NCT07241260

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

July 17, 2025

Last Update Submit

April 29, 2026

Conditions

Hydration Status

Keywords

hydrationelectroencephalographyEEGbrain activityelectrolytesmental healthsupplementdepressionanxiety

Outcome Measures

Primary Outcomes (3)

  • Electroencephalography - Frequencies

    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

    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

    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 Outcomes (2)

  • Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2

    12 weeks

  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    12 weeks

Study Arms (3)

Hydrate Heroes A

ACTIVE COMPARATOR

6 packets / day

Dietary Supplement: Hydrate Heroes (6 packets)

Hydrate Heroes B

ACTIVE COMPARATOR

3 packets / day

Dietary Supplement: Hydrate Heroes (3 packets)

Control

NO INTERVENTION

Interventions

Hydrate Heroes (6 packets)DIETARY_SUPPLEMENT

Participants that are randomized to the active comparator groups will receive 6 packets of Hydrate Heroes to use daily.

Hydrate Heroes A
Hydrate Heroes (3 packets)DIETARY_SUPPLEMENT

Participants that are randomized to the active comparator groups will receive 3 packets of Hydrate Heroes to use daily.

Hydrate Heroes B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years at time of consent.
  • Fluent in English (able to read, write, speak, and understand English).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

Related Publications (6)

  • Michael J, John T, Templeton M. Towards a Comprehensive Mobile-Based Neurocognitive Digital Health Assessment System (NDHAS) Towards a Comprehensive Mobile-Based Neurocognitive Digital Health Assessment System (NDHAS) Templeton. J M. Published online 2022.

    BACKGROUND

  • Templeton JM, Poellabauer C, Schneider S. Design of a neurocognitive digital health system (NDHS) for neurodegenerative diseases. In: Proceedings of the 2021 Workshop on Future of Digital Biomarkers. ACM; 2021:26-33.

    BACKGROUND

  • Pion-Tonachini L, Kreutz-Delgado K, Makeig S. ICLabel: An automated electroencephalographic independent component classifier, dataset, and website. Neuroimage. 2019 Sep;198:181-197. doi: 10.1016/j.neuroimage.2019.05.026. Epub 2019 May 16.

    PMID: 31103785BACKGROUND

  • Palmer JA, Kreutz-Delgado K, Makeig S. AMICA: An Adaptive Mixture of Independent Component Analyzers with Shared Components.

    BACKGROUND

  • Walters KF, Shukla R, Kumar V, Schueren S, Yadav H, Schilaty ND, Jain S. Resting-State EEG Power Spectral Density Analysis Between Healthy and Cognitively Impaired Subjects. Brain Sci. 2025 Feb 10;15(2):173. doi: 10.3390/brainsci15020173.

    PMID: 40002506BACKGROUND

  • Delorme A, Makeig S. EEGLAB: an open source toolbox for analysis of single-trial EEG dynamics including independent component analysis. J Neurosci Methods. 2004 Mar 15;134(1):9-21. doi: 10.1016/j.jneumeth.2003.10.009.

    PMID: 15102499BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-BeingDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsMental Disorders

Central Study Contacts

Nathan D Schilaty, DC, PhD

CONTACT

813-974-1377nschilaty@usf.edu

Katherine F Walters, MS

CONTACT

813-974-1377fek@usf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2025

First Posted

November 21, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)