Hydration StatusNCT07241260
Hydrate Heroes for Improving Brain Function & Mood
A study testing Hydrate Heroes (6 packets) and Hydrate Heroes (3 packets) in people with Hydration Status, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration Status
- What is being tested?
- Hydrate Heroes (6 packets) and Hydrate Heroes (3 packets)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hydration Status
- Being tested
- Hydrate Heroes (6 packets), Hydrate Heroes (3 packets)
- Keywords
- hydration, electroencephalography, EEG, brain activity, electrolytes, mental health, supplement, depression, anxiety
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (3 packets)Dietary supplement
Participants that are randomized to the active comparator groups will receive 3 packets of Hydrate Heroes to use daily.
| Study group | Role | What they receive |
|---|---|---|
| Hydrate Heroes A | Active comparator | 6 packets / day Receives: Dietary Supplement: Hydrate Heroes (6 packets) |
| Hydrate Heroes B | Active comparator | 3 packets / day Receives: Dietary Supplement: Hydrate Heroes (3 packets) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 12 weeks
Secondary outcomes (2)
Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2
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.
Measured: 12 weeks
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hydration StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241260
- Sponsor's protocol ID
- STUDY008933
- Other IDs
- FHT-25-11
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
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.
PubMed 31103785Palmer JA, Kreutz-Delgado K, Makeig S. AMICA: An Adaptive Mixture of Independent Component Analyzers with Shared Components.
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.
PubMed 40002506Delorme 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.
PubMed 15102499
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Brain and Mood: Exploring the Impact of Hydrate Heroes on Mental Health and Brain Activity
- ClinicalTrials.gov ID
- NCT07241260
- Acronym / sponsor ID
- STUDY008933
- Conditions
- Hydration Status
- Keywords
- hydration, electroencephalography, EEG, brain activity, electrolytes, mental health, supplement, depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrate Heroes A | Active comparator | Dietary Supplement: Hydrate Heroes (6 packets)6 packets / day |
| Hydrate Heroes B | Active comparator | Dietary Supplement: Hydrate Heroes (3 packets)3 packets / day |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (15 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrate Heroes (6 packets)Participants that are randomized to the active comparator groups will receive 6 packets of Hydrate Heroes to use daily. | Dietary supplement | Hydrate Heroes A |
| Hydrate Heroes (3 packets)Participants that are randomized to the active comparator groups will receive 3 packets of Hydrate Heroes to use daily. | Dietary supplement | Hydrate Heroes B |
Primary outcome
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).
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).
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).
2 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2
Time frame: 12 weeks
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- BackgroundMichael 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.
- BackgroundTempleton 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: PubMed 31103785Pion-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.
- BackgroundPalmer JA, Kreutz-Delgado K, Makeig S. AMICA: An Adaptive Mixture of Independent Component Analyzers with Shared Components.
- Background: PubMed 40002506Walters 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.
- Background: PubMed 15102499Delorme 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.
- Hydrate Heroes - Main WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrate Heroes (6 packets) and Hydrate Heroes (3 packets) in people with Hydration Status, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan D Schilaty, DC, PhD (813-974-1377, nschilaty@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography - Frequencies (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07241260, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.