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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT05840627
Eligibility Criteria:
Inclusion Criteria:
* Men or women
* Adults (age ≥ 18 years)
* Filling informed consent
Exclusion Criteria:
* Obesity (body mass index ≥ 30.0 kg/m2).
* Daily consumption of fruit juices in the month prior to the start of the study.
* Individuals with diagnosed food allergies or intolerances to the components being tested.
* Use of pro/prebiotics or fibre as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
* Use of laxatives 6 weeks before recruitment.
* Recent weight loss or weight gain of more than 10% in the last 3 months.
* Adherence to restrictive weight loss diets or specific dietary pattern (e.g., palaeolithic diet, Atkins, flexitarian, ketogenic, vegan).
* Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease, or diabetes mellitus.
* Having taken antibiotics within the 12 weeks prior to beginning the study.
* Excessive consumption of alcoholic beverages (\>14 and \>8 units/week for men and women, respectively).
* Pregnant or breastfeeding.
* Participation in another clinical trial within the past 3 months that the Principal Investigator believes may compromise the results of the trial (e.g., clinical trial with an effect on the composition and diversity of the gut microbiota).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05840627
Study Brief:
Protocol Section:
NCT05840627