Pro-Vegetarian Diets, Microbial/Metabolite Profiles and Cancer
- Conditions
- Nutrition, HealthyMetabolic DiseaseFood HabitsDietary HabitsCancer
- Interventions
- Other: This is an observational study
- Registration Number
- NCT05621122
- Lead Sponsor
- Universidad de Granada
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- pregnancy or lactation
- antibiotic treatment in the previous 2 weeks
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pro-vegetarians This is an observational study 50 subjects, adults aged over 18 years, voluntarly participating in this observational study Vegans This is an observational study 50 subjects, adults aged over 18 years, voluntarly participating in this observational study Omnivours This is an observational study 100 subjects (comparison group) Lacto-ovo-vegetarians This is an observational study 50 subjects, adults aged over 18 years, voluntarly participating in this observational study Pesco-vegetarians This is an observational study 50 subjects, adults aged over 18 years, voluntarly participating in this observational study
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
CSIC-IG
🇪🇸Sevilla, Spain
Biodonostia
🇪🇸Donostia, Spain
Idibell Ico
🇪🇸Barcelona, Spain
University of Granada
🇪🇸Granada, Spain
IISPV Pere Virgili
🇪🇸Tarragona, Spain
Csic-Ictan
🇪🇸Madrid, Spain