UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000027407
Receipt number R000031409
Scientific Title Efficacy study of oral Wasabi-sulfinyl(R) containing foods to improve cognitive function for the middle aged and elderly
Date of disclosure of the study information 2018/09/23
Last modified on 2018/06/15 18:13:18

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Basic information

Public title

Efficacy study of oral Wasabi-sulfinyl(R) containing foods to improve cognitive function for the middle aged and elderly

Acronym

Efficacy study of oral Wasabi-sulfinyl(R) to improve cognitive function

Scientific Title

Efficacy study of oral Wasabi-sulfinyl(R) containing foods to improve cognitive function for the middle aged and elderly

Scientific Title:Acronym

Efficacy study of oral Wasabi-sulfinyl(R) to improve cognitive function

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare and evaluate the effect of a test food on cognitive function before and after ingestion of the test food or placebo

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rey Auditory Verbal Learning Test, Paced Auditory Serial Addition Test

Key secondary outcomes

Tapping Span , Memory of the graphic, Purdue Pegboard Test, Stroop test, Brain-derived neurotrophic factor, questionnaires


Base

Study type

Interventional


Study design

Basic design

Parallel

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

Food

Interventions/Control_1

Ingestion of Wasabi-sulfinyl(R) containing foods for 8 weeks

Interventions/Control_2

Ingestion of placebo for 8 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



Eligibility

Age-lower limit

45 years-old <=

Age-upper limit

69 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Men and women aged from 45 to 69
2) Subjects with self-awareness of forgetfulness
3) Subjects with inferior scores of cognitive function tests

Key exclusion criteria

1) Subjects who are difficult to discriminate color
2) Subjects with bad eyesight, or are diagnosed with amblyopia or blindness
3) Subjects with bad hearing, or are diagnosed with hearing loss or permanent hearing loss
4) Subjects who get a score of 20 or less on the Revised HDS-R
5) Subjects with history of cranial nerve disease
6) Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder
7) Subjects who are under hormone treatment or are diagnosed with menopause
8) Subjects who have some irregular schedules during the study, due to night work or something
9) Subjects who drink much alcohol
10) Subjects who smoke, or quit smoking within one year before pre-inspection
11) Subjects who have done the same cognitive function test within one year before pre-inspection
12) Subjects who are under treatment of cognitive functions, or are prescribed with medicine for them
13) Subjects who continuously take medicine, health foods, Food for Specified Health Uses or Foods with Function Claims including substance related to cognitive functions
14) Subjects who was given or donated 200 ml or 400 ml whole blood within three months before pre-inspection
15) Subjects who participated in other study within one month before pre-inspection, or are going to participate in other study during the study
16) Subjects who have a disease which needs regular medication, or have a history of the disease
17) Subjects who are judged as unsuitable for the study by investigator because of clinical test, anthropometric test and physical examination in pre-inspection
18) Subjects who are in danger of allergy to the study
19) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
20) Subjects who are judged as unsuitable for the study because of lifestyle questionnaire
21) Subjects who are judged as unsuitable for the study by investigator for other reasons

Target sample size

50


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 Pref.

TEL

052-242-0008

Email

i-okunishi@kinjirushi.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kotoha Isobe

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

k.isobe@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 09 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 13 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 25 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

2018 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name