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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029559
Receipt No. R000033775
Scientific Title A Study on cognitive function improving effect for adult healthy men and women
Date of disclosure of the study information 2018/12/20
Last modified on 2018/12/20

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Basic information
Public title A Study on cognitive function improving effect for adult healthy men and women
Acronym A Study on cognitive function improving effect for adult healthy men and women
Scientific Title A Study on cognitive function improving effect for adult healthy men and women
Scientific Title:Acronym A Study on cognitive function improving effect for adult healthy men and women
Region
Japan

Condition
Condition None (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of intake of a test food on cognitive function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tests for memory functions
Key secondary outcomes Tests for memory functions
Tests for attention functions
Tests for executive functions
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 a test food for 20 consecutive weeks
Interventions/Control_2 Ingestion of placebo for 20 consecutive 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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Male and female aged 50 and older
2) Subjects with self-awareness of forgetfulness but who are judged healthy by a doctor
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 with history of cranial nerve disease
5) Subjects who are under treatment of cognitive functions, or are prescribed with medicine for them
6) Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder
7) Subjects who diagnosed with dementia or MCI by a doctor at screening test
8) Subjects who are under hormone treatment or are diagnosed with menopause
9) Subjects who have a pain or disease at wrist or arm
10) Subjects who have some irregular schedules during the study, due to night work or something
11) Subjects who drink much alcohol
12) Subjects who smoke, or quit smoking within one year before screening test
13) Subjects who have done the same cognitive function test within one year before screening test
14) Subjects who continuously take medicine, health foods, Food for Specified Health Uses or Foods with Function Claims including substance related to cognitive functions
15) Subjects who was given or donated 200 mL or 400 mL of whole blood within three months before screening test
16) Subjects who participated in other study within one month before screening test, or are going to participate in other study during the study
17) Subjects who have a disease which needs regular medication, or have a history of the disease
18) Subjects who are judged as unsuitable for the study by investigator because of clinical test, anthropometric test and physical examination in screening test
19) Subjects who are in danger of allergy to the study
20) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
21) Subjects who are judged as unsuitable for the study because of lifestyle questionnaire
22) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Hirata
Organization KOBAYASHI Pharmaceutical Co., Ltd.
Division name Healthcare Division
Zip code
Address 1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL 072-640-0131
Email t.hirata@kobayashi.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakagawa
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 t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization KOBAYASHI Pharmaceutical 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 12 Month 20 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 09 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 24 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 10 Month 15 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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