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Completed

NCT Number: NCT03944421

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

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Red and Processed Meat

Other

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

Quorn

Other

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

Other names: Quorn Food

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Quorn

Registry information

Official study title

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

Acronym: MYCOMEAT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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