Drinking Effect of Electrolyzed Alkaline Reduced Water on Oxidative Stress and Fatigue After Intense Exercise

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

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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress
• Intervention / Treatment: Device: Electrolyzed alkaline reduced water generator

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ganwon-do
    • Wonju, Ganwon-do, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EARW group; This group drink electrolyzed alkaline reduced water (EARW, pH 9.5) 10 mL/kg body weight in 10 min after exercise.	Device: Electrolyzed alkaline reduced water generator; Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.; Other Names: Electrolyzed alkaline ionizer (CGM MWPI-2101
Sham Comparator: PW group; PW is purified water generated from sham device, and PW group drink 10 mL/kg body weight in 10 min after exercise.	Device: Electrolyzed alkaline reduced water generator; Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.; Other Names: Electrolyzed alkaline ionizer (CGM MWPI-2101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EARW consumption is effective in reducing oxidative stress	Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults	Lactate levels, phosphate levels, cytokines	15 minutes

Collaborators and Investigators

• Sponsor: Kyu Jae Lee
• Collaborators: Ceragem Inc.
• Investigators: Study Chair: Kyu-Jae Lee, Ph.D., 20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 31, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: EMB-2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No