UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy study of oral Ginkgo biloba extract to improve brain function for the middle aged and elderly
Title of the study (Brief title)	Efficacy study of oral Ginkgo biloba extract to improve brain function
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare and evaluate the effect of a test food on brain 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, Standard verbal paired-associate learning test, Paced Auditory Serial Addition Test
Key secondary outcomes	Stroop test

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	The treatment group will receive oral administration of three tablets including 168 mg Ginkgo biloba extract.
Interventions/Control_2	The placebo group will receive oral administration of three Ginkgo biloba extract-free tablets
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 brain 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 brain function test before 12) Subjects who are under treatment of brain 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 brain 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 taking warfarin in the brain infarction or heart or need to take warfarin during 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	44

Research contact person
Name of lead principal investigator	Ryuji Tabata
Organization	Itty, INC.
Division name	None
Address	1-27-7, Higashi, Shibuya-ku, TOKYO, 150-0011 JAPAN
TEL	03-6418-4875
Email	tabata@itty.co.jp

Public contact
Name of contact person	Kotoha Isobe
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.isobe@ttc-tokyo.co.jp

Sponsor
Institute	Itty, INC.
Institute
Department

Funding Source
Organization	Itty, INC.
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	医療法人健昌会 福島健康管理センター

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 09 Month 10 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	2016 Year 09 Month 09 Day
Last modified on	2017 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027614