Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000033102
• Date of registration: 29/06/2018
• Prospective Registration: No
• Primary sponsor: Huis Ten Bosch Satellite H2 Clinic Hakata Ecomo International Co., Ltd.
• Public title: Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota.
• Scientific title: Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota. - Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota.
• Date of first enrolment: 2016/10/01
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037749
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Toru Ishibashi
• Affiliation: Huis Ten Bosch Satellite H2 Clinic Hakata Department of rheumatology and gastroenterology

• Name: Toru Ishibashi
• Affiliation: Huis Ten Bosch Satellite H2 Clinic Hakata Department of rheumatology and gastroenterology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: All of the subjects took medications or dietary supplements or received medical treatments within 6 months before this study was performed.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

healthy volunteers

Intervention(s)

Daily consumption of the water containing 7ppm molecular hydrogen for 28 days. In detail, the healthy volunteers were informed individually about the significance of the study and the instruments of intended measurement. These volunteers enrolled in this study after providing their written informed consent. The subjects were randomly divided into two groups: a high H2 group and a placebo group. All the subjects were asked to fast, and avoid drinking caffeinated drinks or ingesting sugar for 6 hours before the test. Using the EndPad2000 System (Itamar Medical Inc.), we measured the baseline RHI using endothelium-dependent digital pulse amplitude testing (EndoPAT). Next, the subjects drank 500 ml of the placebo water or the high H2 water (continuing 7ppm H2) within 10 min, and after resting for 1 h the RHI was measured again. On the second day, 24 h after the first ingestion of placebo or high H2 water and before the second ingestion, the RHI was measured. After the measurements were obtained, they took a second drink, and the day after, they drank the placebo or the high H2 water once each day until the day before the last measurements at 14 days. In total, they drank the high H2 water or placebo 14 times.
The placebo water was prepared by filling up a PET bottle containing water with molecular nitrogen (N2) gas under 0.8 MPa to make the placebo bottles as firm as the bottles with the high H2 water containing 7ppm H2.

Primary Outcome(s)

To improve the gut dysbiosis

Source(s) of Monetary Support

None

Secondary Sponsor(s)

Ecomo International Co., Ltd.

Ethics review

Status: YES
Approval date:
Contact: