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Effect of E171 (titanium dioxide) in the colon

EFFECT OF FOOD ADDITIVE E171 (TITANIUM DIOXIDE) ON THE DEVELOPMENT OF COLORECTAL CANCER, AN EARLY BIOMARKERS RESEARCH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20868
Enrollment
80
Registered
2016-05-31
Start date
2016-09-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

E171, Titanium dioxide, Gut inflammation, Biomarker E171, Titanium dioxide, Darm inflammatie, Biomarker

Interventions

This study is a cross-over design, including only healthy volunteers. A cross-over design was chosen because it is the most appropriate design for this study: it will reduce the individual differences

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: - 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

Design outcomes

Primary

MeasureTime frame
The primary outcome parameters are differences in transcriptomic markers after consumption of food additive E171. These outcomes in humans will shed light on the relevance of markers identified in preclinical studies, and how the animal data on the risk of facilitation of tumour growth can be extrapolated to humans

Secondary

MeasureTime frame
Secondary outcome parameters include inflammatory markers such as ROS in the rectal epithelium. These outcomes will help to understand the inflammatory mechanisms that may be indicative of the risk to developing colorectal cancer.

Contacts

Public ContactHéloïse Proquin
h.proquin@maastrichtuniversity.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)