Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT06459661
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-60 years.
* Healthy as determined from self-reported medical history or when no relevant medical condition exists.
* Stool frequency of 3 to 21 times per week.
* Able to attend a session in person at City Campus or Headingley Campus, Leeds Beckett University, or City Campus, Sheffield Hallam University.
* For women: Use of contraceptive methods or not planning to become pregnant for the duration of the study.
* Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements.
Exclusion Criteria:
* Food allergy or intolerance
* Currently dieting to lose weight
* For women: Pregnancy, lactation
* Bowel disease
* Use of medicine causing constipation
* Abnormal gastro-intestinal (gut) function or structure such as malformation, angiodysplasia or active peptic ulcer
* History of gastro-intestinal surgery with permanent effect (e.g., surgical treatment of obesity)
* Active inflammatory bowel disease, coeliac disease, chronic pancreatitis, or other disorder potentially causing malabsorption
* Currently experiencing or been diagnosed with gastro-intestinal symptoms (e.g., abdominal pain/cramps, heartburn, stomach acid/reflux, nausea, vomiting, abdominal rumbling, bloating, belching, excess gas/wind)
* Active constipation (i.e., currently constipated).
* Active Irritable Bowel Syndrome
* Currently experiencing disordered eating
* Current use of laxatives
* Current use or within the previous 3 months use of prescription or over-the-counter medication that has the potential of affecting gut bacteria including food supplements (specific medications will be assessed on an individual basis).
* Use of antibiotics or pain medication containing opiates or morphine currently or within the previous 3 months.
* Use of opioid drugs of abuse (e.g., heroin, fentanyl) currently or within the previous 3 months.
* Consumption of more than 21 units of alcohol per week (men)/ more than 14 unit of alcohol per week (women).
* Malignancy/cancer which is currently active or in remission for less than 2 years after treatment.
* Currently experiencing a psychiatric disorder or a condition related with your mental health that impacts on your daily life (e.g., major depression, bipolar disorders).
* Currently engaging in intense physical activity more than 3 times per week (assessed on an individual basis).
* Presenting a psychological or linguistic incapability to sign the informed consent/ Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.
* Parallel participation in another research project which involves dietary intervention/other clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06459661
Study Brief:
Protocol Section:
NCT06459661