UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of milk protein hydrolysates intake on higher cerebral functions in elderly persons.
Title of the study (Brief title)	Effect of milk protein hydrolysates intake on cerebral functions in elderly persons.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of milk protein hydrolysates intake on higher cerebral functions in elderly persons.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Reaction time of cognitive test
Key secondary outcomes	Correct answer ratio of test Functional MRI

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	Central registration

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Milk protein hydrolysates (40mg/kg-bw, single dose)
Interventions/Control_2	Milk protein (40mg/kg-bw, single dose)
Interventions/Control_3	Dietary Fiber (40mg/kg-bw, single dose)
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) Subjects who can receive a MRI examination. 2) Subjects who have no problems in daily life.
Key exclusion criteria	1) Subjects with MMSE test score less than 24. 2) Subjects with cognitive impairment by cerebrovascular disease or Alzheimer's disease. 3) Subjects with heart disease. 4) Subjects who had heart attack or cerebral stroke within 6 months. 5) Subjects with acute hepatic dysfunction or active chronic viral hepatitis. 6) Diabetic patients with retinopathy or nephropathy or history of hypoglycemic attack or fasting blood glucose more than 200mg/dl. 7) Subjects with systolic blood pressure more than 180mmHg or diastolic blood pressure more than 110mmHg. 8) Subjects with acute orthopedic pain or neurologic manifestation. 9) Subjects with osteoporosis and history of compression fracture. 10) Subjects with milk allergy. 11) Subjects who regularly use supplements that may influence cerebral function; e.g. DHA, EPA, Catechin. 12) Patients who are judged inappropriate for the study by principal investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	Ken Kimura
Organization	Tokyo Denki University
Division name	School of Engineering, Department of Humanities and Social Science
Address	5 Senju-Asahi-cho, Adachi-ku, Tokyo
TEL	03-5284-5635
Email	kimura@cck.denki.ac.jp

Public contact
Name of contact person	Ken Kimura
Organization	Tokyo Denki University
Division name	School of Engineering, Department of Humanities and Social Science
Address	5 Senju-Asahi-cho, Adachi-ku, Tokyo
TEL	03-5284-5635
Homepage URL
Email	kimura@cck.denki.ac.jp

Sponsor
Institute	Tokyo Denki University
Institute
Department

Funding Source
Organization	Morinaga Milk Industry Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 04 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 04 Month 05 Day
Date analysis concluded

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

Management information
Registered date	2016 Year 10 Month 04 Day
Last modified on	2018 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027973