UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the efficacy of the highly-concentrated oxygen nanobubble water -immune function, fatigue, autonomic nervous function and skin function-
Title of the study (Brief title)	A clinical study for evaluating the efficacy of the highly-concentrated oxygen nanobubble water
Region	Japan

Condition
Condition	None
Classification by specialty	Gastroenterology Endocrinology and Metabolism Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of the highly-concentrated oxygen nanobubble water on immune function, fatigue, autonomic nervous function and skin function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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
Key secondary outcomes	visual analogue scale(VAS), urinary 8-isoprostane

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Effectiveness of 4-week intake of test food compared with placebo control
Interventions/Control_2	Effectiveness of 4-week intake of test food compared with baseline
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	17

Research contact person
Name of lead principal investigator	Osami Kajimoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Medical Science on Fatigue
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	R&D Division
Address	Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Nikken Lease Kogyo Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 20 Day
Anticipated trial start date	2015 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 21 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021174