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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT04265300
Eligibility Criteria:
Inclusion Criteria:
* males and females
* aged 7-12 years old
* Guardians must also meet the criteria which is that
* 1\) they shop at Whole Foods, Costco, or Trader Joe's
* 2\) they use organic ingredients \&
* 3\) they check the nutritional content on foods for their children.
Exclusion Criteria:
* prior diagnosis of cognitive or learning disabilities
* history of chronic kidney disease,
* diabetes
* sleep disorders
* use of medications that may alter water balance (e.g. diuretics, laxatives, antacids, anti-histamines, NSAIDs, blood pressure medication)
* mood and anxiety medications (e.g. antidepressants, anxiolytics, beta-blockers, ADHD medications).
* Other medications that can cause urine color changes include isoniazid, sulfasalazine, metronidazole, nitrofurantoin, amitriptyline, cimetidine, indomethacin, zaleplon, methocarbamol, metoclopramide, warfarin, rifampin, and phenazopyridine
* Participants who do not like the Creative Roots beverage
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT04265300
Study Brief:
Protocol Section:
NCT04265300