Boosting Brain and Mood: Exploring the Impact of Hydrate Heroes on Mental Health and Brain Activity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Electroencephalography - Frequencies
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hydrate Heroes A
6 packets / day
干预措施: Hydrate Heroes (6 packets) (Dietary Supplement)
Hydrate Heroes B
3 packets / day
干预措施: Hydrate Heroes (3 packets) (Dietary Supplement)
Control
结局指标
主要结局
Electroencephalography - Frequencies
时间窗: 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).
Electroencephalograpy - ERP Latency
时间窗: 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).
Electroencephalography - ERP Amplitude
时间窗: 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).
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS)-29 + 2(12 weeks)
- International Physical Activity Questionnaire - Short Form (IPAQ-SF)(12 weeks)