UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027402
Receipt number R000031405
Scientific Title A study to evaluate the safety of excessive ingestion of Wasabi-sulfinyl(R) containing foods for healthy adults.
Date of disclosure of the study information 2018/07/23
Last modified on 2017/10/05 16:25:58

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Basic information

Public title

A study to evaluate the safety of excessive ingestion of Wasabi-sulfinyl(R) containing foods for healthy adults.

Acronym

A study to evaluate the safety of excessive ingestion of Wasabi-sulfinyl(R) containing foods.

Scientific Title

A study to evaluate the safety of excessive ingestion of Wasabi-sulfinyl(R) containing foods for healthy adults.

Scientific Title:Acronym

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

1st name
Middle name
Last name Isao Okunishi

Organization

KINJIRUSHI Co., Ltd.

Division name

Development Division

Zip code


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

1st name
Middle name
Last name Shingo Yamamichi

Organization

TTC Co.,Ltd

Division name

Clinical Research Planning Department

Zip code


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 or person

Institute

TTC Co.,Ltd

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2017 Year 04 Month 27 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name