UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the safety of excessive ingestion of Wasabi-sulfinyl(R) containing foods for healthy adults.
Title of the study (Brief title)	A study to evaluate the safety of excessive ingestion of Wasabi-sulfinyl(R) containing foods.
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of excessive ingestion of Wasabi-sulfinyl(R) containing foods for 4 weeks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight Doctor's questions Adverse event
Key secondary outcomes

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	Ingestion of Wasabi-sulfinyl(R) containing foods (5 tablets per day, 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy males and females aged 20-64 years.
Key exclusion criteria	(1) With allergy to the study foods. (2) Subjects who has a disease under treatment. (3) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease or cancer). (4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination. (5) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas. (6) Subjects who have participated in other clinical study within the last one month prior to the current study. (7) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (9) Subjects who are judged as unsuitable by doctor for other reasons.
Target sample size	11

Research contact person
Name of lead principal investigator	Isao Okunishi
Organization	KINJIRUSHI Co., Ltd.
Division name	Development Division
Address	Nadya Park Business Center Building 23F, 3-18-1, Sakae, Naka-ku, Nagoya-shi, Aichi
TEL	052-242-0008
Email	i-okunishi@kinjirushi.co.jp

Public contact
Name of contact person	Shingo Yamamichi
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd
Institute
Department

Funding Source
Organization	KINJIRUSHI Co., Ltd.
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	2018 Year 07 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 27 Day
Anticipated trial start date	2017 Year 05 Month 22 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	2017 Year 05 Month 19 Day
Last modified on	2017 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031405