UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020182 |
|---|---|
| Receipt number | 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 10:22:22 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023095
