UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on the health promotion effect by intake of WASABI Sulfinyl(R) containing supplement.
Acronym	Exploratory study on the health promotion effect by intake of WASABI Sulfinyl(R) containing supplement.
Scientific Title	Exploratory study on the health promotion effect by intake of WASABI Sulfinyl(R) containing supplement.
Scientific Title:Acronym	Exploratory study on the health promotion effect by intake of WASABI Sulfinyl(R) containing supplement.
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploratory evaluation of the effect on health promotion for adults (20 to 64 years old) by intake of WASABI Sulfinyl(R) containing supplement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urinary 8-OHdG and urinary creatinine before and after continuous intake for 4 weeks.
Key secondary outcomes	Following items before and after continuous intake for 4 weeks. -urinary indoxyl sulfate -urinary sodium -quantity of Semen* -count of Sperm* -concentration of Sperm* -testosterone in semen* -creatine in semen* -zinc in semen* -spermine in semen* -questionnaire(lifestyle,compliance with study food intake, etc.) *measure only for men

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of WASABI Sulfinyl(R) containing supplement for 4 weeks.
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese who are 20 years old or more and under 65 years old
Key exclusion criteria	1.Persons who have chronic illness 2.Persons who are allergic to the test food 3.Persons who daily use medicines, foods for specified health uses, health foods and supplements that may affect oxidative stress 4.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 5.Persons who were judged as inappropriate for subjects by the principal investigator 6.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hirohito Middle name Last name Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-5562-8825
Email	ishikawa@hc-sys.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Tsukamoto
Organization	Healthcare Systems Co., Ltd.
Division name	Sales Planning Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	050-3640-3595
Homepage URL
Email	tsukamoto@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	TEIJIN LIMITED
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	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	soumu@hc-sys.jp

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	2020 Year 04 Month 21 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	60
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	2020 Year 04 Month 18 Day
Date of IRB	2020 Year 04 Month 18 Day
Anticipated trial start date	2020 Year 05 Month 21 Day
Last follow-up date	2020 Year 07 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 21 Day
Last modified on	2020 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045860