Water Oxygenation and Brain Activity

NCT ID: NCT02688452

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-07-01

Brief Summary

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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).

Detailed Description

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Conditions

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Muscle Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Young Healthy Adults

Group Type ACTIVE_COMPARATOR

Control Unmodified Placebo Water

Intervention Type DIETARY_SUPPLEMENT

Electrokinetically modified water (EMW)

Intervention Type DIETARY_SUPPLEMENT

Group 2

Young Healthy Adults

Group Type ACTIVE_COMPARATOR

Electrokinetically modified water (EMW)

Intervention Type DIETARY_SUPPLEMENT

Control Unmodified Placebo Water

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Control Unmodified Placebo Water

Intervention Type DIETARY_SUPPLEMENT

Electrokinetically modified water (EMW)

Intervention Type DIETARY_SUPPLEMENT

Electrokinetically modified water (EMW)

Intervention Type DIETARY_SUPPLEMENT

Control Unmodified Placebo Water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Reliant Recovery Water

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodolfo LlinĂ¡s, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-00230

Identifier Type: -

Identifier Source: org_study_id

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