Risk of intake of E171 on development of colorectal cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Healthy with a Body Mass Index (BMI) between 18-27, male or female
- Between 18-70 years old

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Alcohol abuse up to 6 months before participation in this research, i.e. more than 4 drinks on any single day and more than 14 drinks per week for men and more than 3 drinks on any single day and more than 7 drinks per week for women
- Current presence of any diseases related to the gastrointestinal tract, kidney, liver, heart or lungs
- Current presence of symptoms related to diseases of the gastrointestinal tract, i.e. vomiting, diarrhoea or constipation, and altered stool, such as blood in stool
- Current presence of diseases related to the endocrine or metabolic system
- Current presence of anaemia
- HIV infection or hepatitis
- Use of antibiotics and other prescribed medication and painkillers over the last 3 months (exception: paracetamol and contraceptive)
- Current smokers
- Vegetarians
- Pregnant women
- Participants of other intervention studies during this intervention period.
- Participants who use anticoagulant medicine

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main outcome parameter in this study is the difference in the gene expression profiles due to exposure to the food additive E171.<br>In order to evaluate the impact of the food additive E171 on gene expression changes and to modify molecular processes involved in human cancer development colon biopsies will be analysed for transcriptomic responses to the exposure to E171.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome parameters include:<br>- Inflammatory markers such as ROS in the rectal epithelium and blood. <br>- A rectal swab will be taken in order to evaluate the effect on the microbiome.