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ClinicalTrials.gov ID

NCT05621122

Lead Sponsor

Universidad de GranadaOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Nov 25, 2022Actual

Start Date

Jan 1, 2023Estimated

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

Official Title

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

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.

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

• This is an observational study

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

-

Exclusion Criteria:

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

Observational Model

Case-Control

Time Perspective

Retrospective

Lead Sponsor

Universidad de GranadaOTHER

Collaborators

Andalusian School of Public HealthOTHER_GOV

Institut Investigacio Sanitaria Pere VirgiliOTHER

Institut d'Investigació Biomèdica de BellvitgeOTHER

National Research Council, SpainOTHER_GOV

Instituto de Ciencia y Tecnología de Alimentos y NutriciónOTHER_GOV

University of SevilleOTHER

Biodonostia Health Research Institute (Biodonostia HRI)UNKNOWN

nmrodriguez@ig.csic.es