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

NCT03944421 | Completed

• 1 other identifier: NorthumbriaU001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Genotoxicity; DNA damage; Gut Microbiota; Metabolites

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Oxidative Damage

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

• Endogenous Short Chain Fatty Acid Production

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

• Gut Microbial Composition

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

• Endogenous Production of Para-Cresol

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

• Changes in MicroRNA Expression

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

Other Outcomes (2)

• Blood Cholesterol

  2 weeks

• Blood Glucose

  2 weeks

Study Arms (2)

Red and Processed Meat

EXPERIMENTAL

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

Other: Red and Processed Meat

Quorn

EXPERIMENTAL

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

Other: Quorn

Interventions

Red and Processed Meat OTHER

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

Red and Processed Meat

Quorn OTHER

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

Also known as: Quorn Food

Quorn

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Northumbria University: lead
• Quorn: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37624376 DERIVED

• 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.

  PMID: 36651990 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Dyrk Kinases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Protein-Tyrosine Kinases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• daniel M commane, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: May 9, 2019
• Study Start: July 3, 2019
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: June 1, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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.

Locations

GB (1)