UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study on the effect of milk-derived peptide on the cognitive function in the elderly volunteers.
Title of the study (Brief title)	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	Yamada Shizuo
Organization	University of Shizuoka
Division name	Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
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	Yamada Shizuo
Organization	University of Shizuoka
Division name	Center for Pharma-Food Research, Graduate School of Pharmaceutical Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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