UMIN-CTR Clinical Trial

Public title

Efficacy study of oral Ginkgo biloba extract to improve brain function for the middle aged and elderly

Acronym

Efficacy study of oral Ginkgo biloba extract to improve brain function

Scientific Title

Efficacy study of oral Ginkgo biloba extract to improve brain function for the middle aged and elderly

Scientific Title:Acronym

Efficacy study of oral Ginkgo biloba extract to improve brain function

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Rey Auditory Verbal Learning Test, Standard verbal paired-associate learning test, Paced Auditory Serial Addition Test

Key secondary outcomes

Stroop test

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Ryuji Tabata

Organization

Itty, INC.

Division name

None

Zip code

Address

1-27-7, Higashi, Shibuya-ku, TOKYO, 150-0011 JAPAN

TEL

03-6418-4875

Email

tabata@itty.co.jp

Name of contact person

1st name
Middle name
Last name	Kotoha Isobe

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

k.isobe@ttc-tokyo.co.jp

Institute

Itty, INC.

Institute

Department

Personal name

Organization

Itty, INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人健昌会 福島健康管理センター

Date of disclosure of the study information

2016

Year

09

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

08

Month

25

Day

Date of IRB

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

Other related information

Registered date

2016

Year

09

Month

09

Day

Last modified on

2017

Year

03

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027614