Effect of food additive E171 (titanium dioxide) on the development of colorectal cancer, an early biomarkers research.

Recruiting

Conditions: colon inflammation
gut inflammation
10017969

Registration Number: NL-OMON54542

Lead Sponsor: niversitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Healthey volonteers with a Body Mass Index (BMI) between 18-27, male or femelle
and between 18-70 years old

Exclusion Criteria

- 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 anti-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
<p>The primary outcome parameters are differences in transcriptomic markers after<br /><br>consumption of food additive E171. These outcomes in humans will demonstrate if<br /><br>the intake of E171 in humans results in changes in molecular processes that are<br /><br>associated with increased colorectal cancer risk. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters include inflammatory markers such as ROS in the<br /><br>rectal epithelium. These outcomes will help to understand the inflammatory<br /><br>mechanisms that may be indicative of the risk to developing colorectal cancer. </p><br>