Hydrate Heroes for Improving Brain Function & Mood

Sponsored by University of South Florida

About this trial

Last updated 6 months ago

Study ID

STUDY008933

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Started 5 months ago

What is this trial about?

The primary goal of this 12-week randomized controlled study is to evaluate whether daily use of Hydrate Heroes results in measurable improvements in brain activity, mental health, and performance on cognitive tasks. By analyzing brainwave data, physical response metrics, and patient-reported outcomes, the study will demonstrate whether the supplement produces meaningful effects on mental and neurological health.

What are the participation requirements?

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.