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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Dietary Habits; Metabolic Disease; Food Habits; Nutrition, Healthy
• Intervention / Treatment: Other: This is an observational study

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Esther Molina Montes; Phone Number: 958240750; Email: memolina@ugr.es
• Study Contact Backup: Name: Noelia M Rodriguez Martin; Email: nmrodriguez@ig.csic.es

Study Locations

• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • Idibell Ico
    • Contact: Mireia Obon Santacana
    • Sub-Investigator: Mireia Obon Santacana
  • Donostia, Spain
    • Not yet recruiting
    • Biodonostia
    • Contact: Pilar Amiano
    • Sub-Investigator: Pilar Amiano
  • Granada, Spain
    • Recruiting
    • University of Granada
    • Contact: Esther Molina Montes, Doctor; Phone Number: 958240750; Email: memolina@ugr.es
    • Principal Investigator: Esther Molina-Montes
    • Sub-Investigator: Maria Dolores Ruiz Lopez
    • Sub-Investigator: Reyes Artacho
    • Sub-Investigator: Belen Garcia-Villanova
    • Sub-Investigator: Vito Verardo
    • Sub-Investigator: Maria Jose Sanchez Perez
    • Sub-Investigator: Miguel Rodriguez Barranco
  • Madrid, Spain
    • Not yet recruiting
    • Csic-Ictan
    • Contact: Beatriz Sarria
    • Sub-Investigator: Beatriz Sarria
  • Sevilla, Spain
    • Not yet recruiting
    • CSIC-IG
    • Contact: Noelia M Rodriguez Martin; Email: nmrodriguez@ig.csic.es
    • Principal Investigator: Noelia M Rodriguez-Martin
    • Sub-Investigator: Justo J Pedroche Jimenez
    • Sub-Investigator: Ana L Lemus-Conejo
    • Sub-Investigator: Rocio M Toscano Sanchez
  • Tarragona, Spain
    • Not yet recruiting
    • IISPV Pere Virgili
    • Contact: Raquel Cumeras
    • Sub-Investigator: Raquel Cumeras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

-

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Omnivours; 100 subjects (comparison group)	Other: This is an observational study; This is an observational study. The control group (omnivours) will be compared with all otgher groups
Vegans; 50 subjects, adults aged over 18 years, voluntarly participating in this observational study	Other: This is an observational study; This is an observational study. The control group (omnivours) will be compared with all otgher groups
Lacto-ovo-vegetarians; 50 subjects, adults aged over 18 years, voluntarly participating in this observational study	Other: This is an observational study; This is an observational study. The control group (omnivours) will be compared with all otgher groups
Pesco-vegetarians; 50 subjects, adults aged over 18 years, voluntarly participating in this observational study	Other: This is an observational study; This is an observational study. The control group (omnivours) will be compared with all otgher groups
Pro-vegetarians; 50 subjects, adults aged over 18 years, voluntarly participating in this observational study	Other: This is an observational study; This is an observational study. The control group (omnivours) will be compared with all otgher groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary habits obtention from vegetarians: the dietary intake	Dietary 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.	3 months
Dietary assessment validation methods: 24-hour-recalls and dietary intake biomarkers	To 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.	6 monts

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: Institut d'Investigació Biomèdica de Bellvitge; University of Seville; National Research Council, Spain; Institut Investigacio Sanitaria Pere Virgili; Andalusian School of Public Health; Instituto de Ciencia y Tecnología de Alimentos y Nutrición; Biodonostia Health Research Institute (Biodonostia HRI)
• Investigators: Study Director: Esther Molina Montes, Universidad de Granada; Study Chair: Noelia M Rodriguez, nmrodriguez@ig.csic.es

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: cancer; metabolism; microbiome; vegetarian; omics; dietary patterns
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: PPJIA2021-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No