Muscle DamageNCT02688452
Water Oxygenation and Brain Activity
A study testing Electrokinetically modified water (EMW) in people with Muscle Damage, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Electrokinetically modified water (EMW)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Water Oxygenation and Brain Activity: A Magnetoencephalographic (MEG) Pilot Study
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
- Being tested
- Control Unmodified Placebo Water, Electrokinetically modified water (EMW)
- Keywords
- strenuous exercise, muscle soreness
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Unmodified Placebo WaterDietary supplement
Electrokinetically modified water (EMW)Dietary supplement
Also called Reliant Recovery Water
Electrokinetically modified water (EMW)Dietary supplement
Control Unmodified Placebo WaterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Young Healthy Adults Receives: Dietary Supplement: Control Unmodified Placebo Water; Dietary Supplement: Electrokinetically modified water (EMW) |
| Group 2 | Active comparator | Young Healthy Adults Receives: Dietary Supplement: Electrokinetically modified water (EMW); Dietary Supplement: Control Unmodified Placebo Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 Week
Secondary outcomes (1)
Self reported changes in behavioral state before and after drinking test product
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodolfo Llinás, MD, PhD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688452
- Sponsor's protocol ID
- 15-00230
- Status last verified
- Jul 2017
- First submitted
- 3 Feb 2016
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Oxygenation and Brain Activity: A Magnetoencephalographic (MEG) Pilot Study
- ClinicalTrials.gov ID
- NCT02688452
- Acronym / sponsor ID
- 15-00230
- Conditions
- Muscle Damage
- Keywords
- strenuous exercise, muscle soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: Control Unmodified Placebo Water, Dietary Supplement: Electrokinetically modified water (EMW)Young Healthy Adults |
| Group 2 | Active comparator | Dietary Supplement: Electrokinetically modified water (EMW), Dietary Supplement: Control Unmodified Placebo WaterYoung Healthy Adults |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Unmodified Placebo Water | Dietary supplement | Group 1 |
| Electrokinetically modified water (EMW)Also: Reliant Recovery Water | Dietary supplement | Group 1 |
| Electrokinetically modified water (EMW) | Dietary supplement | Group 2 |
| Control Unmodified Placebo Water | Dietary supplement | Group 2 |
Primary outcome
Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements
Time frame: 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
Time frame: 1 Week
Magnetic fields will be recorded using a 275-channel whole-head MEG system
1 secondary outcome
Self reported changes in behavioral state before and after drinking test product
Time frame: 1 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolfo Llinás, MD, PhD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrokinetically modified water (EMW) in people with Muscle Damage, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements (time frame: 1 Week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.