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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05673395
Other study ID # EMB-2022-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 13, 2022
Est. completion date June 30, 2022

Study information

Verified date January 2023
Source Wonju Severance Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 25 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - any kind of visible or known disease - hypertension, - musculoskeletal injuries in the previous three months, - breathing dif?culties, - metabolic diseases, - autoimmune disease, - rash, - urticaria.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electrolyzed alkaline reduced water generator
Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.

Locations

Country Name City State
Korea, Republic of Wonju Severance Christian Hospital Wonju Ganwon-do

Sponsors (2)

Lead Sponsor Collaborator
Kyu Jae Lee Ceragem Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary EARW consumption is effective in reducing oxidative stress Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde 15 minutes
Secondary The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults Lactate levels, phosphate levels, cytokines 15 minutes
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