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

NCT ID: NCT03944421

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2020-01-29

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Red and Processed Meat

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

Group Type: EXPERIMENTAL

Red and Processed Meat

Intervention Type: OTHER

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

Quorn

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

Group Type: EXPERIMENTAL

Quorn

Intervention Type: OTHER

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

Interventions

Red and Processed Meat

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

Intervention Type: OTHER

Quorn

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

Intervention Type: OTHER

Other Intervention Names

Quorn Food

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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Quorn

INDUSTRY

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

daniel M commane, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Northumbria University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37624376 (View on PubMed)

Farsi 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.

Reference Type: DERIVED

PMID: 36651990 (View on PubMed)

Other Identifiers

NorthumbriaU001

Identifier Type: -

Identifier Source: org_study_id