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

JRCT ID: jRCTs031220148

Registered date:20/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 10/09/2022
• Target sample size: 24
• Study type: Interventional
• 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.

Outcome(s)

Primary Outcome

Blood:Acetaldehyde concentration,
Blood alcohol concentration
Urine:8OHdG production rate, Isoprostanes production rate, Indoxyl sulfate concentration, Pteridine concentration

• Secondary Outcome: AST, ALT, LDH, GTP, medical questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Male

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Nishizaki Yasuhiro
• Secondary Sponsor: Nihon Trim Co.