Water Oxygenation and Brain Activity: A Magnetoencephalographic (MEG) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements
研究概览
简要总结
The primary purpose of this interventional, placebo controlled, crossover, double blind, basic science exploratory study is to investigate whether there is a difference in brain electrophysiological oscillatory activity in healthy adults before and after oral consumption of water containing very small bubbles of oxygen (electrokinetically modified water).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of any ethnic background;
- •living in New York tri-state area;
- •fluent in English;
- •normal or corrected to normal vision and hearing;
- •willing to complete all study procedures; and
- •capable of giving written informed consent.
排除标准
- •A history of gross brain abnormalities such as stroke, severe ventriculomegaly or severe periventricular white matter abnormalities;
- •a history of serious psychiatric or neurological disorders, including psychosis or major depression, alcohol or drug abuse, brain injury, seizure disorder, brain tumor, etc.;
- •taking psychoactive medications, including antipsychotics, anxiolytics and antidepressants, or cognitive enhancers such as cholinesterase inhibitors;
- •presence of contraindications for MEG or MRI recording, including any of the following: cardiac pacemaker, intracranial clips, metal implants, or external clips within 10 mm of the head, metal in eyes, claustrophobia, obesity and/or any other reason leading to difficulty staying in the MEG or MRI for up to one hour.
研究组 & 干预措施
Group 1
Young Healthy Adults
干预措施: Control Unmodified Placebo Water (Dietary Supplement)
Group 1
Young Healthy Adults
干预措施: Electrokinetically modified water (EMW) (Dietary Supplement)
Group 2
Young Healthy Adults
干预措施: Electrokinetically modified water (EMW) (Dietary Supplement)
Group 2
Young Healthy Adults
干预措施: Control Unmodified Placebo Water (Dietary Supplement)
结局指标
主要结局
Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements
时间窗: 1 Week
Magnetic fields will be recorded using a 275-channel whole-head MEG system
Changes in localization of spontaneous brain activity measured before and after drinking the test products using Magnetoencephalography (MEG) measurements
时间窗: 1 Week
Magnetic fields will be recorded using a 275-channel whole-head MEG system
次要结局
- Self reported changes in behavioral state before and after drinking test product(1 Week)