Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer (MIVECA)

University of Granada (UGR)

Status: Enrolling

Conditions: Dietary Habits; Food Habits; Metabolic Disease; Cancer; Nutrition, Healthy

Treatments: Other: This is an observational study

Study type: Observational

Funder types: Other

Identifiers

NCT05621122

PPJIA2021-38

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

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

Trial design

300 participants in 5 patient groups

Omnivours

Description:

100 subjects (comparison group)

Treatment:

Other: This is an observational study

Vegans

Description:

50 subjects, adults aged over 18 years, voluntarly participating in this observational study

Treatment:

Other: This is an observational study

Lacto-ovo-vegetarians

Description:

50 subjects, adults aged over 18 years, voluntarly participating in this observational study

Treatment:

Other: This is an observational study

Pesco-vegetarians

Description:

50 subjects, adults aged over 18 years, voluntarly participating in this observational study

Treatment:

Other: This is an observational study

Pro-vegetarians

Description:

50 subjects, adults aged over 18 years, voluntarly participating in this observational study

Treatment:

Other: This is an observational study