UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of intake of test foods on cognitive functions
Acronym	A study for the effect of intake of test foods on cognitive functions
Scientific Title	A study for the effect of intake of test foods on cognitive functions
Scientific Title:Acronym	A study for the effect of intake of test foods on cognitive functions
Region	Japan

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

Objectives
Narrative objectives1	A study for the effect of intake of test foods on cognitive functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tests for cognitive functions
Key secondary outcomes	Measurements of cerebral blood flow 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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food,6 tablets a day, 12 weeks
Interventions/Control_2	Intake of placebo 6 tablets a day, 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

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Healthy men and women aged from 50 to 75 2)Subjects with self-awareness of cognitive decline such as forgetfulness or carelessness 3)Subjects whose primary language is Japanese
Key exclusion criteria	1)Subjects who have difficulties in performing cognitive tests due to the low visual acuity or the low hearing acuity. 2)Subjects who are suspected of dementia. 3)Subjects who have anamnesis of cranial nerve disease 4)Subjects who have depressive symptoms, or who have been to diagnosed as depressive disorders 5) Subjects who are being treated with hormone, or who have been diagnosed as menopausal symptoms 6)Subjects who sometimes have irregular lifestyles during the study 7)Heavy drinkers 8)Smokers or subjects who started smoking cessation within 12 months 9)Subjects who have taken the similar cognitive function tests within 12 months 10)Subjects who are being treated for cognitive functions, or who are prescribed drugs associated with cognitive functions 11)Subjects who regularly take drugs or health foods which may affect cognitive functions more than once a week 12)Subjects who regularly take foods similar to test foods more than once a week 13)Subjects who have diseases requiring regular administration, or who have severe diseases 14)Subjects who may have physical deconditioning due to test foods 15) Subjects who are, or are planning to be pregnant or breastfeeding during study 16)Subjects who and whose family work in a company developing functional foods
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kuniaki Obara
Organization	Kirin company, Limited
Division name	Research and Development division, Research Laborarories for Health Science and Food Technologies
Zip code
Address	1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan
TEL	080-1930-9932
Email	k-obara@kirin.co.jp

Public contact
Name of contact person	1st name Middle name Last name Ko MASUDA
Organization	SOUKEN Co., Ltd
Division name	Management Division
Zip code
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	SOUKEN Co., Ltd
Institute
Department

Funding Source
Organization	Kirin company, Limited
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	2019 Year 06 Month 29 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	Main results already published
Date of protocol fixation	2017 Year 11 Month 02 Day
Date of IRB	2017 Year 02 Month 02 Day
Anticipated trial start date	2018 Year 01 Month 08 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 19 Day
Last modified on	2021 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034777