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

Not Applicable

• Conditions: ot applicable

• Registration Number: JPRN-jRCTs031220148
• Lead Sponsor: ishizaki Yasuhiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-20
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1.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.

Exclusion Criteria

1.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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood:Acetaldehyde concentration,<br>Blood alcohol concentration<br>Urine:8OHdG production rate, Isoprostanes production rate, Indoxyl sulfate concentration, Pteridine concentration

Secondary Outcome Measures

Name	Time	Method
AST, ALT, LDH, GTP, medical questionnaire