Clinical trial NCT05673395: Drinking Effect of Electrolyzed Alkaline Reduced Water on Oxidative Stress and Fatigue After Intense Exercise
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
Collaborators: name: Ceragem Inc.
First posted: 2023-01-06
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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 difﬁculties,
* metabolic diseases,
* autoimmune disease,
* rash,
* urticaria.

Primary outcomes:
measure: EARW consumption is effective in reducing oxidative stress
timeFrame: 15 minutes
Secondary outcomes:
measure: The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Ganwon-do
Study officials:
affiliation: 20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
name: Kyu-Jae Lee, Ph.D.
role: STUDY_CHAIR
References: