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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Participants that are randomized to the active comparator groups will receive 6 packets of Hydrate Heroes to use daily.
Participants that are randomized to the active comparator groups will receive 3 packets of Hydrate Heroes to use daily.
University of South Florida
Tampa, Florida, United States
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).
Time frame: 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).
Time frame: 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).
Time frame: 12 weeks
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.
Time frame: 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).
Time frame: 12 weeks
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