UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034753 |
|---|---|
| Receipt number | R000039621 |
| 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 |
| Date of disclosure of the study information | 2018/11/02 |
| Last modified on | 2019/07/02 10:31:27 |
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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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039621
