Water Oxygenation and Brain Activity

NCT02688452 | Completed

• 1 other identifier: 15-00230
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Muscle Damage

Keywords

strenuous exercise; muscle soreness

Outcome Measures

Primary Outcomes (2)

• Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements

  Magnetic fields will be recorded using a 275-channel whole-head MEG system

  1 Week

• Changes in localization of spontaneous brain activity measured before and after drinking the test products using Magnetoencephalography (MEG) measurements

  Magnetic fields will be recorded using a 275-channel whole-head MEG system

  1 Week

Secondary Outcomes (1)

• Self reported changes in behavioral state before and after drinking test product

  1 Week

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Young Healthy Adults

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

Group 2

ACTIVE COMPARATOR

Young Healthy Adults

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

Interventions

Control Unmodified Placebo Water DIETARY_SUPPLEMENT

Group 1

Electrokinetically modified water (EMW) DIETARY_SUPPLEMENT

Also known as: Reliant Recovery Water

Group 1

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodolfo Llinás, MD, PhD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 23, 2016
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

US (1)