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Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05621122
Acronym
MIVECA
Enrollment
300
Registered
2022-11-17
Start date
2023-01-01
Completion date
2023-12-01
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Dietary Habits, Food Habits, Metabolic Disease, Nutrition, Healthy

Keywords

dietary patterns, vegetarian, omics, microbiome, cancer, metabolism

Brief 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.

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: 1. To develop and validate dietary assessment methods for the vegetarian population 2. To assess dietary habits and consumer beliefs of vegetarians with respect to omnivores, considering different types of vegetarian diets 3. 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. 4. 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. 5. Validate the signature using independent study populations, and including colorectal and breast cancer survivors as another study target.

Interventions

OTHERThis is an observational study

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

Sponsors

Andalusian School of Public Health
CollaboratorOTHER_GOV
Institut Investigacio Sanitaria Pere Virgili
CollaboratorOTHER
Institut d'Investigació Biomèdica de Bellvitge
CollaboratorOTHER
National Research Council, Spain
CollaboratorOTHER_GOV
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
CollaboratorOTHER_GOV
University of Seville
CollaboratorOTHER
Biodonostia Health Research Institute (Biodonostia HRI)
CollaboratorUNKNOWN
Universidad de Granada
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\-

Exclusion criteria

* pregnancy or lactation * antibiotic treatment in the previous 2 weeks

Design outcomes

Primary

MeasureTime frameDescription
Dietary habits obtention from vegetarians: the dietary intake3 monthsDietary 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 biomarkers6 montsTo 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.

Countries

Spain

Contacts

Primary ContactEsther Molina Montes
memolina@ugr.es958240750
Backup ContactNoelia M Rodriguez Martin
nmrodriguez@ig.csic.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026