UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Single Ingestion of Hydrogen Water (Generated through Hydrogen Water Server) on Blood Flow: A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial
Title of the study (Brief title)	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	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Director
Address	4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL	03-5405-1059
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Division of Clinical Trial, Department of Development for Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027257