UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on cognitive function improving effect for adult healthy men and women
Title of the study (Brief title)	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	Tetsuya Hirata
Organization	KOBAYASHI Pharmaceutical Co., Ltd.
Division name	Healthcare Division
Address	1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL	072-640-0131
Email	t.hirata@kobayashi.co.jp

Public contact
Name of contact person	Takashi Nakagawa
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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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