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Risk of intake of E171 on development of colorectal cancer

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21855
Enrollment
80
Registered
2020-04-15
Start date
2020-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

This study is a cross-over design and will be done in 4 weeks and include 2 periods. The volunteers will be randomized in two groups: one group will start with the intervention period and the other on

Sponsors

Maastricht University
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The main outcome parameter in this study is the difference in the gene expression profiles due to exposure to the food additive E171. 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

MeasureTime frame
Secondary outcome parameters include: - Inflammatory markers such as ROS in the rectal epithelium and blood. - A rectal swab will be taken in order to evaluate the effect on the microbiome.

Contacts

Public ContactSimone van Breda

Maastricht University

s.vanbreda@maastrichtuniversity.nl0031433882127

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)