Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer

Study Overview
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Brief Summary
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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
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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: To develop and validate dietary assessment methods for the vegetarian population To assess dietary habits and consumer beliefs of vegetarians with respect to omnivores, considering different types of vegetarian diets 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. 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. Validate the signature using independent study populations, and including colorectal and breast cancer survivors as another study target.

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

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

Intervention / Treatment
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* Other: This is an observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: pregnancy or lactation antibiotic treatment in the previous 2 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary patterns, vegetarian, omics, microbiome, cancer, metabolism