Unique ID issued by UMIN | UMIN000033102 |
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Receipt number | R000037749 |
Scientific Title | Double blinded and placebo controlled examination to observe the effects of the water containing 7ppm molecular hydrogen on the gut microbiota. |
Date of disclosure of the study information | 2018/06/29 |
Last modified on | 2018/06/25 12:19:47 |
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.
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.
Japan |
healthy volunteers
Gastroenterology | Clinical immunology | Adult |
Others
NO
To improve the gut dysbiosis
Efficacy
To improve the gut dysbiosis
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
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.
20 | years-old | <= |
Not applicable |
Male and Female
Healthy volunteers
All of the subjects took medications or dietary supplements or received medical treatments within 6 months before this study was performed.
50
1st name | |
Middle name | |
Last name | Toru Ishibashi |
Huis Ten Bosch Satellite H2 Clinic Hakata
Department of rheumatology and gastroenterology
2-1 Gion, Hakata-ku, Fukuoka 812-0038, Japan
+81-92-282-5005
tishibashi@h2-lab.jp
1st name | |
Middle name | |
Last name | Toru Ishibashi |
Huis Ten Bosch Satellite H2 Clinic Hakata
Department of rheumatology and gastroenterology
2-1 Gion, Hakata-ku, Fukuoka 812-0038, Japan
+81-92-282-5005
info@h2-clinic.jp
Huis Ten Bosch Satellite H2 Clinic Hakata
Ecomo International Co., Ltd.
None
Self funding
Ecomo International Co., Ltd.
NO
2018 | Year | 06 | Month | 29 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 10 | Month | 01 | Day |
2018 | Year | 06 | Month | 22 | Day |
2018 | Year | 06 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037749
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