Colorectal Cancer Clinical Trial
— MYCOMEATOfficial title:
The Effects of Replacing Red and Processed Meat With Quorn on Markers of Gastrointestinal Health
Verified date | May 2019 |
Source | Northumbria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 29, 2020 |
Est. primary completion date | January 29, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northumbria University | Newcastle upon Tyne | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
Northumbria University | Quorn Foods |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood Cholesterol | Changes in levels of cholesterol in blood samples | 2 weeks | |
Other | Blood Glucose | Changes in levels of glucose in blood samples (HbA1c) | 2 weeks | |
Primary | 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 | Oxidative Damage | Changes in the concentration of 8-Hydroxyguanosine levels in urine samples. | 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption | |
Secondary | Endogenous Short Chain Fatty Acid Production | 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. | 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption | |
Secondary | Gut Microbial Composition | Evaluation of post-intervention changes in the composition of the stool microbiota composition from baseline samples. | 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption | |
Secondary | Endogenous Production of Para-Cresol | Change in the concentration of the genotoxic metabolite para-cresol in urine samples | 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption | |
Secondary | Changes in MicroRNA Expression | Evaluation of change in the abundance of microRNAs in plasma separated from blood samples following the intervention. | 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption |
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