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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT07241260
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years at time of consent.
* Fluent in English (able to read, write, speak, and understand English).
* Generally healthy, without chronic medical conditions (see Exclusion 10.3).
* Willing and able to attend three in-person study visits over an approximate 12-week period (enrollment, \~6 weeks, \~12 weeks).
* Willing to consume assigned Hydrate Heroes packets as directed (6 sticks/day, 3 sticks/day, or no supplement for control).
* Willing to log daily water intake and number of Hydrate Heroes packets consumed in the study's online tracking system.
* Capable of providing informed consent.
Exclusion Criteria:
* Neurological or Psychiatric Conditions
* History of epilepsy, recurrent seizures, severe head injury, or other significant neurological disorders.
* Current diagnosis of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe major depressive disorder).
· Cardiovascular or Renal Conditions
* Chronic kidney disease, congestive heart failure, or any condition requiring medically supervised fluid restriction.
* Documented electrolyte imbalance (e.g., hyponatremia, hypokalemia) within the past 6 months.
* Medication and Supplement Conflicts
* Use of medications known to alter EEG readings (e.g., benzodiazepines, antiepileptics, antipsychotics).
* Use of high-dose diuretics or other drugs that substantially affect hydration status.
* Concurrent use of any supplements containing one or more key ingredients of Hydrate Heroes - adaptogenic mushroom blends, magnesium, potassium, zinc, vitamin D₃, vitamin C (including Amla), electrolytes, or elderberry - that cannot be safely discontinued for the 12-week study duration.
* Reproductive Status
* Pregnant or currently breastfeeding.
* Compliance Risk
* Inability or unwillingness to reliably follow the hydration/supplement protocol or complete daily logging.
* Inability to attend scheduled visits or follow instructions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07241260
Study Brief:
Protocol Section:
NCT07241260