Clinical trial NCT05621122: Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer
Official title: Characterizacion of Pro-VEgetarian Diets: Diet Quality and Nutrition, MIcrobial/Metabolite Profiles and Implications in CAncer (MIVECA Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dietary Habits
Food Habits
Nutrition, Healthy
Cancer
Metabolic Disease
Keywords: dietary patterns
vegetarian
omics
microbiome
cancer
metabolism
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Andalusian School of Public Health
name: Institut Investigacio Sanitaria Pere Virgili
name: Institut d'Investigació Biomèdica de Bellvitge
name: National Research Council, Spain
name: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
name: University of Seville
name: Biodonostia Health Research Institute (Biodonostia HRI)
First posted: 2022-11-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

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

Primary outcomes:
measure: Dietary habits obtention from vegetarians: the dietary intake
timeFrame: 3 months
measure: Dietary assessment validation methods: 24-hour-recalls and dietary intake biomarkers
timeFrame: 6 monts
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Idibell Ico
city: Donostia
country: Spain
facility: Biodonostia
city: Granada
country: Spain
facility: University of Granada
city: Madrid
country: Spain
facility: Csic-Ictan
city: Sevilla
country: Spain
facility: CSIC-IG
city: Tarragona
country: Spain
facility: IISPV Pere Virgili
Study officials:
affiliation: Universidad de Granada
name: Esther Molina Montes
role: STUDY_DIRECTOR
affiliation: nmrodriguez@ig.csic.es
name: Noelia M Rodriguez
role: STUDY_CHAIR
References: