy diet and is associated with the prevention of numerous diseases. Such beneficial effects might be due to components such as fiber, unsaturated fatty acids and antioxidants (i.e. polyphenols). Although there is increasing evidence of the beneficial effects of several nutrients on the gut microbiome, the effect on the microbiome of a diet such as the MD has not been sufficiently studied. The aim of this study is to measure how the components of the MD affect the gut microbiome in overweight people with habitually low adherence to the MD.
Who can participate?
Men and women aged 30-60 who are overweight with low adherence to the Mediterranean diet
What does the study involve?
Participants will be randomly allocated to consume one of two products (75 g of an MD-enriched product or a placebo product) daily for 8 weeks. At the beginning and at the end of the intervention, blood, urine, and stool samples will be collected.
What are the possible benefits and risks of participating?
The MD-enriched product may have beneficial effects on the gut by increasing the levels of bacteria associated with health. There are no notable risks involved with participating.
Where is the study run from?
1. Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milano (Italy)
2. Department of Agricultural, Forest and Food Sciences (DISAFA), University of Torino (Italy)
3. Department of Soil, Plant, and Food Sciences (DiISSPA), University of Bari - Aldo Moro (Italy)
4. Department of Biomedical Sciences and Human Oncology (DIMO), University of Bari - Aldo Moro (Italy)
When is the study starting and how long is it expected to run for?
February 2020 to September 2023
Who is funding the study?
Ministry of Education, Universities and Research (Italy)
Who is the main contact?
1. Prof. Marco Gobbetti (marco.gobbetti@unibz.it)
2. Dr. Cristian Del Bo' (cristian.delbo@unimi.it)
3. Prof. Luca Cocolin (lucasimone.cocolin@unito.it)
4. Prof. Simona Bo (simona.bo@unito.it)
5. Dott. Ilario Ferrocino (ilario.ferrocino@unito.it)
6. Prof. Maria De Angelis (maria.deangelis@uniba.it)
7. Prof. Piero Portincasa (piero.portincasa@uniba.it)
8. Prof. Patrizia Brigidi (patrizia.brigidi@unibo.it)
9. Prof. Danilo Ercolini (ercolini@unina.it)
Contact information
Scientific
Via G. Celoria 2
Milano
20133
Italy
 ORCID ID |
0000-0001-7562-377X |
|---|---|
| Phone | +39 (0)250316730 |
| cristian.delbo@unimi.it |
Scientific
Largo Paolo Braccini 2
Grugliasco (TO)
10095
Italy
| ORCID ID |
0000-0003-4799-7074 |
|---|---|
| Phone | +39 (0)116708553 |
| lucasimone.cocolin@unito.it |
Scientific
Corso Dogliotti 14
Torino
10126
Italy
| ORCID ID |
0000-0001-6862-8628 |
|---|---|
| Phone | +39 (0)116335543 |
| simona.bo@unito.it |
Scientific
Largo Paolo Braccini 2
Torino
10095 Grugliasco (TO)
Italy
| ORCID ID |
0000-0002-1657-0054 |
|---|---|
| Phone | +39 (0)116708847 |
| ilario.ferrocino@unito.it |
Scientific
via G. Amendola 165/A
Bari
70126
Italy
| ORCID ID |
0000-0002-2010-884X |
|---|---|
| Phone | +39 (0)805442949 |
| maria.deangelis@uniba.it |
Scientific
Piazza Giulio Cesare n.11
Bari
70121
Italy
| ORCID ID |
0000-0001-5359-1471 |
|---|---|
| Phone | +39 (0)805478227 |
| piero.portincasa@uniba.it |
Scientific
Via G. Celoria 2
Milano
20133
Italy
| ORCID ID |
0000-0003-4134-0557 |
|---|---|
| Phone | +39 (0)250316063 |
| alberto.battezzati@unimi.it |
Public
Via G. Celoria 2
Milano
20133
Italy
| Phone | +39 (0)50316730 |
|---|---|
| cristian.delbo@unimi.it |
Public
Piazza Università, 5
Bozen
39100
Italy
| Phone | +39 (0)471 017215 |
|---|---|
| marco.gobbetti@unibz.it |
Study information
| Study design | Two-arm randomized double-blind placebo-controlled multicenter parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Microbiome-tailored food products based on typical Mediterranean diet components |
| Study acronym | MeDGUT |
| Study hypothesis | The present study aims to explore the causal effect of Mediterranean Diet (MD) components (e.g., dietary fiber, polyphenols, glucosinolates) on the structure and function of the gut microbiome (including bacteria, fungi and viruses) and metabolome in overweight individuals with habitually low adherence to MD. |
| Ethics approval(s) | 1. Approved 18/06/2020, Ethics Committee of the University of Milan (Università degli Studi di Milano, via Festa del Perdono 7, 20122, Milano, Italy; +39 (0)2 503 12667; comitato.etico@unimi.it), ref: 67/20 2. Approved 10/06/2020; Ethics Committee of Azienda Ospedaliera Universitaria “Consorziale Policlinico”; Piazza Giulio Cesare 11, Bari, Italy; +39 (0)80 5593399; comitatoetico@policlinico.ba.it), ref: 6408 3. Approved 08/05/2020; Ethics Committee of Bioetica, University of Torino (Comitato di Bioetica d'Ateneo, Direzione Ricerca e Terza Missione, Via Bogino 9, 10123 Torino, Italy; +39 (0)11 6704394; sfaff.cba@unito.it), ref. 179485 |
| Condition | Overweight and low adherence to the Mediterranean Diet |
| Intervention | The following multicentric study involves 120 volunteers (40 subjects for each research centre). Volunteers will be enrolled and randomized based on a computer randomization plan: 1. MD-enriched food product (75 g, walnuts, broccoli, pomegranate and moringa) 2. Placebo (75 g, water, maltodextrin, 0.1% starch and guar gum) Volunteers will consume one portion (75 g) per day of MD-enriched food product or placebo. Each treatment will be 8 weeks long. At the beginning (time zero) and at the end of the intervention (8 weeks), participants will provide blood, urine and stool samples. |
| Intervention type | Supplement |
| Primary outcome measure | Fecal Prevotella relative amount analysed by high-throughput rRNA gene-targeted amplicon sequencing and short-chain fatty acids (SCFAs), urinary and fecal ferulic acid analysed by GC-MS and 1H-NMR at time zero and after 8 weeks |
| Secondary outcome measures | 1. Gut microbiota quantified by a metagenomic approach based on amplicon sequencing ar time zero and after 8 weeks 2. Host-microbe interactions: fecal samples will be treated to safely separate the microbial cells, which will be allowed interact with HT29 cells and the inflammatory activity will be assessed by RT-PCR and ELISA at time zero and after 8 weeks 3. Identification and estimation of gut metabolome in fecal samples by GC-MS and 1H-NMR at time zero and after 8 weeks 4. Shotgun meta-genomics will be carried out on all the fecal samples collected. Meta-proteomics analyses will be performed in a subset of fecal samples. Fecal microorganisms will be recovered and lysed with the aim to identify peptides. The analysis will be performed by gel-free proteomic platforms at time zero and after 8 weeks 5. Inflammatory markers, e.g., C-reactive protein (PCR), interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-α), analysed by ELISA kit at time zero and after 8 weeks 6. Oxidative stress markers (e.g. endogenous and oxidatively induced DNA damage) analysed in blood by comet assay at time zero and after 8 weeks 7. Metabolic and functional markers (e.g., glycemia, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, liver and renal function) assessed by a standardized validated protocol using an automatic biochemical analyser at time zero and time 8 weeks 8. Anthropometric measurements assessed by following international guidelines at time zero and time 8 weeks 9. Blood pressure measured by determining both systolic and diastolic pressure obtained in a resting, seated position following validated guidelines at time zero and 8 weeks 10. Food intake estimated using food diaries and analysed by using specific software at time zero and every 2 weeks until 8 weeks |
| Overall study start date | 02/02/2020 |
| Overall study end date | 30/09/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 125 |
| Participant inclusion criteria | 1. Age 30 - 60 years old 2. BMI 25 - 29.9 kg/m² 3. Low adherence (score ≤ 5) to the Mediterranean diet |
| Participant exclusion criteria | 1. Obesity (BMI <25 or >30 kg/m²) 2. Diabetes, dysthyroidism 3. Chronic constipation, diarrhea or any other gut disease 4. Liver, kidney or other diseases 5. Known food allergies 6. Regular use of medications, dietary supplement 7. Consumption of antibiotics in the previous 3 months 8. Specific diet such as vegan or macrobiotic 9. Pregnancy/lactation 10. SARS-CoV-2 infection diagnosed by molecular diagnostic |
| Recruitment start date | 07/01/2021 |
| Recruitment end date | 25/05/2021 |
Locations
Countries of recruitment
- Italy
Study participating centres
Via G. Celoria 2
Milano
20133
Italy
Department of Medical Sciences
Largo Paolo Braccini 2
Corso Dogliotti 14
Torino
10095/10126
Italy
Department of Biomedical Sciences and Human Oncology
via G. Amendola 165/A / Piazza Giulio Cesare 11
Bari
70126/70121
Italy
Piazza Università, 5
Bozen
39100
Italy
Division of Microbiology
Via Università 100
Portici (NA)
80055
Italy
Unit of Microbial Ecology of Health
Via Massarenti 9
Bologna
40138
Italy
Sponsor information
Government
Viale Trastevere, 76/a
Roma
00153
Italy
| Phone | +39 (0)658494500 |
|---|---|
| urp@istruzione.it | |
| Website | http://www.miur.gov.it/ |
"ROR" |
https://ror.org/0166hxq48 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Education, University and Research, Ministry of Education, Universities and Research, Italian Ministry for Universities and Research, Italian Ministry for Education, University and Research, Italian Ministry of Education, MIUR
- Location
- Italy
Results and Publications
| Intention to publish date | 30/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of study results in high-impact peer-reviewed journals following trial completion. A protocol will be uploaded in the next few months. |
| IPD sharing plan | Data of the markers analysed will be available upon request at the end of the study from: 1. Prof. Marco Gobbetti (marco.gobbetti@unibz.it) 2. Dr. Cristian Del Bo' (cristian.delbo@unimi.it) 3. Prof. Luca Cocolin (lucasimone.cocolin@unito.it) 4. Prof. Simona Bo (simona.bo@unito.it) 5. Dott. Ilario Ferrocino (ilario.ferrocino@unito.it) 6. Prof. Maria De Angelis (maria.deangelis@uniba.it) 7. Prof. Piero Portincasa (piero.portincasa@uniba.it) 8. Prof. Patrizia Brigidi (patrizia.brigidi@unibo.it) 9. Prof. Danilo Ercolini (ercolini@unina.it) Data are anonymous and consent was obtained from participants. |
Editorial Notes
13/03/2023: The following changes have been made:
1. The final enrolment number has been changed from 125 to 123.
2. The overall trial end date has been changed from 30/11/2021 to 30/09/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/08/2022 to 30/08/2024.
18/11/2021: The intention to publish date was changed from 02/06/2022 to 30/08/2022.
30/07/2021: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 31/07/2021 to 25/05/2021.
17/05/2021: The recruitment start date was changed from 21/10/2020 to 07/01/2021.
14/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2021 to 31/07/2021.
2. The overall trial end date has been changed from 30/09/2021 to 30/11/2021.
3. The intention to publish date has been changed from 31/12/2021 to 02/06/2022.
04/01/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2021 to 31/05/2021.
2. The overall end date was changed from 15/04/2021 to 30/09/2021.
3. The plain English summary was updated to reflect these changes.
11/11/2020: Trial's existence confirmed by the Ethics Committee of the University of Milan.
