UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027064 |
|---|---|
| Receipt number | R000031026 |
| Scientific Title | Clinical study on the effect of milk-derived peptide on the cognitive function in the elderly volunteers. |
| Date of disclosure of the study information | 2017/04/19 |
| Last modified on | 2019/03/04 09:28:24 |
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Basic information
Public title
Clinical study on the effect of milk-derived peptide on the cognitive function in the elderly volunteers.
Acronym
Clinical study on the effect of milk-derived peptide on the cognitive function in the elderly volunteers.
Scientific Title
Clinical study on the effect of milk-derived peptide on the cognitive function in the elderly volunteers.
Scientific Title:Acronym
Clinical study on the effect of milk-derived peptide on the cognitive function in the elderly volunteers.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the beneficial effect by milk-derived peptide on the cognitive function in the elderly volunteers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes is Rey-Osterrieth Complex Figure Test (ROCF) at pre and post (for 24 weeks) administration of the repeated intake of milk-derived peptide.
Key secondary outcomes
Secondary outcome is the tests below.
MMSE
Symbol Digit Modalities Test
Verbal Fluency Test
SF-8
Questionnaire
physical examination
hematology test
urinalysis test
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
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food including milk-derived peptide (24 weeks, 4 tablets / once a day)
Interventions/Control_2
Ingestion of placebo food not including milk-derived peptide (24 weeks, 4 tablets / once a day)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The subjects who agreed in the written sheet to participate this intervention study.
2) The subjects who are aware of forgetfulness.
3) The subjects who can intake test foods during the test period.
4) The subjects who are able to check the diary of food intake during the intake period.
5) The subjects who displayed from 24 to 27 scores of MMSE.
Key exclusion criteria
1) The subjects who are likely to have allergy symptoms due to test ingredients (milk).
2) The subjects who were diagnosed as patients with dementia
3) The subjects who received surgical operation for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion injury Head trauma Those with the inpatient surgery.
4) The subjects with medical history of epilepsy or diabetes and/or receiving medical treatment presently.
5) The subjects who is taking medicines (antipsychotic drugs, anxiolytics, antidepressants, antiparkinsonian drugs, antidepressants, antiepileptic drugs etc.) that have a possibility affecting on the cognitive function.
6) The subjects who are participating or planning to participate in other clinical trials at the start of this study.
7) The subjects who are judged as being inappropriate by the responsible doctor.
Target sample size
114
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamada Shizuo |
Organization
University of Shizuoka
Division name
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
054-264-5625
yamada@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamada Shizuo |
Organization
University of Shizuoka
Division name
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
054-264-5625
Homepage URL
yamada@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Shizuoka, School of Pharmaceutical Sciences, Drug Information Analysis
Seirei Social Welfare Community
Toho University Sakura Hospital
Koga Community Hospital
Hagiwara Hospital
Takido Hospital
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
静岡県立大学 薬食生命科学総合学府 薬学研究院 薬食研究推進センター/Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 19 | 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 | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 16 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 18 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031026
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