UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030194 |
|---|---|
| Receipt number | R000034491 |
| Scientific Title | Evaluation of improvement of higher brain function and safety by Collagen food containing tripeptide and cyclic dipeptide intake. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2018/12/26 18:58:11 |
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Basic information
Public title
Evaluation of improvement of higher brain function and safety by Collagen food containing tripeptide and cyclic dipeptide intake.
Acronym
Evaluation of improvement of higher brain function and safety test
Scientific Title
Evaluation of improvement of higher brain function and safety by Collagen food containing tripeptide and cyclic dipeptide intake.
Scientific Title:Acronym
Evaluation of improvement of higher brain function and safety test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate the improvement of higher brain function and safety by two foods with different contents intake, we conduct single blind group comparison study and evaluate height measurement, blood test, health diary, doctor's findings and evaluations, physical measurement, measurement of blood pressure and pulse, and RBANS test.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2 month later , evaluation of cognitive functions by RBANS
Key secondary outcomes
Blood test
Health diary
Doctor's findings and evaluations
Height measurement
Physical measurement
Measurement of blood pressure and pulse
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low dose:1 bag once a day :During meals once a day, take in miso soup, coffee, tea etc. together with hot drinks that are usually drunk and ingest them together. Or take a meal with water or lukewarm water.
Interventions/Control_2
High dose:6 tablets once a day :After meals once a day, ingest with water or lukewarm water.
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Japanese male and female at the age of 40 to 69 at first observation including screening.
2 A person who feels more forgetful than early life.
Key exclusion criteria
1 A person who possibly shows food allergy symptom.
2 A person who had been treated, hospitalized or operated for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral haemorrhage, brain contusion or head trauma.
3 A person who is alcohol or nicotine addict, or whose dietary habit is extremely irregular.
4 A person with medical history or current illness of hepatic disorder.
5 A person with severe anemia.
6 A person with medical history of epileptic stroke, diabetes, thyroid dysfunction or severe renal dysfunction(hemodialysis, uremia, anuria), or attending the hospital regularly for these disorder.
7 A person who has taken a neuropsychological test at hospital.
8 A person who joins other human clinical study.
9 A person who is routinely taking medicines (e.g. antipsychotic, antianxiety agent, antidepressant, antiparkinson agent, antimanic agent, anticonvulsant, anticoagulant agent) which possibly affects the test results.
10 A person who is routinely taking health foods (supplements effective for antioxidative, blood flow-ameliorating and so on) which possibly affects the test results.
11 A person who is judged inappropriate to join the study by doctor in charge. (Subject who is judged inappropriate during this test is excluded from targets of analysis. In addition, a criterion not in screening criteria is not included in exclusion criteria for screening.)
12 A person who have taken an RBANS test in 3 month before main test schedule.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
Address
6F DaiwaA Hamamatucho Bld., 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 | |
| Middle name | |
| Last name | Ko MASUDA |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
JELLICE Co., 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
Address
Tel
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
| 2017 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034491
