Hydrate Heroes for Improving Brain Function & Mood

April 29, 2026 updated by: University of South Florida

Boosting Brain and Mood: Exploring the Impact of Hydrate Heroes on Mental Health and Brain Activity

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will utilize electrophysiological measurements of the brain and body.

EEG recordings will be captured using the Emotiv FLEX 2.0 wireless headset, which measures brainwave activity across 32 electrode sites using a standard 10-10 system. EEG data will be collected at 256 Hz and analyzed using EEGLAB software to assess spectral power and topographic changes over time. The protocol includes 20 minutes of EEG testing per session, with specific tasks designed to elicit measurable cognitive responses.

Participants will wear an Empatica Embrace wristband during testing to collect physiological data including motion, stress indicators, and heart rate variability.

Participants will complete a series of validated tests on an iPad while wearing the EEG headset and wrist device. Tasks include:

  • Grandfather Passage (speech task)
  • Card Matching (memory and attention)
  • Boston Naming Test (language)
  • Finger Tapping (motor speed)
  • Trail Making Test (executive function)
  • Dual-Task Performance (cognitive load)

Over 500 digital data features will be captured per session using a system that combines inputs from device sensors (e.g., gyroscope, camera, microphone) with user interactions (e.g., tapping, speech, app use).

Participants will complete standardized questionnaires, including PROMIS-29+2 and IPAQ-SF, to assess aspects such as emotional well-being, physical activity, fatigue, and pain. The PROMIS-29+2 is aA collection of short forms or computer adaptive tests containing a fixed number of items from seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities) The PROMIS-29+2 is used to calculate a preference score. Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Scores can be used in comparisons across groups and for cost-utility analyses. The profile includes all items in the PROMIS-29 Profile v2.1 plus two Cognitive Function Abilities items. T-scores from the measure can be used to calculate a preference-based score.

International Physical Activity Questionnaire (IPAQ) short form is an 8-item questionnaire that encompasses time spent walking, in moderate and vigorous physical activity. The short form is feasible to administer and shows similar reliability and validity results in comparison to the long form. Test-rest reliability indicates good stability and high reliability (α <.80). Scoring provides a categorization of low, moderate, or high intensity of physical activity. Ideally, this will be performed pre- and post-intervention.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nathan D Schilaty, DC, PhD
  • Phone Number: 813-974-1377
  • Email: nschilaty@usf.edu

Study Contact Backup

  • Name: Katherine F Walters, MS
  • Phone Number: 813-974-1377
  • Email: fek@usf.edu

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33620
        • University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Hydrate Heroes A
6 packets / day
Dietary supplement: Hydrate Heroes (6 packets)
Participants that are randomized to the active comparator groups will receive 6 packets of Hydrate Heroes to use daily.
Active Comparator: Hydrate Heroes B
3 packets / day
Dietary supplement: Hydrate Heroes (3 packets)
Participants that are randomized to the active comparator groups will receive 3 packets of Hydrate Heroes to use daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography - Frequencies
Time Frame: 12 weeks

Measurement of brain electrical activity.

Measures will include power band analysis (e.g., delta, theta, alpha, beta, gamma) summed over activities and comparisons made between groups (i.e. ratios).
12 weeks
Electroencephalography - ERP Amplitude
Time Frame: 12 weeks

Measurement of brain electrical activity.

Event-related potentials will be determined from events that occur during the activities. Differences in P300 amplitude will be determined (uV).
12 weeks
Electroencephalograpy - ERP Latency
Time Frame: 12 weeks

Measurement of brain electrical activity.

Event-related potentials will be determined from events that occur during the activities. Differences of P300 latency will be determined between groups (msec).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2
Time Frame: 12 weeks

This single form patient reported outcome provides insight to pain, depression, anxiety, sleep, and physical function.

Score will be reported as a t-score. The average t-score is 50. Deviation from 50 demonstrates magnitude of difference in either positive or negative direction.
12 weeks
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time Frame: 12 weeks
Patient reported outcome of physical activity over a 7-day period. The scores provide both a categorical output of 'Inactive', 'Slightly Active', and 'Active' and a continuous variable of metabolic equivalent (MET).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

July 17, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY008933
  • FHT-25-11 (Other Grant/Funding Number: Florida High-Tech Corridor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hydration Status

Clinical Trials on Hydrate Heroes (6 packets)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe