Trial Title:
Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer
NCT ID:
NCT05621122
Condition:
Dietary Habits
Food Habits
Nutrition, Healthy
Cancer
Metabolic Disease
Conditions: Official terms:
Metabolic Diseases
Conditions: Keywords:
dietary patterns
vegetarian
omics
microbiome
cancer
metabolism
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
This is an observational study
Description:
This is an observational study. The control group (omnivours) will be compared with all
otgher groups
Arm group label:
Lacto-ovo-vegetarians
Arm group label:
Omnivours
Arm group label:
Pesco-vegetarians
Arm group label:
Pro-vegetarians
Arm group label:
Vegans
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Exclusion Criteria:
- pregnancy or lactation
- antibiotic treatment in the previous 2 weeks
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Idibell Ico
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Mireia Obon Santacana
Investigator:
Last name:
Mireia Obon Santacana
Email:
Sub-Investigator
Facility:
Name:
Biodonostia
Address:
City:
Donostia
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Pilar Amiano
Investigator:
Last name:
Pilar Amiano
Email:
Sub-Investigator
Facility:
Name:
University of Granada
Address:
City:
Granada
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Esther Molina Montes, Doctor
Phone:
958240750
Email:
memolina@ugr.es
Investigator:
Last name:
Esther Molina-Montes
Email:
Principal Investigator
Investigator:
Last name:
Maria Dolores Ruiz Lopez
Email:
Sub-Investigator
Investigator:
Last name:
Reyes Artacho
Email:
Sub-Investigator
Investigator:
Last name:
Belen Garcia-Villanova
Email:
Sub-Investigator
Investigator:
Last name:
Vito Verardo
Email:
Sub-Investigator
Investigator:
Last name:
Maria Jose Sanchez Perez
Email:
Sub-Investigator
Investigator:
Last name:
Miguel Rodriguez Barranco
Email:
Sub-Investigator
Facility:
Name:
Csic-Ictan
Address:
City:
Madrid
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Beatriz Sarria
Investigator:
Last name:
Beatriz Sarria
Email:
Sub-Investigator
Facility:
Name:
CSIC-IG
Address:
City:
Sevilla
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Noelia M Rodriguez Martin
Email:
nmrodriguez@ig.csic.es
Investigator:
Last name:
Noelia M Rodriguez-Martin
Email:
Principal Investigator
Investigator:
Last name:
Justo J Pedroche Jimenez
Email:
Sub-Investigator
Investigator:
Last name:
Ana L Lemus-Conejo
Email:
Sub-Investigator
Investigator:
Last name:
Rocio M Toscano Sanchez
Email:
Sub-Investigator
Facility:
Name:
IISPV Pere Virgili
Address:
City:
Tarragona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Raquel Cumeras
Investigator:
Last name:
Raquel Cumeras
Email:
Sub-Investigator
Start date:
January 1, 2023
Completion date:
December 1, 2023
Lead sponsor:
Agency:
Universidad de Granada
Agency class:
Other
Collaborator:
Agency:
Andalusian School of Public Health
Agency class:
Other
Collaborator:
Agency:
Institut Investigacio Sanitaria Pere Virgili
Agency class:
Other
Collaborator:
Agency:
Institut d'Investigació Biomèdica de Bellvitge
Agency class:
Other
Collaborator:
Agency:
National Research Council, Spain
Agency class:
Other
Collaborator:
Agency:
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Agency class:
Other
Collaborator:
Agency:
University of Seville
Agency class:
Other
Collaborator:
Agency:
Biodonostia Health Research Institute (Biodonostia HRI)
Agency class:
Other
Source:
Universidad de Granada
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05621122
