Condition category
Digestive System
Date applied
25/12/2019
Date assigned
02/01/2020
Last edited
02/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The gut microbiome is the ecosystem of bacteria, fungi and other microorganisms that live in a person's gut. It is complex and highly individual. The variety of microbes present depends on some factors that cannot be changed, such as a person's genetic make-up, sex and age, as well as factors such as diet, illness and drug treatment. It is not currently known how to change the composition of the microbiome through diet.
This trial aims to investigate the gut microbiome in people who eat a Mediterranean diet and those who eat a Western, non-Mediterranean diet to explore whether there are any patterns or any genes that are associated with a healthy gut microbiome.

Who can participate?
Men and women aged 18-75 years who eat either a Mediterranean diet or a Western, non-Mediterranean diet

What does the study involve?
The participants will provide a stool sample and a blood sample before the start of the study. They will have some physical measurements taken (height, weight, waist circumference) and will also fill in questionnaires asking about their diet, physical activity, sleep etc.They will be asked to continue to eat a Mediterranean diet or a Western, non-Mediterranean diet for 8 months and will then provide the samples and measurements and fill out the questionnaires again.

What are the possible benefits and risks of participating?
In this study, no risks or benefits to participants are expected.

Where is the study run from?
University of Valencia (Spain)

When is the study starting and how long is it expected to run for?
January 2019 to December 2021

Who is funding the study?
FISABIO (Spain) , University of Valencia (Spain) and CIBEROBN (Spain)

Who is the main contact?
Professor Dolores Corella, dolores.corella@uv.es


Trial website

Contact information

Type

Scientific

Primary contact

Prof Dolores Corella

ORCID ID

http://orcid.org/0000-0002-2366-4104

Contact details

University of Valencia and CIBER OBN
Blasco Ibanez
15
Valencia
46010
Spain
+34 963864800
dolores.corella@uv.es

Type

Scientific

Additional contact

Dr M. Jose Gosalbez

ORCID ID

Contact details

FISABIO
Avda de Cataluña 21
Valencia
46020
Spain
+34 961 925 700
gosalbes_mjo@gva.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PCT4E-19

Study information

Scientific title

Microbiome-Genome interaction in two dietary contexts with a gender perspective

Acronym

MicroGenDiet

Study hypothesis

The intestinal microbiome is a complex and dynamic ecosystem that has co-evolved with humans. However, its composition presents a great interindividual variability, being influenced by a series of intrinsic factors such as the age, sex and genotype of the individual and extrinsic factors such as diet, antibiotics or health status. Diet is the environmental factor that has the greatest effect on the composition of the intestinal microbiota. However, the interindividual variability makes it difficult to use diet as a modulating tool to correct the alteration of the microbiota associated with different pathologies since, in many cases, the response is specific to each individual. In our proposal we will address the problem of inter-individual variability of the microbiome by evaluating the effect of genetic determinants and sex on the composition and function of the microbiota in the framework of two types of diets, Mediterranean diet and Western diet.

Ethics approval

Approved 05/12/2019, Ethics Committee of Human Research at the University of Valencia (Avenida Blasco Ibáñez, 13, Valencia 46010, Spain; +34 963864109; vicerec.investigacio@uv.es), ref: UV-INV_ETICA1206333

Study design

A longitudinal study will be carried out. Samples and data will be obtained at baseline and after 8-months of follow-up. Two groups of diets will be compared in an observational design. Mendelian randomization will be used for some analyses.

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Gut microbiome in people following two dietary patterns

Intervention

A longitudinal study will be carried out. Samples and data will be obtained at baseline and after 8 months of follow-up. Two groups of diets will be compared in an observational design. Mendelian randomization will be used for some analyses.
Two dietary patterns (high adherence to the Mediterranean diet group and low adherence to the Mediterranean diet group/Western dietary pattern) will be investigated.
A screening of compliance criteria for volunteers will be carried out. A validated Mediterranean diet adherence questionnaire will be administered and according to the score, the person will be included or not in the dietary groups. After this classification at baseline, subjects will receive advice to maintain their usual dietary pattern for 8 months of follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Composition of bacteria and fungi in stool samples assessed using DNA sequencing at baseline and 8 months
2. Metabolic functions of the microbiota assessed using bioinformatic tools at baseline and 8 months
3. Host genomic profile assessed using a genome-wide genotyping array at baseline

Secondary outcome measures

1. Host genome-wide determinations assessed by microarray at baseline
2. Blood pressure measured using standard methods at baseline and longitudinally at 8 months
3. Weight measured using validated scales and bioimpedance at baseline and 8 months
4. Height measured using standard methods at baseline and 8 months
5. Waist circumference measured using standard methods at baseline and 8 months
6. Body composition measured by bioimpedance at baseline and 8 months
7. Food intake and adherence to the Mediterranean diet will be measured using the 14-item Mediterranean diet adherence PREDIMED score at baseline and 8 months
8. Dietary intake assessed using dietary questionnaires (24-h recalls and food frequency questionnaires) at baseline and 8 months
9. Physical activity measured using the short form of the Minnesota physical activity questionnaire at baseline and 8 months
10. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire at baseline and after 8 months
11. Chronotype (i.e. morning or evening person) measured using the Horne and Östberg questionnaire at baseline
12. Cognitive function measured using the TMT-A, TMT-B, COWAT and Wechsler Adult Intelligence Scale-III tests at baseline and after 8 months
13. Plasma lipids measured using standard methods at baseline and after 8 months
14. Fasting glucose measured using colorimetric methods at baseline and after 8 months
15. Bilirubin measured using colorimetric methods at baseline and after 8 months
16. Blood counts measured using standard methods at baseline and after 8 months

Overall trial start date

27/01/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18-75 years with 50% females
2. Has a dietary profile (Mediterranean diet or Western diet)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100 participants (50 in each dietary group)

Participant exclusion criteria

1. Received antibiotics or prebiotics or probiotics in the last 6 months
2. Diseased
3. Immunodeficient or HIV-positive
4. Liver cirrhosis or chronic renal failure
5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc
6. Any severe co-morbid condition
7. Alcohol abuse or addiction
8. History of major organ transplantation
9. Concurrent therapy with immunosuppressive drugs or cytotoxic agents
10. Current treatment with systemic corticosteroids
11. Current use of weight loss medication
12. Patients with an acute infection or inflammation
13. Pregnant or breastfeeding women
14. Any other condition that may interfere with the completion of the study protocol


Recruitment start date

30/12/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

Spain

Trial participating centre

University of Valencia
Blasco Ibanez, 15
Valencia
46010
Spain

Trial participating centre

FISABIO
Avda. de Catalunya, 21
Valencia
46020
Spain

Trial participating centre

CIBEROBN
Monforte de Lemos 3-5 Pabellon 11
Madrid
28029
Spain

Sponsor information

Organisation

FISABIO

Sponsor details

Avda de Cataluña
21
Valencia
46020
Spain
+34 961 925 700
gosalbes_mjo@gva.es

Sponsor type

Research organisation

Website

Organisation

University of Valencia

Sponsor details

Avda Blasco Ibanez
15
Valencia
46010
Spain
+34 963864100
francisco.gimenez@uv.es

Sponsor type

University/education

Website

http://www.uv.es/

Organisation

CIBEROBN

Sponsor details

Monforte de Lemos 2-5
Madrid
28028
Spain
+34963864100
jose.sorli@uv.es

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

FISABIO

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Valencia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CIBEROBN

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be presented in scientific meetings and published in international journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to restrictions in the informed consent. Participants did not consent to share data.

Intention to publish date

30/03/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/01/2020: Trial's existence confirmed by the University of Valencia Ethics Committee for Research in Humans.