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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034753
Receipt No. R000039621
Official scientific title of the study An investigation study of drinking oxygenated water effects on oxygen saturations in blood on healthy humans: a randomized, double-blind, placebo-controlled, crossover trial
Date of disclosure of the study information 2018/11/02
Last modified on 2018/11/09

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Basic information
Official scientific title of the study An investigation study of drinking oxygenated water effects on oxygen saturations in blood on healthy humans: a randomized, double-blind, placebo-controlled, crossover trial
Title of the study (Brief title) 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, and 30 seconds.
*2-8 Assess before consumption, immediately after consumption, and at 15, 30, 45, and 60 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 Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
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 Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
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 Co.,Ltd.
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 10 Month 29 Day
Anticipated trial start date
2018 Year 11 Month 05 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
2018 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 09 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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