The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health (NCT03944421) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health
United Kingdom20 participantsStarted 2019-07-03
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/allergi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Genotoxic potential of Faecal extracts from volunteers consuming intervention diets rich in red and processed meat versus diets containing Quorn
Timeframe: 2 weeks- Change from baseline following two week intervention with meat versus Quorn consumption