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出境医 / 临床实验 / The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health (MYCOMEAT)

The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health (MYCOMEAT)

Study Description
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Red and Processed Meat Other: Quorn Not Applicable

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
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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
Arms and Interventions
Arm Intervention/treatment
Experimental: Red and Processed Meat
240 grams (raw weight) of red and processed meat every day for 2 weeks
Other: Red and Processed Meat
Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.

Experimental: Quorn
240 grams (uncooked weight) of Quorn every day for 2 weeks
Other: Quorn
Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.
Other Name: Quorn Food

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Oxidative Damage [ 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.

  2. Endogenous Short Chain Fatty Acid Production [ 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.

  3. Gut Microbial Composition [ 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.

  4. Endogenous Production of Para-Cresol [ 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

  5. Changes in MicroRNA Expression [ 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.


Other Outcome Measures:
  1. Blood Cholesterol [ Time Frame: 2 weeks ]
    Changes in levels of cholesterol in blood samples

  2. Blood Glucose [ Time Frame: 2 weeks ]
    Changes in levels of glucose in blood samples (HbA1c)


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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)
  • Received antibiotics in the previous 6 months.
  • Have participated in similar dietary or prebiotic/probiotics study in the previous 3 months.
  • Current smoker.
Contacts and Locations

Locations
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United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Quorn
Investigators
Layout table for investigator information
Principal Investigator: daniel M commane, PhD Northumbria University
Tracking Information
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
 (submitted: May 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Oxidative Damage [ 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.
  • Endogenous Short Chain Fatty Acid Production [ 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.
  • Gut Microbial Composition [ 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.
  • Endogenous Production of Para-Cresol [ 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
  • Changes in MicroRNA Expression [ 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 7, 2019)
  • Blood Cholesterol [ Time Frame: 2 weeks ]
    Changes in levels of cholesterol in blood samples
  • Blood Glucose [ Time Frame: 2 weeks ]
    Changes in levels of glucose in blood samples (HbA1c)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Other: Red and Processed Meat
    Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.
  • Other: Quorn
    Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.
    Other Name: Quorn Food
Study Arms  ICMJE
  • Experimental: Red and Processed Meat
    240 grams (raw weight) of red and processed meat every day for 2 weeks
    Intervention: Other: Red and Processed Meat
  • Experimental: Quorn
    240 grams (uncooked weight) of Quorn every day for 2 weeks
    Intervention: Other: Quorn
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2019)
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:

  • 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)
  • 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.

Exclusion Criteria:

  • 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)
  • Received antibiotics in the previous 6 months.
  • Have participated in similar dietary or prebiotic/probiotics study in the previous 3 months.
  • Current smoker.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available within 18 months of study completion
Access Criteria: Northumbria University has plans to acquire a data repository for sharing data in the near future.
Responsible Party Northumbria University
Study Sponsor  ICMJE Northumbria University
Collaborators  ICMJE Quorn
Investigators  ICMJE
Principal Investigator: daniel M commane, PhD Northumbria University
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

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