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

Primary Purpose

Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electrolyzed alkaline reduced water generator
Sponsored by
Kyu Jae Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Oxidative Stress

Eligibility Criteria

19 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

EARW group

PW group

Arm Description

This group drink electrolyzed alkaline reduced water (EARW, pH 9.5) 10 mL/kg body weight in 10 min after exercise.

PW is purified water generated from sham device, and PW group drink 10 mL/kg body weight in 10 min after exercise.

Outcomes

Primary Outcome Measures

EARW consumption is effective in reducing oxidative stress
Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde

Secondary Outcome Measures

The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults
Lactate levels, phosphate levels, cytokines

Full Information

First Posted
December 19, 2022
Last Updated
January 13, 2023
Sponsor
Kyu Jae Lee
Collaborators
Ceragem Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05673395
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kyu Jae Lee
Collaborators
Ceragem Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
double blind (participants, investigator)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EARW group
Arm Type
Experimental
Arm Description
This group drink electrolyzed alkaline reduced water (EARW, pH 9.5) 10 mL/kg body weight in 10 min after exercise.
Arm Title
PW group
Arm Type
Sham Comparator
Arm Description
PW is purified water generated from sham device, and PW group drink 10 mL/kg body weight in 10 min after exercise.
Intervention Type
Device
Intervention Name(s)
Electrolyzed alkaline reduced water generator
Other Intervention Name(s)
Electrolyzed alkaline ionizer (CGM MWPI-2101
Intervention Description
Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.
Primary Outcome Measure Information:
Title
EARW consumption is effective in reducing oxidative stress
Description
Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults
Description
Lactate levels, phosphate levels, cytokines
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Jae Lee, Ph.D.
Organizational Affiliation
20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426
Official's Role
Study Chair
Facility Information:
Facility Name
Wonju Severance Christian Hospital
City
Wonju
State/Province
Ganwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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