UMIN-CTR Clinical Trial

Public title

Study 1 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function

Acronym

Study 1 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function

Scientific Title

Study 1 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function

Scientific Title:Acronym

Study 1 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study was to investigate the effects of continuous intake of test foods for 12 weeks on cognitive function of Japanese men and women who are aware of decline in cognitive function when they are 50 years of age or older and 69 years of age or younger.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Cognitrax,MMSE

Key secondary outcomes

Pittsburgh Sleep Quality Index, Blood BDNF, Blood Abeta (1-40, 1-42, oligomers), Blood sAPP alpha, MicroRNAs

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12-week intake of the test food

Interventions/Control_2

12-week intake of the placebo food

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

50

years-old

<=

Age-upper limit

69

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Japanese men and women aged 50 to 69 years at the time of informed consent
2) Those who are aware of cognitive decline
3) Persons able to take one capsule daily for 12 weeks
4)Persons with an M MMSE score of 24 or more
5) Non smoker
6) A person who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.

Key exclusion criteria

1) Subjects who are currently receiving any medications or outpatient treatment.
2) History of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease
Or those with a merger
3) Patients with a history of drug or food allergy
4) People who use health foods and supplements that may affect cognitive function
5) Persons using drugs that may affect cognitive function
6) Persons with extreme skipped eating
7) Excessively irregular lifestyle such as eating or sleeping
8) Patients suspected of having insomnia (insomnia, sleep apnea syndrome, etc.)
9) Persons with a current or past history of psychiatric disorders (depression, etc.)
10) Persons with a current or past history of alcoholism
11) Subjects who have participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period.
12) Persons whose working hours are irregular, such as those who have worked at night.
13) Subjects who are pregnant, breast-feeding, or willing to become pregnant during the study period
14) Persons who are difficult to comply with the records of various surveys
15) Other than the above, the principal investigator judged that the subject was ineligible for the study.

Target sample size

52

Name of lead principal investigator

1st name
Middle name
Last name	Takihara Takanobu

Organization

ITO EN, Ltd.

Division name

Central Research Institute

Zip code

Address

21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan

TEL

0548-54-1247

Email

t-takihara@itoen.co.jp

Name of contact person

1st name
Middle name
Last name	Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Homepage URL

Email

ochitani@huma-rd.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

ITO EN,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

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

Date of disclosure of the study information

2018

Year

08

Month

31

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

2018

Year

07

Month

13

Day

Date of IRB

Anticipated trial start date

2018

Year

09

Month

03

Day

Last follow-up date

2018

Year

12

Month

06

Day

Date of closure to data entry

2018

Year

12

Month

11

Day

Date trial data considered complete

2019

Year

01

Month

10

Day

Date analysis concluded

2019

Year

04

Month

30

Day

Other related information

Registered date

2018

Year

08

Month

20

Day

Last modified on

2019

Year

01

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038264