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

Sponsor
Northumbria University (Other)
Overall Status
Completed
CT.gov ID
NCT03944421
Collaborator
Quorn (Industry)
20
1
2
6.9
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Red and Processed Meat
  • Other: Quorn
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health
Actual Study Start Date :
Jul 3, 2019
Actual Primary Completion Date :
Jan 29, 2020
Actual Study Completion Date :
Jan 29, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Genotoxic potential of Faecal extracts from volunteers consuming intervention diets rich in red and processed meat versus diets containing Quorn [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 Outcome Measures

    1. Oxidative Damage [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 [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 [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 [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 [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 Outcome Measures

    1. Blood Cholesterol [2 weeks]

      Changes in levels of cholesterol in blood samples

    2. Blood Glucose [2 weeks]

      Changes in levels of glucose in blood samples (HbA1c)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northumbria University Newcastle upon Tyne Tyne And Wear United Kingdom NE1 8ST

    Sponsors and Collaborators

    • Northumbria University
    • Quorn

    Investigators

    • Principal Investigator: daniel M commane, PhD, Northumbria University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northumbria University
    ClinicalTrials.gov Identifier:
    NCT03944421
    Other Study ID Numbers:
    • NorthumbriaU001
    First Posted:
    May 9, 2019
    Last Update Posted:
    Jun 1, 2020
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Northumbria University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2020