Water Oxygenation and Brain Activity

NYU Langone Health

Status: Completed

Conditions: Muscle Damage

Treatments: Dietary Supplement: Control Unmodified Placebo Water; Dietary Supplement: Electrokinetically modified water (EMW)

Study type: Interventional

Funder types: Other

Identifiers

NCT02688452

15-00230

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Young Healthy Adults

Treatment:

Dietary Supplement: Electrokinetically modified water (EMW)

Dietary Supplement: Electrokinetically modified water (EMW)

Dietary Supplement: Control Unmodified Placebo Water

Group 2

Active Comparator group

Description:

Young Healthy Adults

Treatment:

Dietary Supplement: Electrokinetically modified water (EMW)

Dietary Supplement: Electrokinetically modified water (EMW)

Dietary Supplement: Control Unmodified Placebo Water