Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer

Cancer Clinical Trial

— MIVECA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621122
• Other study ID #: PPJIA2021-38
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2022
• Source: Universidad de Granada
• Contact: Esther Molina Montes
• Phone: 958240750
• Email: memolina[@]ugr.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• pregnancy or lactation

• antibiotic treatment in the previous 2 weeks

Related Conditions & MeSH terms

• Cancer
• Dietary Habits
• Food Habits
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• This is an observational study
This is an observational study. The control group (omnivours) will be compared with all otgher groups

Locations

Country	Name	City	State
Spain	Idibell Ico	Barcelona
Spain	Biodonostia	Donostia
Spain	University of Granada	Granada
Spain	Csic-Ictan	Madrid
Spain	CSIC-IG	Sevilla
Spain	IISPV Pere Virgili	Tarragona

Sponsors (8)

Lead Sponsor	Collaborator
Universidad de Granada	Andalusian School of Public Health, Biodonostia Health Research Institute (Biodonostia HRI), Institut d'Investigació Biomèdica de Bellvitge, Institut Investigacio Sanitaria Pere Virgili, Instituto de Ciencia y Tecnología de Alimentos y Nutrición, National Research Council, Spain, University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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