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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Red and Processed Meat

Quorn

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring Genotoxicity, DNA damage, Gut Microbiota, Metabolites

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Red and Processed Meat

Quorn

Arm Description

240 grams (raw weight) of red and processed meat every day for 2 weeks

240 grams (uncooked weight) of Quorn every day for 2 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Oxidative Damage

Changes in the concentration of 8-Hydroxyguanosine levels in urine samples.

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.

Gut Microbial Composition

Evaluation of post-intervention changes in the composition of the stool microbiota composition from baseline samples.

Endogenous Production of Para-Cresol

Change in the concentration of the genotoxic metabolite para-cresol in urine samples

Changes in MicroRNA Expression

Evaluation of change in the abundance of microRNAs in plasma separated from blood samples following the intervention.

Full Information

NCT ID

NCT03944421

First Posted

March 5, 2019

Last Updated

May 28, 2020

Sponsor

Northumbria University

Collaborators

Quorn

1. Study Identification

Unique Protocol Identification Number

NCT03944421

Brief Title

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

Acronym

MYCOMEAT

Official Title

The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

July 3, 2019 (Actual)

Primary Completion Date

January 29, 2020 (Actual)

Study Completion Date

January 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northumbria University

Collaborators

Quorn

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Genotoxicity, DNA damage, Gut Microbiota, Metabolites

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Red and Processed Meat

Arm Type

Experimental

Arm Description

240 grams (raw weight) of red and processed meat every day for 2 weeks

Arm Title

Quorn

Arm Type

Experimental

Arm Description

240 grams (uncooked weight) of Quorn every day for 2 weeks

Intervention Type

Other

Intervention Name(s)

Red and Processed Meat

Intervention Description

Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.

Intervention Type

Other

Intervention Name(s)

Quorn

Other Intervention Name(s)

Quorn Food

Intervention Description

Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.

Primary Outcome Measure Information:

Title

Genotoxic potential of Faecal extracts from volunteers consuming intervention diets rich in red and processed meat versus diets containing Quorn

Description

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

Secondary Outcome Measure Information:

Title

Oxidative Damage

Description

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

Title

Endogenous Short Chain Fatty Acid Production

Description

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

Title

Gut Microbial Composition

Description

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

Title

Endogenous Production of Para-Cresol

Description

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

Title

Changes in MicroRNA Expression

Description

Evaluation of change in the abundance of microRNAs in plasma separated from blood samples following the intervention.

Time Frame

2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption

Other Pre-specified Outcome Measures:

Title

Blood Cholesterol

Description

Changes in levels of cholesterol in blood samples

Time Frame

2 weeks

Title

Blood Glucose

Description

Changes in levels of glucose in blood samples (HbA1c)

Time Frame

2 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

daniel M commane, PhD

Organizational Affiliation

Northumbria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northumbria University

City

Newcastle upon Tyne

State/Province

Tyne And Wear

ZIP/Postal Code

NE1 8ST

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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