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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027064
Receipt No. 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

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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
Email 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
Email yamada@u-shizuoka-ken.ac.jp

Sponsor
Institute Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences, University of Shizuoka
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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