Investigating whether a person's genes or sex affects the range of microbes in their gut when they eat a Mediterranean or Western diet
| ISRCTN | ISRCTN73075133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73075133 |
| Secondary identifying numbers | PCT4E-19 |
- Submission date
- 25/12/2019
- Registration date
- 02/01/2020
- Last edited
- 03/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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) and FISABIO (Spain)
When is the study starting and how long is it expected to run for?
January 2019 to February 2022
Who is funding the study?
FISABIO (Spain) , University of Valencia (Spain), CIBEROBN (Spain) and CIBERESP (Spain)
Who is the main contact?
Professor Dolores Corella, dolores.corella@uv.es
Contact information
Scientific
University of Valencia and CIBER OBN
Blasco Ibanez, 15
Valencia
46010
Spain
 ORCID ID |
0000-0002-2366-4104 |
|---|---|
| Phone | +34 963864800 |
| dolores.corella@uv.es |
Scientific
FISABIO and CIBERESP
Avda de Cataluña 21
Valencia
46020
Spain
| ORCID ID |
0000-0003-0460-1105 |
|---|---|
| Phone | +34 96 1925965 |
| gosalbes_mjo@gva.es |
Study information
| 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 |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet. |
| Scientific title | Microbiome-Genome interaction in two dietary contexts with a gender perspective |
| Study acronym | MicroGenDiet |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Current primary outcome measures as of 03/01/2023: 1. Composition of bacteria and fungi in stool samples assessed using DNA sequencing at baseline and 6 months 2. Metabolic functions of the microbiota assessed using bioinformatic tools at baseline and 6 months 3. Host genomic profile assessed using a genome-wide genotyping array at baseline _____ Previous primary outcome measures: 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 | Current primary outcome measures as of 03/01/2023: 1. Host genome-wide determinations assessed by microarray at baseline 2. Blood pressure measured using standard methods at baseline and longitudinally at 6 months 3. Weight measured using validated scales and bioimpedance at baseline and 6 months 4. Height measured using standard methods at baseline and 6 months 5. Waist circumference measured using standard methods at baseline and 6 months 6. Body composition measured by bioimpedance at baseline and 6 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 6 months 8. Dietary intake assessed using dietary questionnaires (24-h recalls and food frequency questionnaires) at baseline and 6 months 9. Physical activity measured using the short form of the Minnesota physical activity questionnaire at baseline and 6 months 10. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire at baseline and after 6 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 6 months 13. Plasma lipids measured using standard methods at baseline and after 6 months 14. Fasting glucose measured using colorimetric methods at baseline and after 6 months 15. Bilirubin measured using colorimetric methods at baseline and after 6 months 16. Blood counts measured using standard methods at baseline and after 6 months _____ Previous 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 study start date | 27/01/2019 |
| Completion date | 15/02/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 100 participants (50 in each dietary group) |
| Total final enrolment | 102 |
| Key inclusion criteria | 1. Aged 18-75 years with 50% females 2. Has a dietary profile (Mediterranean diet or Western diet) |
| Key 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 |
| Date of first enrolment | 30/12/2019 |
| Date of final enrolment | 01/07/2021 |
Locations
Countries of recruitment
- Spain
Study participating centres
Valencia
46010
Spain
Valencia
46020
Spain
Pabellon 11
Madrid
28029
Spain
Pabellon 11
Madrid
28029
Spain
Sponsor information
Research organisation
Avda de Cataluña, 21
Valencia
46020
Spain
| Phone | +34 96 1926318 |
|---|---|
| ros_ali@gva.es | |
| Website | http://fisabio.san.gva.es/ |
University/education
Avda Blasco Ibanez, 15
Valencia
46010
Spain
| Phone | +34 963864100 |
|---|---|
| francisco.gimenez@uv.es | |
| Website | http://www.uv.es/ |
Research organisation
Monforte de Lemos 2-5
Madrid
28028
Spain
| Phone | +34963864100 |
|---|---|
| jose.sorli@uv.es |
Research organisation
Monforte de Lemos 3-5
Madrid
28029
Spain
| Phone | +34 96 1925965 |
|---|---|
| gosalbes_mjo@gva.es | |
| Website | http://www.ciberesp.es/ |
Funders
Funder type
Research organisation
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 15/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results will be presented in scientific meetings and published in international journals. |
| IPD sharing plan | 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. |
Editorial Notes
03/01/2023: The following changes have been made:
1. Recruitment resumed on 02/11/2020.
2. The primary outcome measures have been changed.
3. The secondary outcome measures have been changed
4. The recruitment end date has been changed from 30/06/2020 to 01/07/2021.
5. The overall trial end date has been changed from 31/12/2021 to 15/02/2022 and the plain English summary updated accordingly.
6. The intention to publish date has been changed from 30/03/2022 to 15/07/2023.
7. The final enrolment number has been added.
21/04/2020: One of the scientific contacts' details have been changed.
20/04/2020: The following changes have been made:
1. One of the scientific contacts' details have been changed.
2. CIBERESP has been added as a trial participating centre.
3. FISABIO's sponsor contact details have been changed.
4. CIBERESP has been added as a sponsor.
5. CIBERESP has been added as a funder.
6. The plain English summary has been updated to reflect these changes.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
02/01/2020: Trial's existence confirmed by the University of Valencia Ethics Committee for Research in Humans.
