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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT05146804
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form (ICF) prior to initiation of any study related procedures
* Male or female volunteer
* Age 18-50 years
* BMI between 18.5-30 kg/m2
* Stable weight and no intention to lose weight until completion of the study; no reported weight loss or weight gain of ≥ 5 kg 3 months prior to inclusion into this study
* Constant eating habits during at least 3 months prior to inclusion into the study
Exclusion Criteria:
* Having a history of medical or surgical events that may significantly affect the study outcomes and inflammatory response. More specifically, the previous diagnosis of an inflammatory condition or disease or a history of hypothyroidism, chronic kidney or/and liver disorders, coronary artery disease, malignant hypertension, seizures.
* Involved in intensive sports activities more than 4 times a week or at top sport level (e.g. playing football, tennis, running, race-cycling, swimming)
* Regular intake of medication. More specific, medication that may affect inflammatory response including NSAIDs such as Ibuprofen, Naproxen, Diclofenac is not allowed from 2 weeks before screening until the end of the study. Participants are allowed to use oral contraceptives before and during the study.
* Psychotic, addictive or other mental disorders limiting the ability to provide informed consent or to comply with the study requirements
* Aversion, intolerance or allergy to cruciferous vegetables (e.g. kale consumption; bloating) or ingredients of the PhenFlex drink (palm olein, dextrose, protein supplement, vanilla aroma).
* Use of dietary supplements with potential effects on antioxidant or inflammatory status within 4 weeks prior to inclusion into this study. Examples of dietary supplements not allowed in the study include supplements containing flavonoids, glucosinolates, carotenoids, ergothioneine, polyacetylenes and polysaccharides. - Excessive alcohol consumption (≥ 28 consumptions approx. 250 g alcohol per week)
* Viral or bacterial infection requiring use of antibiotics, laxatives and anti-diarrheal drugs within 4 weeks prior to inclusion into this study
* Pregnancy and/or breastfeeding
* Reported slimming or medically prescribed diet
* Vegetarian or vegan lifestyle
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05146804
Study Brief:
Protocol Section:
NCT05146804