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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020182
Receipt No. R000023095
Scientific Title The effect of milk components on cognitive functions, a randomaized controlled trial.
Date of disclosure of the study information 2015/12/14
Last modified on 2016/07/13

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Basic information
Public title The effect of milk components on cognitive functions, a randomaized controlled trial.
Acronym The effect of milk components on cognitive functions.
Scientific Title The effect of milk components on cognitive functions, a randomaized controlled trial.
Scientific Title:Acronym The effect of milk components on cognitive functions.
Region
Japan

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

Objectives
Narrative objectives1 Effects of improvement on cognitive functions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 4 month later , evaluation of cognitive functions by RBANS and Cognitrax
Key secondary outcomes SF-36 and analysis of blood

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of MFGM
Six tablets per day, once a day, 16weeks
Interventions/Control_2 Intake of milk components without MFGM
Six tablets per day, once a day, 16weeks
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
50 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) have subjective memory impairment.
2) have showed 29 or more and 52 or less in the score of RBANS
3) have showed 24 or more and 27 or less in the score of Mini Mental State Examination
Key exclusion criteria 1) Subjects who have food allergy
2) Subjects who had stroke and cerebrovascular disease
3) heavy drinker and smoker
4) Subject who have hepatitis
5) Severe anemia
6) Medications treatment
7) Subjects who have taken cognitive battery
8) Subjects who participate in other clinical study
9) Subjects who take a psychotropic medicine
10) Subjects who take a health food
11) Inadequate with physician's decision
12) Milk-intolerant
13) milk intake more than 600 ml per week
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko MASUDA
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization Kao corporation
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 12 Month 14 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 23 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 14 Day
Last modified on
2016 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023095

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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