Oxidative StressNCT05673395
Drinking Effect of Electrolyzed Alkaline Reduced Water on Oxidative Stress and Fatigue After Intense Exercise
A study testing Electrolyzed alkaline reduced water generator in people with Oxidative Stress, run by Kyu Jae Lee at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to test the drinking effect of electolyzed alkaline reduced water (ARW) generated from alkaline ionizer (CGM MWPI-2101) on oxidative stress and fatigue after high-intensity exercise in healthy people. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Electrolyzed alkaline reduced water generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2022to 30 Jun 2022
- 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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male participants aged 19-25 years
- physically active with a normal body mass index (BMI)
- had not smoked for 3 months or consumed alcohol for more than a week prior to the start of the study.
Who cannot join
- any kind of visible or known disease
- hypertension,
- musculoskeletal injuries in the previous three months,
- breathing difficulties,
- metabolic diseases,
- autoimmune disease,
- rash,
- urticaria.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Ganwon-do, 26426
About this study
Official title: Effects of Alkaline-reduced Water Generated From Electrolyzed Device (CGM MWPI-2101) on High-intensity Exercise-induced Oxidative Stress and Fatigue in Young Male Healthy Adults: Controlled, Randomized, Double-blind Clinical Trial
The goal of this clinical trial is to test the drinking effect of electolyzed alkaline reduced water (ARW) generated from alkaline ionizer (CGM MWPI-2101) on oxidative stress and fatigue after high-intensity exercise in healthy people. The main question[s] it aims to answer are:
- [question 1] Can pH 9.5 EARW reduce oxidative stress compared to purified water (PW)
- [question 2] Can pH 9.5 EARW decrease fatigue markers in blood
Read more
Participants will drink water from the experimental device after high-intensity exercise. Blood sample will be collected before exercise, after highly intensive exercise, and after then 15 min. of drinking water.
Researchers will compare EARW group and PW group to see the anti-oxidative and anti-fatigue effects.
Read the detailed description
This study was designed as a randomized, controlled, crossover, double-blind clinical trial with a single intervention of ARW intake (pH 9.5, 10 mL/kg body weight) after highly intense exercise.
The participants were divided into two groups, wherein they consumed either purified water (PW group) or EARW (EARW group). Blood samples were collected before exercise, immediately after exercise, and 15 min after drinking water.
For the anti-oxidative effect, ROS, NO, GPx, and MDA levels were measured. For the anti-fatigue effect, latate, lactate dehydrogenase, phosphate and calcium were measured.
- Conditions
- Oxidative Stress
- Being tested
- Electrolyzed alkaline reduced water generator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolyzed alkaline reduced water generatorDevice
Also called Electrolyzed alkaline ionizer (CGM MWPI-2101
Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.
| Study group | Role | What they receive |
|---|---|---|
| EARW group | Experimental | This group drink electrolyzed alkaline reduced water (EARW, pH 9.5) 10 mL/kg body weight in 10 min after exercise. Receives: Device: Electrolyzed alkaline reduced water generator |
| PW group | Sham comparator | PW is purified water generated from sham device, and PW group drink 10 mL/kg body weight in 10 min after exercise. Receives: Device: Electrolyzed alkaline reduced water generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
EARW consumption is effective in reducing oxidative stress
Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde
Measured: 15 minutes
Secondary outcomes (1)
The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults
Lactate levels, phosphate levels, cytokines
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start13 Jun 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The participants were randomly divided into two groups (n = 12) according to the sequence of random numbers obtained through an online number generator. After the first clinical trial, A wash-out period of one week was applied to prevent carry-over before crossing over, and the second clinical trial was performed.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyu Jae Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Ceragem Inc.
- Responsible party
- Sponsor-investigator, Kyu Jae Lee, Wonju Severance Christian Hospital
- Investigators
- Kyu-Jae Lee, Ph.D., Study chair, 20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673395
- Sponsor's protocol ID
- EMB-2022-02
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alkaline-reduced Water Generated From Electrolyzed Device (CGM MWPI-2101) on High-intensity Exercise-induced Oxidative Stress and Fatigue in Young Male Healthy Adults: Controlled, Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05673395
- Acronym / sponsor ID
- EMB-2022-02
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kyu Jae LeeUniversity, hospital or other
- Collaborators
- Ceragem Inc.
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Jan 2023 (actual)
- 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 goal of this clinical trial is to test the drinking effect of electolyzed alkaline reduced water (ARW) generated from alkaline ionizer (CGM MWPI-2101) on oxidative stress and fatigue after high-intensity exercise in healthy people. The main question[s] it aims to answer are:
- [question 1] Can pH 9.5 EARW reduce oxidative stress compared to purified water (PW)
- [question 2] Can pH 9.5 EARW decrease fatigue markers in blood
Participants will drink water from the experimental device after high-intensity exercise. Blood sample will be collected before exercise, after highly intensive exercise, and after then 15 min. of drinking water.
Researchers will compare EARW group and PW group to see the anti-oxidative and anti-fatigue effects.
Detailed description
This study was designed as a randomized, controlled, crossover, double-blind clinical trial with a single intervention of ARW intake (pH 9.5, 10 mL/kg body weight) after highly intense exercise.
The participants were divided into two groups, wherein they consumed either purified water (PW group) or EARW (EARW group). Blood samples were collected before exercise, immediately after exercise, and 15 min after drinking water.
For the anti-oxidative effect, ROS, NO, GPx, and MDA levels were measured. For the anti-fatigue effect, latate, lactate dehydrogenase, phosphate and calcium were measured.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The participants were randomly divided into two groups (n = 12) according to the sequence of random numbers obtained through an online number generator. After the first clinical trial, A wash-out period of one week was applied to prevent carry-over before crossing over, and the second clinical trial was performed.
| Arm | Type | Receives |
|---|---|---|
| EARW group | Experimental | Device: Electrolyzed alkaline reduced water generatorThis group drink electrolyzed alkaline reduced water (EARW, pH 9.5) 10 mL/kg body weight in 10 min after exercise. |
| PW group | Sham comparator | Device: Electrolyzed alkaline reduced water generatorPW is purified water generated from sham device, and PW group drink 10 mL/kg body weight in 10 min after exercise. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy male participants aged 19-25 years
- physically active with a normal body mass index (BMI)
- had not smoked for 3 months or consumed alcohol for more than a week prior to the start of the study.
Key exclusion criteria (8 listed)
- any kind of visible or known disease
- hypertension,
- musculoskeletal injuries in the previous three months,
- breathing difficulties,
- metabolic diseases,
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 |
|---|---|---|
| Electrolyzed alkaline reduced water generatorAlso: Electrolyzed alkaline ionizer (CGM MWPI-2101Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise. | Device | EARW group, PW group |
Primary outcome
EARW consumption is effective in reducing oxidative stress
Time frame: 15 minutes
Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde
1 secondary outcome
The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults
Time frame: 15 minutes
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 17 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Kyu-Jae Lee, Ph.D. study chair
20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolyzed alkaline reduced water generator in people with Oxidative Stress, run by Kyu Jae Lee at 1 site in South Korea.
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 3 inclusion and 8 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 17 Jan 2023. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
EARW consumption is effective in reducing oxidative stress (time frame: 15 minutes). 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 17 Jan 2023.