Dietary HabitsMIVECANCT05621122

Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer

An observational study of Dietary Habits and Food Habits, run by Universidad de Granada at 6 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This projects aims to characterize dietary habits and nutrition quality of pro-vegetarian diets as compared to omnivorous diets. It also aims to stablish gut microbial and metabolit profiles of this dietary pattern, in order to elucidate the role of plant-based diets in cancer prevention and treatment. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dietary Habits, Food Habits, Nutrition, Healthy
What is being tested?: This is an observational study
How many people: 300 participants
Where: 6 sitesSpain
Study dates: 1 Jan 2023to 1 Dec 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: University students and staff, mainly. Healthy volunteers from the general population. The control group will be matched by age and sex to the vegetarian diet study groups.

Who may be able to join

Who cannot join

pregnancy or lactation
antibiotic treatment in the previous 2 weeks

Trial locations and contacts

6 sites in 1 country.

Esther Molina Montes contact

958240750

memolina@ugr.es

Noelia M Rodriguez Martin contact

nmrodriguez@ig.csic.es

City, postcode or hospital

Sites recruiting now only

6 sites in 1 country

Spain6 sites, 6 recruiting

Idibell Ico
Barcelona
Mireia Obon Santacana
Mireia Obon Santacana
Not yet recruiting
Biodonostia
Donostia / San Sebastian
Pilar Amiano
Pilar Amiano
Not yet recruiting
University of Granada
Granada
Esther Molina Montes, Doctor, 958240750, memolina@ugr.es
Esther Molina-Montes
Recruiting
Csic-Ictan
Madrid
Beatriz Sarria
Beatriz Sarria
Not yet recruiting
CSIC-IG
Seville
Noelia M Rodriguez Martin, nmrodriguez@ig.csic.es
Noelia M Rodriguez-Martin
Not yet recruiting
IISPV Pere Virgili
Tarragona
Raquel Cumeras
Raquel Cumeras
Not yet recruiting

Other trials in Spain

About this study

Official title: Characterizacion of Pro-VEgetarian Diets: Diet Quality and Nutrition, MIcrobial/Metabolite Profiles and Implications in CAncer (MIVECA Study)

Read the detailed description

Plant-based foods (fruits, vegetables, cereals, nuts and seeds, legumes, and vegetable oils) are the main source of fiber and other bioactive compounds in the diet. Plant-based diets are therefore assumed to prevent mortality and the ocurrence of chronic diseases including cancer. However, evidence on this issue is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known.

The main objectices of this project are:

To develop and validate dietary assessment methods for the vegetarian population
To assess dietary habits and consumer beliefs of vegetarians with respect to omnivores, considering different types of vegetarian diets
To identify a gut microbiota signature related to plant-based diets from subgroups of subjects following a plant-based diet foods (vegans, lacto-vegetarians, …, and pro-vegetarians) and omnivorous subjects (non-plant-based diets), from stool metagenomic sequencing.
To relate this signature with metabolites present in faeces (related to the presence of certain microbial species) and in urine to improve the predictive capacity of the microbial signature of vegetable diets.
Validate the signature using independent study populations, and including colorectal and breast cancer survivors as another study target.

Conditions: Dietary Habits, Food Habits, Nutrition, Healthy, Cancer, Metabolic Disease
Being tested: This is an observational study
Keywords: dietary patterns, vegetarian, omics, microbiome, cancer, metabolism
Medical subject headings: Feeding Behavior, Neoplasms, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

This is an observational studyOther
This is an observational study. The control group (omnivours) will be compared with all otgher groups

Study groups in NCT05621122
Study group	Role	What they receive
Omnivours		100 subjects (comparison group) Receives: Other: This is an observational study
Vegans		50 subjects, adults aged over 18 years, voluntarly participating in this observational study Receives: Other: This is an observational study
Lacto-ovo-vegetarians		50 subjects, adults aged over 18 years, voluntarly participating in this observational study Receives: Other: This is an observational study
Pesco-vegetarians		50 subjects, adults aged over 18 years, voluntarly participating in this observational study Receives: Other: This is an observational study
Pro-vegetarians		50 subjects, adults aged over 18 years, voluntarly participating in this observational study Receives: Other: This is an observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

Dietary habits obtention from vegetarians: the dietary intake
Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population, including novel vegetarian foods to evaluate vegetarian food consumption. The data analysis will be taken at baseline outcome.
Measured: 3 months
Dietary assessment validation methods: 24-hour-recalls and dietary intake biomarkers
To validated dietary assessment method, two 24-Hour-Recalls in two non-consecutive days will be used, as well as the analysis of specific vegetarian diet metabolites in urine and stool samples using Ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS). The data analysis will be taken at baseline. We have estimated that 200 subjects will be sufficient to detect, with a 95% confidence and power of 90%, correlation coefficients greater than rho=0.2.
Measured: 6 monts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20231 Dec 2023

First posted17 Nov 2022
Study start1 Jan 2023 (estimated)
Primary completion1 Jun 2023 (estimated)
Study completion1 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dietary HabitsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05621122
Sponsor's protocol ID: PPJIA2021-38
Acronym: MIVECA
Status last verified: Nov 2022
First submitted: 29 Sep 2022
Last updated: 25 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Esther Molina Montes

958240750

memolina@ugr.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
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PreDiabetes, Adolescent Obesity
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Dietary Habits

All Dietary Habits trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterizacion of Pro-VEgetarian Diets: Diet Quality and Nutrition, MIcrobial/Metabolite Profiles and Implications in CAncer (MIVECA Study)
ClinicalTrials.gov ID: NCT05621122
Acronym / sponsor ID: MIVECA / PPJIA2021-38
Conditions: Dietary Habits, Food Habits, Nutrition, Healthy, Cancer, Metabolic Disease
Keywords: dietary patterns, vegetarian, omics, microbiome, cancer, metabolism
Study type: Observational
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: Universidad de GranadaUniversity, hospital or other
Collaborators: Andalusian School of Public Health, Institut Investigacio Sanitaria Pere Virgili, Institut d'Investigació Biomèdica de Bellvitge, National Research Council, Spain, Instituto de Ciencia y Tecnología de Alimentos y Nutrición, University of Seville, Biodonostia Health Research Institute (Biodonostia HRI)
Study start: 1 Jan 2023 (estimated)
Primary completion: 1 Jun 2023 (estimated)
Study completion: 1 Dec 2023 (estimated)
First posted: 17 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The main objectices of this project are:

To develop and validate dietary assessment methods for the vegetarian population
To assess dietary habits and consumer beliefs of vegetarians with respect to omnivores, considering different types of vegetarian diets
To identify a gut microbiota signature related to plant-based diets from subgroups of subjects following a plant-based diet foods (vegans, lacto-vegetarians, …, and pro-vegetarians) and omnivorous subjects (non-plant-based diets), from stool metagenomic sequencing.
To relate this signature with metabolites present in faeces (related to the presence of certain microbial species) and in urine to improve the predictive capacity of the microbial signature of vegetable diets.
Validate the signature using independent study populations, and including colorectal and breast cancer survivors as another study target.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 5

Arm	Type	Receives
Omnivours	–	Other: This is an observational study100 subjects (comparison group)
Vegans	–	Other: This is an observational study50 subjects, adults aged over 18 years, voluntarly participating in this observational study
Lacto-ovo-vegetarians	–	Other: This is an observational study50 subjects, adults aged over 18 years, voluntarly participating in this observational study
Pesco-vegetarians	–	Other: This is an observational study50 subjects, adults aged over 18 years, voluntarly participating in this observational study
Pro-vegetarians	–	Other: This is an observational study50 subjects, adults aged over 18 years, voluntarly participating in this observational study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: University students and staff, mainly. Healthy volunteers from the general population. The control group will be matched by age and sex to the vegetarian diet study groups.

Key inclusion criteria (1 listed)

Key exclusion criteria (2 listed)

pregnancy or lactation
antibiotic treatment in the previous 2 weeks

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
This is an observational studyThis is an observational study. The control group (omnivours) will be compared with all otgher groups	Other	Lacto-ovo-vegetarians, Omnivours, Pesco-vegetarians, Pro-vegetarians, Vegans

Primary outcome

Dietary habits obtention from vegetarians: the dietary intake
Time frame: 3 months
Dietary habits will be taken by an online specific Food Frequency Questionnaire (FFQ) for Spanish population, including novel vegetarian foods to evaluate vegetarian food consumption. The data analysis will be taken at baseline outcome.
Dietary assessment validation methods: 24-hour-recalls and dietary intake biomarkers
Time frame: 6 monts
To validated dietary assessment method, two 24-Hour-Recalls in two non-consecutive days will be used, as well as the analysis of specific vegetarian diet metabolites in urine and stool samples using Ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS). The data analysis will be taken at baseline. We have estimated that 200 subjects will be sufficient to detect, with a 95% confidence and power of 90%, correlation coefficients greater than rho=0.2.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
Individual participant dataSharing planned: No

Related trials for Dietary Habits

Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Esther Molina Montes contact

958240750

memolina@ugr.es

Noelia M Rodriguez Martin contact

nmrodriguez@ig.csic.es

Esther Molina Montes study director

Universidad de Granada

Noelia M Rodriguez study chair

nmrodriguez@ig.csic.es

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dietary Habits and Food Habits, run by Universidad de Granada at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Esther Molina Montes (958240750, memolina@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary habits obtention from vegetarians: the dietary intake (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.