Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/11/2020
Date assigned
16/12/2020
Last edited
04/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 2021 (updated 04/01/2021, previously: April 2021)

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cristian Del Bo'

ORCID ID

http://orcid.org/0000-0001-7562-377X

Contact details

Via G. Celoria 2
Milano
20133
Italy
+39 (0)250316730
cristian.delbo@unimi.it

Type

Scientific

Additional contact

Prof Luca Cocolin

ORCID ID

https://orcid.org/0000-0003-4799-7074

Contact details

Largo Paolo Braccini 2
Grugliasco (TO)
10095
Italy
+39 (0)116708553
lucasimone.cocolin@unito.it

Type

Scientific

Additional contact

Prof Simona Bo

ORCID ID

https://orcid.org/0000-0001-6862-8628

Contact details

Corso Dogliotti 14
Torino
10126
Italy
+39 (0)116335543
simona.bo@unito.it

Type

Scientific

Additional contact

Dr Ilario Ferrocino

ORCID ID

https://orcid.org/0000-0002-1657-0054

Contact details

Largo Paolo Braccini 2
Torino
10095 Grugliasco (TO)
Italy
+39 (0)116708847
ilario.ferrocino@unito.it

Type

Scientific

Additional contact

Prof Maria De Angelis

ORCID ID

http://orcid.org/0000-0002-2010-884X

Contact details

via G. Amendola 165/A
Bari
70126
Italy
+39 (0)805442949
maria.deangelis@uniba.it

Type

Scientific

Additional contact

Prof Piero Portincasa

ORCID ID

http://orcid.org/0000-0001-5359-1471

Contact details

Piazza Giulio Cesare n.11
Bari
70121
Italy
+39 (0)805478227
piero.portincasa@uniba.it

Type

Scientific

Additional contact

Prof Alberto Battezzati

ORCID ID

http://orcid.org/0000-0003-4134-0557

Contact details

Via G. Celoria 2
Milano
20133
Italy
+39 (0)250316063
alberto.battezzati@unimi.it

Type

Public

Additional contact

Dr Cristian Del Bo'

ORCID ID

Contact details

Via G. Celoria 2
Milano
20133
Italy
+39 (0)50316730
cristian.delbo@unimi.it

Type

Public

Additional contact

Prof Marco Gobbetti

ORCID ID

Contact details

Piazza Università
5
Bozen
39100
Italy
+39 (0)471 017215
marco.gobbetti@unibz.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Microbiome-tailored food products based on typical Mediterranean diet components

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

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

Study design

Two-arm randomized double-blind placebo-controlled multicenter parallel study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

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

Phase

Drug names

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 trial start date

02/02/2020

Overall trial end date

30/09/2021

Reason abandoned (if study stopped)

Eligibility

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 type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

120

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

21/10/2020

Recruitment end date

31/05/2021

Locations

Countries of recruitment

Italy

Trial participating centre

University of Milano
Department of Food, Environmental and Nutritional Sciences Via G. Celoria 2
Milano
20133
Italy

Trial participating centre

University of Torino
Department of Agricultural, Forest and Food Sciences Department of Medical Sciences Largo Paolo Braccini 2 Corso Dogliotti 14
Torino
10095/10126
Italy

Trial participating centre

University of Bari
Aldo Moro-Department of Soil, Plant, and Food Sciences Department of Biomedical Sciences and Human Oncology via G. Amendola 165/A / Piazza Giulio Cesare 11
Bari
70126/70121
Italy

Trial participating centre

Libera Università di Bolzano
Faculty of Science and Technology Piazza Università, 5
Bozen
39100
Italy

Trial participating centre

University of Naples Federico II
Department of Agricultural Sciences Division of Microbiology Via Università 100
Portici (NA)
80055
Italy

Trial participating centre

University of Bologna
Department of Pharmacy and Biotechnology Unit of Microbial Ecology of Health Via Massarenti 9
Bologna
40138
Italy

Sponsor information

Organisation

Ministry of Education, Universities and Research

Sponsor details

Viale Trastevere
76/a
Roma
00153
Italy
+39 (0)658494500
urp@istruzione.it

Sponsor type

Government

Website

http://www.miur.gov.it/

Funders

Funder type

Government

Funder name

Ministero dell’Istruzione, dell’Università e della Ricerca

Alternative name(s)

Ministry of Education, University and Research, Ministry of Education, Universities and Research, MIUR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Italy

Results and Publications

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 statement
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.

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.