Drinking Effect of Electrolyzed Alkaline Reduced Water on... | NCT05673395

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

NCT05673395

Sponsor

Kyu Jae Lee

Status

Completed

Last Update Posted

Jan 17, 2023Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Oxidative Stress

Interventions

Electrolyzed alkaline reduced water generator

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2022Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Dec 19, 2022

First Submission Date that Met QC Criteria

Dec 31, 2022

First Posted Date

Jan 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2023

Last Update Posted Date

Jan 17, 2023Actual

Name	Class
Ceragem Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Electrolyzed alkaline reduced water generator	Device	Participants drink water (10 mL/kg body weight) generated from the device after intensive excercise.	EARW group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyu-Jae Lee, Ph.D.	20, Ilsan-dong, Wonju, Gangwon-do, South Korea, 26426	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wonju Severance Christian Hospital		Wŏnju	Ganwon-do	26426	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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.