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

Sponsor
Universidad de Granada (Other)
Overall Status
Recruiting
CT.gov ID
NCT05621122
Collaborator
Andalusian School of Public Health (Other), Institut Investigacio Sanitaria Pere Virgili (Other), Institut d'Investigació Biomèdica de Bellvitge (Other), National Research Council, Spain (Other), Instituto de Ciencia y Tecnología de Alimentos y Nutrición (Other), University of Seville (Other), Biodonostia Health Research Institute (Biodonostia HRI) (Other)
300
6
11
50
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Characterizacion of Pro-VEgetarian Diets: Diet Quality and Nutrition, MIcrobial/Metabolite Profiles and Implications in CAncer (MIVECA Study)
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Dietary habits obtention from vegetarians: the dietary intake [3 months]

    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.

  2. Dietary assessment validation methods: 24-hour-recalls and dietary intake biomarkers [6 monts]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Exclusion Criteria:
  • pregnancy or lactation

  • antibiotic treatment in the previous 2 weeks

Contacts and Locations

Locations

Site City State Country Postal Code
1 Idibell Ico Barcelona Spain
2 Biodonostia Donostia Spain
3 University of Granada Granada Spain
4 Csic-Ictan Madrid Spain
5 CSIC-IG Sevilla Spain
6 IISPV Pere Virgili Tarragona Spain

Sponsors and Collaborators

  • Universidad de Granada
  • Andalusian School of Public Health
  • Institut Investigacio Sanitaria Pere Virgili
  • Institut d'Investigació Biomèdica de Bellvitge
  • National Research Council, Spain
  • Instituto de Ciencia y Tecnología de Alimentos y Nutrición
  • University of Seville
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esther Molina-Montes, Professor (Assistant), Universidad de Granada
ClinicalTrials.gov Identifier:
NCT05621122
Other Study ID Numbers:
  • PPJIA2021-38
First Posted:
Nov 17, 2022
Last Update Posted:
Nov 25, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esther Molina-Montes, Professor (Assistant), Universidad de Granada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2022