UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051061 |
|---|---|
| Receipt number | R000058225 |
| Scientific Title | Evaluation study for intake of cyclic dipeptide on improvements in cognitive function |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2023/05/15 15:08:57 |
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Basic information
Public title
Evaluation study for intake of cyclic dipeptide on improvements in cognitive function
Acronym
Evaluation study for intake of cyclic dipeptide on improvements in cognitive function
Scientific Title
Evaluation study for intake of cyclic dipeptide on improvements in cognitive function
Scientific Title:Acronym
Evaluation study for intake of cyclic dipeptide on improvements in cognitive function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate improvements in cognitive function by taking cyclic dipeptide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RBANS
Cognitrax
(before and 12 weeks after intake)
Key secondary outcomes
SF-36v2
WHO-5J
body mass and BMI
blood pressure, pulsation
subjects' diary
doctor's questions
(before and 12 weeks after intake)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake cyclic dipeptide for 12 weeks
Interventions/Control_2
Intake placebo for 12 weeks
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 60 to 75 years old at the time of informed consent
2) Subjects who feel that they are more forgetful compared with their younger days
Key exclusion criteria
1) Subjects judged inappropriate for the study by the principal
2) Subjects who are participating in other clinical trials
3) Subjects who are taking medicines that can affect the test result
4) Subjects who are taking supplements that can affect the test result
5) Subjects who took RBANS by 3 months before the start of the test
6) Subjects who can be allergic to the test food
7) Subjects who have had a stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion, or head injury resulting in hospitalization for treatment or surgery
8) Excessive tobacco and alcohol users and those with extremely irregular eating habits
9) Subjects with medical history of hepatitis
10) Subjects with severe anemia
11) Subjects with medical history or medical treatments of Epileptic seizures, diabetes, thyroid dysfunction, or severe renal dysfunction (hemodialysis, uremia, anuria)
12) Subjects who have taken neuropsychological tests in the hospital
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
JELLICE
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2023 | Year | 05 | Month | 22 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058225
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
