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

NCT05673395 | Completed

• 1 other identifier: EMB-2022-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• EARW consumption is effective in reducing oxidative stress

  Reactive oxygen species, nitric oxide, glutathione peroxidase, malondialdehyde

  15 minutes

Secondary Outcomes (1)

• The effects of EARW consumption on exercise-induced fatigue markers in healthy young adults

  15 minutes

Study Arms (2)

EARW group

EXPERIMENTAL

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

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.

Device: Electrolyzed alkaline reduced water generator

Interventions

Electrolyzed alkaline reduced water generator DEVICE

Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.

Also known as: Electrolyzed alkaline ionizer (CGM MWPI-2101

EARW group; PW group

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• any kind of visible or known disease
• hypertension,
• musculoskeletal injuries in the previous three months,
• breathing difficulties,
• metabolic diseases,
• autoimmune disease,
• rash,
• urticaria.

Sponsors & Collaborators

• Kyu Jae Lee: lead
• Ceragem Inc.: collaborator

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Ganwon-do, 26426, South Korea

Location

Study Officials

• Kyu-Jae Lee, Ph.D.

  20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind (participants, investigator)
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 6, 2023
• Study Start: June 13, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)