UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of intake of ingredients derived from plant on cognitive functions
Acronym	A study for the effect of intake of ingredients derived from plant on cognitive functions
Scientific Title	A study for the effect of intake of ingredients derived from plant on cognitive functions
Scientific Title:Acronym	A study for the effect of intake of ingredients derived from plant on cognitive functions
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 ingredients derived from plant on cognitive functions
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 Tests for mental status 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 food containing ingredients derived from plant, 3 capsules a day, 12 weeks
Interventions/Control_2	Intake of placebo 3 capsules 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	45 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who fall under all of the following 1) to 6) 1)Men and women aged from 45 to 64 2)Subjects whose primary language is Japanese 3)Subjects with self-awareness of decline of the brain or forgetfulness 4)Subjects who often forget the name of people or objects 5)Subjects who often carelessly make mistakes in daily life 6)Subjects with inferior scores of primary outcome in preliminary test
Key exclusion criteria	1)Subjects who have difficulties in recognition of colors 2)Subjects whose visual acuity is too low to perform tests, or who have been diagnosed as amblyopia or blindness 3)Subjects whose hearing acuity is too low to perform test, or who have been diagnosed as deafness 4)Subjects whose score of the HDS-R is less than 20 5)Subjects who have anamnesis of cranial nerve disease 6)Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder 7)Subjects who are being treated with hormone, or who have been diagnosed as menopausal symptoms 8)Subjects who sometimes have irregular lifestyles during the study 9)Heavy drinkers 10)Smokers or subjects who started smoking cessation within 12 months 11)Subjects who have taken the similar cognitive function tests within 12 months 12)Subjects who are being treated for cognitive functions, or who are prescribed drugs associated with cognitive functions 13)Subjects who suffer from sleep related diseases 14)Subjects who regularly take drugs or health foods which may affect study results more than once a week 15)Subjects who have done blood transfusion or blood donation within 3 months 16)Subjects who regularly take foods similar to test foods more than once a week 17)Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study 18)Subjects who have diseases requiring regular administration, or who have severe diseases 19)Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value 20)Subjects who may have allergy to test foods 21)Subjects who are, or are planning to be pregnant or breastfeeding during study 22)Subjects who are judged as unsuitable due to lifestyle questionnaire 23)Subjects who or whose family work in a company developing or manufacturing functional foods 24)Subjects who are judged as unsuitable by doctor for other reasons
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kuniaki Middle name Last name Obara
Organization	Kirin company, Limited
Division name	Research Laboratories for Health Science and Food Technologies, Research and Development Division
Zip code	236-0004
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 Isobe Middle name Last name Kotoha
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Zip code	2360004
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
Institute	TTC 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	Ueno clinic
Address	2-18-6, Higashi-Ueno, Taito-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.jp

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 04 Month 14 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	2017 Year 09 Month 28 Day
Anticipated trial start date	2017 Year 10 Month 18 Day
Last follow-up date	2018 Year 04 Month 28 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 10 Month 16 Day
Last modified on	2019 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033783