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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

300

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach

1 country

6 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

September 29, 2022

Completed

2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

September 29, 2022

Last Update Submit

November 20, 2022

Conditions

Dietary Habits Food Habits Nutrition, Healthy Cancer Metabolic Disease

Keywords

dietary patternsvegetarianomicsmicrobiomecancermetabolism

Outcome Measures

Primary Outcomes (2)

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