UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036578 |
|---|---|
| Receipt number | R000041526 |
| Scientific Title | Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function |
| Date of disclosure of the study information | 2019/04/26 |
| Last modified on | 2020/01/29 09:13:20 |
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Basic information
Public title
Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Acronym
Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title
Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title:Acronym
Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
Cognitrax,MMSE
Key secondary outcomes
Pittsburgh Sleep Quality Index
Uchida-Klepelin test
Brain-derived neurotrophic factor
Amyloid-beta (1-40, 1-42)
Secreted Amyloid Precursor Protein-alpha
Amyloid Precursor Protein 770
MicroRNA
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week intake of the test food1
Interventions/Control_2
12-week intake of the test food2
Interventions/Control_3
12-week intake of the placebo food
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
| 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) Subject who is aware of cognitive decline
3) Subject who is able to take 3 capsules daily for 12 weeks.
4) Subject with an MMSE score of 24 or more
5) Non smoker
6) Subject 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) Subject who is currently receiving any medications or outpatient treatment.
2)Subject who is currently doing exercise or diet under the supervision of a doctor
3)Subject who is may develop allergy due to the test food
4)Subject who is drug dependent, present or dependent on alcohol
5) Subject who is history of psychiatry during hospitalization due to mental disorder (depression etc.) or sleep disorder (insomnia, sleep apnea syndrome etc.)
6)Night shift or shift workers
7) Excessively irregular lifestyle such as eating or sleeping
8) Subject who is extreme skipped eating
9)Subject who is current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases
10)Subject who is use health foods, supplements, and medicines that may affect cognitive function
11) Subject who is 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)Subject who is carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition
13) Subject who is pregnant, breast-feeding, or willing to become pregnant during the study period
14)Subject who is difficult to comply with the records of various surveys
15)Subject who is judged to be unsuitable as subject from clinical laboratory test value and measurement value at the time of SCR
16)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Takanobu |
| Middle name | |
| Last name | Takihara |
Organization
ITOEN,Ltd.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
0548-54-1247
t-takihara@itoen.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
ITOEN,LTD.
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
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
jim@medipharma.co.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 | 26 | 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
51
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
| 2019 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 21 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 23 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041526
