UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019265
Receipt number R000022277
Scientific Title Effect of milk peptides on higher central nervous system in elderly persons.
Date of disclosure of the study information 2015/10/15
Last modified on 2016/08/03 13:24:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of milk peptides on higher central nervous system in elderly persons.

Acronym

Effect of milk peptides on higher central nervous system in elderly persons.

Scientific Title

Effect of milk peptides on higher central nervous system in elderly persons.

Scientific Title:Acronym

Effect of milk peptides on higher central nervous system 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 peptides on the higher central nervous system in elderly persons.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reaction time of task-switching test

Key secondary outcomes

Correct answer ratio of task
Functional MRI
Structural change of higher central nervous system


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Peptides(2.5g/day, 4weeks)

Interventions/Control_2

barley tea

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) Subjects who can get 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 diagnosis of dementia 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 phase of chronic viral hepatitis.
6) Diabetic patients with retinopathy or nephropathy or history of hypoglycemic attack or 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 use regularly supplements that may influence cerebral function; e.g. DHA, EPA, Catechin.
12) Patients who are judged inappropriate for the study by the physician.

Target sample size

14


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Kimura

Organization

Tokyo Denki University

Division name

School of Engineering, Department of Humanities and Social Science

Zip code


Address

5 Senju-Asahi-cho, Adachi-ku, Tokyo

TEL

03-5284-5635

Email

kimura@cck.denki.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken Kimura

Organization

Tokyo Denki University

Division name

School of Engineering, Department of Humanities and Social Science

Zip code


Address

5 Senju-Asahi-cho, Adachi-ku, Tokyo

TEL

03-5284-5635

Homepage URL


Email

kimura@cck.denki.ac.jp


Sponsor or person

Institute

Tokyo Denki University

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 15 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

2015 Year 10 Month 05 Day

Date of IRB


Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date

2016 Year 02 Month 25 Day

Date of closure to data entry

2016 Year 02 Month 25 Day

Date trial data considered complete

2016 Year 05 Month 31 Day

Date analysis concluded

2016 Year 07 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 07 Day

Last modified on

2016 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name