Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom
NCT Number: NCT03944421
This study will evaluate the effects of substituting red and processed meat in the diet with Quorn; a meat replacement product, on biomarkers of gut health. This will be a crossover design where participants will take part in 2 study periods where they will consume a diet containing red and processed meat during one of the study periods, whereas in the other study period, they will consume a diet containing Quorn.
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Notify Me18 year–50 year
Male
Interventional
Not applicable
Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom
There is a strong association between a diet which is high in red and processed meat, while low in fibre, and the incidence of colorectal cancer. This study aims to evaluate the effects of replacing red and processed meat in the diet with an alternative meat product such as Quorn, on biomarkers of gut health that may be associated with colorectal cancer.
Quorn is a product which has a considerable fibre component; thus, the replacement of red and processed meat with Quorn, will not only reduce the amount of compounds implicated to have deleterious effects in the gastrointestinal tract (E.G. haem, nitroso compounds, heterocyclic amines), but will also increase the delivery of fibre into the gastrointestinal system, that may well have an overall positive impact on gut health.
In this study, the participants will consume 240 grams (raw weight) of either red and processed meat, or Quorn each day for a 2 week period, this will be followed by a 4 week period where they will return to their usual dietary habits; before swapping to consume the alternative food (red/processed meat or Quorn) for another 2 week period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.
Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.
Other names: Quorn Food
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Changes in the DNA damage causing capacity of aqueous stool extracts, assessed against HT29 and Caco-2 cells using the Comet assay.
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Changes in the concentration of 8-Hydroxyguanosine levels in urine samples.
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Changes from baseline in the concentration of short chain fatty acids in stool samples, measures of propionate, acetate, butyrate valerate and isovalerate via Gas Chromatography.
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Evaluation of post-intervention changes in the composition of the stool microbiota composition from baseline samples.
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Change in the concentration of the genotoxic metabolite para-cresol in urine samples
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Evaluation of change in the abundance of microRNAs in plasma separated from blood samples following the intervention.
Time frame: 2 weeks
Changes in levels of cholesterol in blood samples
Time frame: 2 weeks
Changes in levels of glucose in blood samples (HbA1c)
Northumbria University
Other
The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health
Acronym: MYCOMEAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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