UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023963 |
|---|---|
| Receipt number | R000027257 |
| Scientific Title | Effects of Single Ingestion of Hydrogen Water (Generated through Hydrogen Water Server) on Blood Flow: A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial |
| Date of disclosure of the study information | 2016/09/10 |
| Last modified on | 2017/02/09 09:31:23 |
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Basic information
Public title
Effects of Single Ingestion of Hydrogen Water (Generated through Hydrogen Water Server) on Blood Flow: A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial
Acronym
Effects of Single Ingestion of Hydrogen Water (Generated through Hydrogen Water Server) on Blood Flow
Scientific Title
Effects of Single Ingestion of Hydrogen Water (Generated through Hydrogen Water Server) on Blood Flow: A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial
Scientific Title:Acronym
Effects of Single Ingestion of Hydrogen Water (Generated through Hydrogen Water Server) on Blood Flow
Region
| Japan |
Condition
Condition
N/A (healthy adults or adults being sensitive to the cold)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effects of single ingestion of hydrogen water (generated through hydrogen water server) on blood flow.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Blood flow speed at the end of fingers (Preliminary observation, First observation, Second observation)
[2]Blood flow (First observation, Second observation)
Key secondary outcomes
[1]Weight, body fat percentage, BMI (Preliminary observation, First observation, Second observation)
[2]Blood pressure, pulsation (Preliminary observation, First observation, Second observation)
[3]Body temperature (Preliminary observation, First observation, Second observation)
[4]Doctor's questions (Preliminary observation, First observation, Second observation)
[5]Simplified Menopausal Index (Preliminary observation)
[6]Subject's diary (each day during the test period)
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
[1]Oral intake of the test product (hydrogen water, 1 time)
[2]Observation
[3]Washout (1 week)
[4]Oral intake of the placebo product (not hydrogen water, 1 time)
[5]Observation
Interventions/Control_2
[1]Oral intake of the placebo product (not hydrogen water, 1 time)
[2]Observation
[3]Washout (1 week)
[4]Oral intake of the test product (hydrogen water, 1 time)
[5]Observation
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Japanese healthy females aged 35-59 years
[2]Individuals who are sensitive to the cold
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can come to the designated venue for this study and be inspected
[5]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia
[3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis)
[4]Individuals who conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[6]Individuals who are a patient or have a history of or endocrine disease
[7]Individuals with serious anemia
[8]Individuals who are sensitive to a test product or other foods, and medical products
[9]Individuals who have a habit to intake hydrogen water
[10]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 months or will ingest those foods during the test period
[11]Individuals who have an inflammation or a scar on a measuring area
[12]Individuals whose BMI is over 25
[13]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg
[14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[15]Individuals who are a smoker
[16]Individuals who participated in other clinical studies in the past 3 months
[17]Individuals whose SMI score is over 66
[18]Individuals who have a history of ovarian resection or hysterectomy
[19]Individuals who are or are posslibly, or are lactating
[20]Individuals judged inappropriate for the study by the principal
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Nakata |
Organization
Medical Corporation Bokushinkai CLINTEXE Clinic
Division name
Director
Zip code
Address
4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL
03-5405-1059
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Tamura |
Organization
TES Holdings Co., Ltd.
Division name
Division of Clinical Trial, Department of Development for Clinical Trials
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan
TEL
03-6801-8480
Homepage URL
info@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
SEEMS Bionics Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 10 | 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
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
| 2016 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 07 | Day |
Last modified on
| 2017 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027257
