Condition or disease | Intervention/treatment | Phase |
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Colorectal Cancer | Other: Red and Processed Meat Other: Quorn | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Prevention |
Official Title: | The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health |
Actual Study Start Date : | July 3, 2019 |
Actual Primary Completion Date : | January 29, 2020 |
Actual Study Completion Date : | January 29, 2020 |
Arm | Intervention/treatment |
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Experimental: Red and Processed Meat
240 grams (raw weight) of red and processed meat every day for 2 weeks
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Other: Red and Processed Meat
Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.
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Experimental: Quorn
240 grams (uncooked weight) of Quorn every day for 2 weeks
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Other: Quorn
Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.
Other Name: Quorn Food
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Northumbria University | |
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST |
Principal Investigator: | daniel M commane, PhD | Northumbria University |
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | March 5, 2019 | ||||||||||||||
First Posted Date ICMJE | May 9, 2019 | ||||||||||||||
Last Update Posted Date | June 1, 2020 | ||||||||||||||
Actual Study Start Date ICMJE | July 3, 2019 | ||||||||||||||
Actual Primary Completion Date | January 29, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Genotoxic potential of Faecal extracts from volunteers consuming intervention diets rich in red and processed meat versus diets containing Quorn [ 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health | ||||||||||||||
Official Title ICMJE | The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health | ||||||||||||||
Brief Summary | 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. | ||||||||||||||
Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Colorectal Cancer | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||
Actual Enrollment ICMJE |
20 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Actual Study Completion Date ICMJE | January 29, 2020 | ||||||||||||||
Actual Primary Completion Date | January 29, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United Kingdom | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03944421 | ||||||||||||||
Other Study ID Numbers ICMJE | NorthumbriaU001 | ||||||||||||||
Has Data Monitoring Committee | Not Provided | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Northumbria University | ||||||||||||||
Study Sponsor ICMJE | Northumbria University | ||||||||||||||
Collaborators ICMJE | Quorn | ||||||||||||||
Investigators ICMJE |
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PRS Account | Northumbria University | ||||||||||||||
Verification Date | May 2019 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |