UMIN-CTR Clinical Trial

Basic information
Public title	An investigation study of drinking oxygenated water effects on oxygen saturations in blood on healthy humans: a randomized, double-blind, placebo-controlled, crossover trial
Acronym	An investigation study of drinking oxygenated water effects on oxygen saturations in blood on healthy humans
Scientific Title	An investigation study of drinking oxygenated water effects on oxygen saturations in blood on healthy humans: a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym	An investigation study of drinking oxygenated water effects on oxygen saturations in blood on healthy humans
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate drinking oxygenated water effects on oxygen saturations in blood on healthy adult subjects
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood oxygen saturations (SpO2) *Assess before consumption, immediately after consumption, and at 15 and 30 seconds after intake.
Key secondary outcomes	1. Blood oxygen saturations (SpO2) 2. Blood flow velocity 3. Visibility of vessels 4. Density of vessels 5. Diameter of vessels 6. Distance between vessels 7. Length of vessels 8. Shape of vessels *1 Assess before consumption, immediately after consumption, and at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 and 60 seconds. *2-8 Assess before consumption, immediately after consumption, and at 15, 30, 45, 60, 75, 90, 105 and 120 seconds.

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	I. Active beverage II. Placebo beverage * The intervention sequence is I-II, and each beverage is single ingestion. * Drink test beverage (125 mL) under a stable state of heart rate *Washout period is for 1 week and more.
Interventions/Control_2	I. Placebo beverage II. Active beverage * The intervention sequence is I-II, and each beverage is single ingestion. * Drink test beverage (125 mL) under a stable state of heart rate *Washout period is for 1 week and more.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who experiences difficulty breathing or fatigue in daily 3. Subjects who measured 97% or less in SpO2 at screening (before intake) 4. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements 6. Subjects who are an allergic reaction to medications 7. Subjects who have severe anemia, peripheral circulatory failure, angiopathy, or respiratory disease 8. Subjects who are wearing nail polish or applying cuticle oil to their nail 9. Subjects who are difficult to test because of hangnail, suppuration, or inflammation on the measurement part of the finger 10. Subjects who are difficult to test because of pigmentation on the measurement part of the finger 11. Subjects who are chipping off the cuticle on fingernails of the measurement part 12. Subjects who are pregnant, breast-feeding, or planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Mediscience Espoir Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 10 Month 29 Day
Date of IRB	2018 Year 10 Month 29 Day
Anticipated trial start date	2018 Year 11 Month 05 Day
Last follow-up date	2018 Year 12 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 02 Day
Last modified on	2019 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039621