Colorectal CancerMYCOMEATNCT03944421
The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health
A study testing Red and Processed Meat and Quorn in people with Colorectal Cancer, run by Northumbria University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Red and Processed Meat and Quorn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2019to 29 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-50 years.
- Not been diagnosed with colorectal cancer, or adenomas.
- Habitual omnivorous dietary pattern.
- BMI ≥18-30 kg/m2.
- Blood HbA1c <58mmol/mol (<6.5%) (not diagnosed with diabetes)
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- Fasting total cholesterol<7.8 mmol/l
- Triglycerides <2.3 mmol/l
- Normal liver function (assessed by measuring liver enzymes in the screening blood sample).
- Blood pressure lower than BP <140/90 mmHg.
- Not suffering any cardiovascular diseases/ heart diseases e.g. stroke in the past 12 months.
- Do not suffer from chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, coeliac disease)
- Do not take supplements or medication that effects gastrointestinal health
- Not participated in a pre-/probiotic or laxative trial within the previous 3 months.
- Not been prescribed and/or taken antibiotics in the previous 6 months.
- No history of alcohol misuse based on self-reported alcohol intake and measurement of liver enzymes in the screening blood sample.
Who cannot join
- Been diagnosed with colorectal cancer and/or colorectal adenomas.
- Been diagnosed with gastrointestinal disorders (e.g. Inflammatory bowel disease, irritable bowel syndrome, coeliac disease)
- Adherence to a dietary pattern which excludes foods from an animal origin.
- Abnormal blood biochemistry based on standard clinical cut- offs, as well as blood markers not fitting the inclusion criteria set.
- Have history of food intolerances/allergies (e.g. gluten or dairy) or intolerances (e.g. lactose).
- Taking, or unwilling to stop taking anti-oxidant supplements (e.g. vitamin C, vitamin E, Multivitamin tablets, polyphenol supplements)
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- Received antibiotics in the previous 6 months.
- Have participated in similar dietary or prebiotic/probiotics study in the previous 3 months.
- Current smoker.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Red and Processed Meat, Quorn
- Keywords
- Genotoxicity, DNA damage, Gut Microbiota, Metabolites
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red and Processed MeatOther
Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.
QuornOther
Also called Quorn Food
Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.
| Study group | Role | What they receive |
|---|---|---|
| Red and Processed Meat | Experimental | 240 grams (raw weight) of red and processed meat every day for 2 weeks Receives: Other: Red and Processed Meat |
| Quorn | Experimental | 240 grams (uncooked weight) of Quorn every day for 2 weeks Receives: Other: Quorn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotoxic potential of Faecal extracts from volunteers consuming intervention diets rich in red and processed meat versus diets containing Quorn
Changes in the DNA damage causing capacity of aqueous stool extracts, assessed against HT29 and Caco-2 cells using the Comet assay.
Measured: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Secondary outcomes (5)
Oxidative Damage
Changes in the concentration of 8-Hydroxyguanosine levels in urine samples.
Measured: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Endogenous Short Chain Fatty Acid Production
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.
Measured: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Gut Microbial Composition
Evaluation of post-intervention changes in the composition of the stool microbiota composition from baseline samples.
Measured: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Endogenous Production of Para-Cresol
Change in the concentration of the genotoxic metabolite para-cresol in urine samples
Measured: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Changes in MicroRNA Expression
Evaluation of change in the abundance of microRNAs in plasma separated from blood samples following the intervention.
Measured: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start3 Jul 2019
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Quorn
- Responsible party
- Sponsor
- Investigators
- daniel M commane, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944421
- Sponsor's protocol ID
- NorthumbriaU001
- Acronym
- MYCOMEAT
- Status last verified
- May 2019
- First submitted
- 5 Mar 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Farsi DN, Gallegos JL, Finnigan TJA, Cheung W, Munoz JM, Commane DM. The effects of substituting red and processed meat for mycoprotein on biomarkers of cardiovascular risk in healthy volunteers: an analysis of secondary endpoints from Mycomeat. Eur J Nutr. 2023 Dec;62(8):3349-3359. doi: 10.1007/s00394-023-03238-1. Epub 2023 Aug 25.
PubMed 37624376Farsi DN, Gallegos JL, Koutsidis G, Nelson A, Finnigan TJA, Cheung W, Munoz-Munoz JL, Commane DM. Substituting meat for mycoprotein reduces genotoxicity and increases the abundance of beneficial microbes in the gut: Mycomeat, a randomised crossover control trial. Eur J Nutr. 2023 Apr;62(3):1479-1492. doi: 10.1007/s00394-023-03088-x. Epub 2023 Jan 18.
PubMed 36651990
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health
- ClinicalTrials.gov ID
- NCT03944421
- Acronym / sponsor ID
- MYCOMEAT / NorthumbriaU001
- Conditions
- Colorectal Cancer
- Keywords
- Genotoxicity, DNA damage, Gut Microbiota, Metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Quorn
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red and Processed Meat | Experimental | Other: Red and Processed Meat240 grams (raw weight) of red and processed meat every day for 2 weeks |
| Quorn | Experimental | Other: Quorn240 grams (uncooked weight) of Quorn every day for 2 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male
- 18-50 years.
- Not been diagnosed with colorectal cancer, or adenomas.
- Habitual omnivorous dietary pattern.
- BMI ≥18-30 kg/m2.
Key exclusion criteria (9 listed)
- Been diagnosed with colorectal cancer and/or colorectal adenomas.
- Been diagnosed with gastrointestinal disorders (e.g. Inflammatory bowel disease, irritable bowel syndrome, coeliac disease)
- Adherence to a dietary pattern which excludes foods from an animal origin.
- Abnormal blood biochemistry based on standard clinical cut- offs, as well as blood markers not fitting the inclusion criteria set.
- Have history of food intolerances/allergies (e.g. gluten or dairy) or intolerances (e.g. lactose).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red and Processed MeatIntegration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period. | Other | Red and Processed Meat |
| QuornAlso: Quorn FoodIntegration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period. | Other | Quorn |
Primary outcome
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.
5 secondary outcomes
Oxidative Damage
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Endogenous Short Chain Fatty Acid Production
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Gut Microbial Composition
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Endogenous Production of Para-Cresol
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Changes in MicroRNA Expression
Time frame: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 37624376Farsi DN, Gallegos JL, Finnigan TJA, Cheung W, Munoz JM, Commane DM. The effects of substituting red and processed meat for mycoprotein on biomarkers of cardiovascular risk in healthy volunteers: an analysis of secondary endpoints from Mycomeat. Eur J Nutr. 2023 Dec;62(8):3349-3359. doi: 10.1007/s00394-023-03238-1. Epub 2023 Aug 25.
- Derived from this study: PubMed 36651990Farsi DN, Gallegos JL, Koutsidis G, Nelson A, Finnigan TJA, Cheung W, Munoz-Munoz JL, Commane DM. Substituting meat for mycoprotein reduces genotoxicity and increases the abundance of beneficial microbes in the gut: Mycomeat, a randomised crossover control trial. Eur J Nutr. 2023 Apr;62(3):1479-1492. doi: 10.1007/s00394-023-03088-x. Epub 2023 Jan 18.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
daniel M commane, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red and Processed Meat and Quorn in people with Colorectal Cancer, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03944421, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.