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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03944421

Recruitment Status Completed

First Posted May 9, 2019

Last update posted June 1, 2020

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:Colorectal Cancer
  • Intervention/Treatment: Other: Red and Processed Meat
    Other: Quorn
  • Phase: 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: July 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: January 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.
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 [ 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 Outcome Measures: 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 Outcome Measures: 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)
Eligibility Criteria
  • Ages Eligible for Study: 18 to 50 Years (Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: Yes
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.

Contacts and Locations
Contacts
Locations

United Kingdom, Tyne And Wear
Northumbria University
Newcastle upon Tyne

Sponsors and Collaborators

Northumbria University

Quorn Foods

Investigators

Principal Investigator: daniel M commane, PhD Northumbria University

More Information
  • Responsible Party: Northumbria University
  • ClinicalTrials.gov Identifier: NCT03944421 History of Changes
  • Other Study ID Numbers: NorthumbriaU001
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: June 1, 2020
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
  • Supporting Materials: Study Protocol, Informed Consent Form (ICF), Clinical Study Report (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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Northumbria University: Genotoxicity
    DNA damage
    Gut Microbiota
    Metabolites
  • Additional relevant MeSH terms: Colorectal Neoplasms