NIPH Clinical Trials Search

JRCT ID: jRCTs031220148

Registered date:20/06/2022

Effects of electrolyzed hydrogen water on ethanol intake mediated generation of acetaldehyde and following organ damages in healthy male volunteers

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedNot applicable
Date of first enrollment10/09/2022
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)After the enrollment, the ALDH2 genotype will be examined two weeks before the start of the study to determine homozygosity and heterozygosity, and the loading test will be conducted in two sessions.


Primary OutcomeBlood:Acetaldehyde concentration, Blood alcohol concentration Urine:8OHdG production rate, Isoprostanes production rate, Indoxyl sulfate concentration, Pteridine concentration
Secondary OutcomeAST, ALT, LDH, GTP, medical questionnaire

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 65age old
Include criteria1.Gender: Male 2.Age: 20 years old or older, under 65 years old 3.Those who enjoy moderate amounts of alcohol in their daily lives and whose weekly alcohol intake is 140g or less.
Exclude criteria1.Those with no drinking habits (less than once a week) 2.Those who have experienced health problems caused by alcohol in the past 3.Those who have started new medications or supplements within the last two months 4.Those suffering from chronic liver diseases (viral, autoimmune, drug-induced, metabolic, etc.) 5.Those taking medications or supplements that affect liver function (ursodeoxycholic acid, glutathione preparations, glycyrrhizin preparations, steroids, anti-hepatitis viruses, propagermanium, koshiba-goto, statins, EPA, DHA, vitamin C, vitamin E, sulforaphane Astaxanthin, liver hydrolysate, turmeric, curcumin, etc.) 6.Those who have ALT 40 IU/L or higher, AST 40 IU/L or higher, GTP 80 IU/L or higher, or total bilirubin 1.5 g/dl or higher 7.Patients with serious heart problems 8.Patients with poor renal function (serum creatinine > 2.0 mg/dL) 9.Those with cancerous conditions 10.Patients with acute or subacute disease at a level above suspicion 11.Those with symptoms such as fever, sore throat, cough, diarrhea, and vomiting 12.Persons who have participated in other human studies within 2 months prior to the start of the study 13.Those who have been drinking hydrogen water continuously before the start of the study. 14.Subjects whose ALDH2 genotype is *2/*2(R) [inactive type 15.Those who don't like shochu 16.Other persons deemed inappropriate by the principal investigator and the investigator in charge of the study

Related Information


Public contact
Name Noriaki Kishimoto
Address 1-2-5 Yoyogi Shibuya-ku Tokyo.Japan Tokyo Japan 151-0053
Telephone +81-3-3370-2321
Affiliation Tokai University Tokyo Hospital
Scientific contact
Name Yasuhiro Nishizaki
Address 1-2-5 Yoyogi Shibuya-ku Tokyo.Japan Tokyo Japan 151-0053
Telephone +81-3-3370-2321
Affiliation Tokai University Tokyo Hospital