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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033813 |
Receipt No. | R000038266 |
Scientific Title | Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function |
Date of disclosure of the study information | 2018/09/07 |
Last modified on | 2019/01/17 |
Basic information | ||
Public title | Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function | |
Acronym | Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function | |
Scientific Title | Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function | |
Scientific Title:Acronym | Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function | |
Region |
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Condition | ||
Condition | Healthy subjects | |
Classification by specialty |
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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, Blood BDNF, Blood Abeta (1-40, 1-42, oligomers), Blood sAPP alpha, MicroRNAs |
Base | |
Study type | Interventional |
Study design | |
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 |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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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 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 3 capsules 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. |
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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. |
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Target sample size | 52 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | ITOEN,Ltd. | ||||||
Division name | Central Research Institute | ||||||
Zip code | |||||||
Address | 21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan | ||||||
TEL | 0548-54-1247 | ||||||
t-takihara@itoen.co.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
ochitani@huma-rd.co.jp |
Sponsor | |
Institute | HUMA R&D CORP |
Institute | |
Department |
Funding Source | |
Organization | ITOEN,LTD. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038266 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |