Hydrate Heroes for Improving Brain Function & Mood

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Hydrate Heroes (6 packets)
  Participants that are randomized to the active comparator groups will receive 6 packets of Hydrate Heroes to use daily.
• Пищевая добавка Hydrate Heroes (3 packets)
  Participants that are randomized to the active comparator groups will receive 3 packets of Hydrate Heroes to use daily.

Первичные конечные точки

• Electroencephalography - Frequencies [Срок оценки: 12 weeks]
• Electroencephalography - ERP Amplitude [Срок оценки: 12 weeks]
• Electroencephalograpy - ERP Latency [Срок оценки: 12 weeks]

Вторичные конечные точки (2)

• Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2 [Срок оценки: 12 weeks]
• International Physical Activity Questionnaire - Short Form (IPAQ-SF) [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of South Florida — Tampa

Публикации

• 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. PMID 31103785
• Palmer 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. PMID 40002506
• 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 15102499

Идентификаторы

NCT: NCT07241260 · STUDY008933 · FHT-25-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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