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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT02432651
Eligibility Criteria:
Inclusion Criteria:
* Non-smokers or no other tobacco use in the past 3 months.
* Willing to stop taking regular supplements including anti-oxidants for 2 weeks prior to study entry through conclusion of study.
* Willing to stop consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers) for 2 weeks prior to study entry through conclusion of study.
* Must be able to give written informed consent.
* Blood screen tests (Comprehensive metabolic profile \[CMP\] and lipid profile) within normal limits.
Exclusion Criteria:
* Body Mass Index (BMI) less than 18.5 (underweight) or greater than 30 (obese)
* Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease, cancer, history of chemotherapy, celiac disease or gluten/wheat intolerance\*, diabetes, thyroid problems, or any condition which contraindicates, in the investigators judgement, entry into the study.
* Currently taking prescription drugs except oral contraceptives.
* Consumption of more than the recommended alcohol guidelines i.e. \>2 drinks/day.
* Consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers).
* Pregnancy (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study.
* Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis), using UV tanning beds, or unprotected sun exposure greater than 1 hour per day.
* Engaging in vigorous exercise more than 6 hours per week.
* Participation in another dietary study in the past 3 months.
* Had surgery in the last 3 months.
* Post-menopausal status
(\*Note: Beverage is formulated with a barley extract. Barley contains gluten.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02432651
Study Brief:
Protocol Section:
NCT02432651