CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 78 enrolled
Drug / intervention
Processed meat product +3 moredietary
Likely dose
Drinking water containing nitrate up to acceptable daily intake level (ADI = 3.7 mg/kg bw) in combination with 300 grams of processed meat, white meat or processed meat enriched with natural compoundsfrom record
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Search/NCT04138654
NCT04138654Phase 1Completed

Natural Compounds to Reduce Nitrite in Meat Products: PHYTOME

Maastricht University·interventional·Posted Oct 24, 2019·Updated Oct 24, 2019

In Brief

A Phase 1 clinical trial evaluating Processed meat product, White meat wash-out, and 2 other interventions for Colon Cancer. Completed, enrolled 78 participants across 1 site.

Detailed Summary

The PHYTOME project (Phytochemicals to reduce nitrite in meat products) is a major European Union (EU) co-funded research project that aims to develop innovative meat products in which the food additive nitrite has been replaced by natural compounds originating from fruits and vegetables. These biologically active compounds, also referred to as phytochemicals, are known to contribute to improved gut health and are added to the meat as natural extracts. In a number of meat products, carefully selected combinations of natural antioxidants and other biologically active compounds occurring in vegetables, fruits and natural extracts such as coffee and tea, will be added during meat processing. Some of these compounds possess an antimicrobial activity allowing them to replace nitrite, whereas others possess a natural red colour that may contribute to the desired appearance of the products. Also, some of these compounds are known to protect colonic cells against damaging effects of cancer causing agents that may be formed in the large intestine after meat consumption. The PHYTOME project will develop new technologies to introduce the natural extracts during processing to different types of meat products. These techniques will guarantee good sensory quality of the product as well as microbiological safety. Once these techniques have been developed and optimized at laboratory scale, the new type of products will be produced on an industrial scale. The health promoting effects of these products will be evaluated in a human dietary intervention study with healthy volunteers. After consumption of a fully controlled diet with either relatively high amounts of the traditional meat products or products produced following the new concept, faeces and colonic material will be collected and investigated for markers of colorectal cancer risk. These investigations will be performed in close collaboration with Research Institutes in the United Kingdom, Belgium, Italy and Greece, and will make use of the newest genomics techniques that are available.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cancer
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 24, 2019
Enrollment StartApr 17, 2014
Primary CompletionJun 30, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.7 years ago

Interventions

Processed meat productdietary

300 grams per day during 2 weeks

White meat wash-outdietary

300 grams per day during 2 weeks

Processed meat products enriched with natural compoundsdietary

300 grams per day during 2 weeks

Drinking water containing nitrate up to acceptable daily intake level (ADI = 3.7 mg/kg bw) in combination with 300 grams of processed meat, white meat or processed meat enriched with natural compoundsdietary

3.7 mg nitrate/kg bw per day plus 300 grams of meat for 1 week