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 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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Red and Processed Meat; Other: 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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 8ST
      • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Quorn Food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative Damage	Changes in the concentration of 8-Hydroxyguanosine levels in urine samples.	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.	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.	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	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.	2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Cholesterol	Changes in levels of cholesterol in blood samples	2 weeks
Blood Glucose	Changes in levels of glucose in blood samples (HbA1c)	2 weeks

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Quorn
• Investigators: Principal Investigator: daniel M commane, PhD, Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): January 29, 2020
• Study Completion (Actual): January 29, 2020

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: DNA damage; Gut Microbiota; Metabolites; Genotoxicity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NorthumbriaU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 18 months of study completion
• IPD Sharing Access Criteria: Northumbria University has plans to acquire a data repository for sharing data in the near future.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No