Unique ID issued by UMIN | UMIN000018755 |
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Receipt number | R000021174 |
Scientific Title | A clinical study for evaluating the efficacy of the highly-concentrated oxygen nanobubble water -immune function, fatigue, autonomic nervous function and skin function- |
Date of disclosure of the study information | 2016/03/31 |
Last modified on | 2017/02/20 09:12:18 |
A clinical study for evaluating the efficacy of the highly-concentrated oxygen nanobubble water -immune function, fatigue, autonomic nervous function and skin function-
A clinical study for evaluating the efficacy of the highly-concentrated oxygen nanobubble water
A clinical study for evaluating the efficacy of the highly-concentrated oxygen nanobubble water -immune function, fatigue, autonomic nervous function and skin function-
A clinical study for evaluating the efficacy of the highly-concentrated oxygen nanobubble water
Japan |
None
Gastroenterology | Endocrinology and Metabolism | Dermatology |
Adult |
Others
NO
To investigate the effects of the highly-concentrated oxygen nanobubble water on immune function, fatigue, autonomic nervous function and skin function
Efficacy
analysis of the intestinal microflora, NK cell activity, physical performance tests(10-second high power test, physical working capacity test), autonomic nervous system function(spectrum analysis a-a interval of accelerated plethysmography), skin function tests
visual analogue scale(VAS), urinary 8-isoprostane
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Effectiveness of 4-week intake of test food compared with placebo control
Effectiveness of 4-week intake of test food compared with baseline
30 | years-old | <= |
60 | years-old | >= |
Male and Female
The subject who meets all the conditions in a screening test
1)Healthy males and females aged from 30 to 60 years (bounds included)
2) Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
1) Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subject having the chronic fatigue syndrome(CFS) , or subject deemed to have severe fatigue like idiopathic chronic fatigue by the investigator
3) Subject having a medical history of chest pain or syncope
4) Subject having an abnormality in the electrocardiogram
5)Subject having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations
6)Subjects who take regularly medical supplies or quasi-drugs which having the efficacy on recovery of fatigue or nutrition disorder at physical fatigue
7) Subjects who take regularly the highly-concentrated oxygen water
8) Subject having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
9)Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
10)Female subjects who is pregnant or lactating, or intending to become pregnant during the study
11)Subject deemed unsuitable by the investigator
17
1st name | |
Middle name | |
Last name | Osami Kajimoto |
Osaka City University Graduate School of Medicine
Department of Medical Science on Fatigue
1-4-3 Asahi-machi, Abeno-ku, Osaka
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Tomohiro Sugino |
Soiken Inc.
R&D Division
Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc.
Nikken Lease Kogyo Co.,Ltd.
Profit organization
NO
2016 | Year | 03 | Month | 31 | Day |
Unpublished
Completed
2015 | Year | 06 | Month | 20 | Day |
2015 | Year | 08 | Month | 22 | Day |
2015 | Year | 08 | Month | 21 | Day |
2017 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021174
Research Plan | |
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