Study title
Faecal microbiome as determinant of the effect of diet on colorectal-cancer risk: comparison of meat based versus pesco-vegetarian diets - WP1
Template
Intervention/Observation study
title
Faecal microbiome as determinant of the effect of diet on colorectal-cancer risk: comparison of meat based versus pesco-vegetarian diets - WP1
description
This study is part of the MEATIC project. The project is aimed at evaluating the role of gut microbiota in the correlation between diet (especially read meat consumption) and colorectal cancer (CRC). To this aim, the project is divided into 4 WPs on different experimental models or on cohort of healthy humans, but with a common dietary intervention design. In detail, the dietary intervention was structured in 3 classes: 1) red meat rich diet (high risk); 2) red meat rich diet with tocopherol (controlled risk class); 3) pesco-vegetarian diet (low risk). This study collects metadata and data of the WP1 of the MEATIC project. End-point of the project is to evaluate the fecal microbiota and the fecal metabolome, as well as different parameters connected to CRC and tumorigenesis, connected to different diet interventions. The subject of the dietary intervention was a cohort of clinically healthy adults (age 18-50, both sexes)
startDate
2019-09-11 00:00:00.0
Study type
Human Intervention
Primary endpoint
Faecal water genotoxicity (comet assay)
Objectives
valuating the role of gut microbiota in the correlation between diet (especially read meat consumption) and colorectal cancer (CRC).
Exclusion criteria
- presence of current chronic illness or unstable condition (e.g., cardiovascular disease, chronic liver disease, inflammatory bowel disease)
- current or recent (past 2 months) use of antibiotics or probiotics
- pregnancy or intention to become pregnant in the next 12 months
- lactation
- current or recent (past 2 months) adoption of a vegetarian diet
Inclusion criteria
clinically healthy subjects (age: 18-50 years, both sexes)
Was the study approved by an ethics committee?
Yes
Did the individuals providing data sign informed consent?
Yes
Full randomisation method (if any)
Computer random number generator
Treatments (Number and types of foods, drugs or other treatments compared)
- Meat-based diet (MBD) – diet including 4 servings per week of red meat (1 serving = 150 g), 3 servings per week of processed meat (1 serving = 50 g), and 1 servings per week of poultry (1 serving
= 150 g), for a total amount of 900 g per week of meat.
- Meat-based diet supplemented with alpha-tocopherol (MBD-T) – as the MBD, but supplemented with 100 mg/day of alpha-tocopherol in the form of tablet.
- Pesco-vegetarian diet (PVD) – excluding fresh and processed meat, poultry but including 3 servings per week of any type of fish, excluding shellfish (1 serving = 150 g), for a total amount of 450 g per
week. Diet will contain other sources of proteins (e.g. eggs, dairy, legumes/beans).
Start of recruitment (Start year or date)
2019-09-11 00:00:00.0
End of recruitment (End year or date)
2020-12-07 00:00:00.0
