UMIN-CTR Clinical Trial

Public title

A study to evaluate the effect of improving makers for oxidative stress and blood vessel elasticity in healthy adults by ingestion of Wasabi-sulfinyl(R) containing foods.

Acronym

A study to evaluate the effect of improving makers for oxidative stress and blood vessel elasticity by ingestion of Wasabi-sulfinyl(R) containing foods.

Scientific Title

A study to evaluate the effect of improving makers for oxidative stress and blood vessel elasticity in healthy adults by ingestion of Wasabi-sulfinyl(R) containing foods.

Scientific Title:Acronym

A study to evaluate the effect of improving makers for oxidative stress and blood vessel elasticity by ingestion of Wasabi-sulfinyl(R) containing foods.

Region

Japan

Condition

None

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of improving anti-oxidant potential and blood vessel elasticity and blood flow by ingestion of Wasabi-sulfinyl(R) containing foods.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

d-ROMs, BAP, anti-oxidant potential, MDA-LDL, LPO

Key secondary outcomes

baPWV, blood flow, hs-CRP, Fatigue sensation (VAS), skin questionnaire, AIS, PSQI-j

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of Wasabi-sulfinyl(R) containing foods for 12 weeks

Interventions/Control_2

Ingestion of placebo for 12 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Males and females aged 20 to less than 65 years old.
(2) Those who have feeling of fatigue at screening.
(3) Those who have consciousness that sleep is not sufficient at screening.
(4) Those who have a lower anti-oxidant potential at screening.

Key exclusion criteria

(1) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food.
(2) With allergy to the study foods.
(3) Subjects who has a disease under treatment.
(4) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease or cancer).
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
(6) Subjects who are alcohol consumption ( more than 60g/day) / subjects who are excess smorker ( more than 21/day).
(7) 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.
(8) Subjects who have participated in other clinical study within the last one month prior to the current study.
(9) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(11) Subjects who are judged as unsuitable by doctor for other reasons.

Target sample size

50

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

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

Institute

TTC Co.,Ltd

Institute

Department

Personal name

Organization

KINJIRUSHI Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

04

Month

27

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

19

Day

Last modified on

2017

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031403