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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT05367804
Eligibility Criteria:
Inclusion Criteria:
* Age 18-45 years
* Body mass index (BMI) 18,5-30 kg/m2
* Weight stable within the previous 3 months
* Maintenance of the usual physical activity habits during the study
* Intake of fibre between 15 and 25 g per day (evaluated by 3 food diaries or 24-hours recalls)
* Omnivores
Exclusion Criteria:
* Acute chronic disease, inflammatory or functional gastrointestinal diseases and any other disease or disorder that could affect the outcome of the study
* Use of a medication that may interfere the study outcome
* Eating disorder
* High protein intake (more than 15% of energy or maximum 1,2 g of protein per kg of body weight per day; evaluated by 3 food diaries or 24-hours recalls)
* Use of antibiotic medication during the last 3 months prior the first visit
* Use of antibiotic medication very early in life (e.g., asthmatic children or ear inflammation)
* Use of laxative or anti-diarrhoea medication within the past 3 months before the study
* Regular consumption of probiotic or prebiotic product for the past 6 weeks before the study
* Special diet that is considered to affect the study participation and/or study results, for example, high protein diets
* More than 5 h of moderate-vigorous exercise per week
* Pregnancy or breastfeeding
* Intolerance to dietary supplements that will be used in the study
* Smoking
* Abuse of alcohol or drugs (according to AUDIT score)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05367804
Study Brief:
Protocol Section:
NCT05367804