UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027675 |
|---|---|
| Receipt number | R000031700 |
| Scientific Title | A study for the influence of consumption of the ingredient which derived from milk on aging indicators |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/10/06 08:50:37 |
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Basic information
Public title
A study for the influence of consumption of the ingredient which derived from milk on aging indicators
Acronym
A study for the influence of consumption of the ingredient which derived from milk on aging indicators
Scientific Title
A study for the influence of consumption of the ingredient which derived from milk on aging indicators
Scientific Title:Acronym
A study for the influence of consumption of the ingredient which derived from milk on aging indicators
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the ingredient which derived from milk has improving effects for vascular age and appearance age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Vascular age
*Appearance age
Key secondary outcomes
*Physical functions which have availability affect vascular age
*Degree of arteriosclerosis
*Bone density
*Respiratory ability
*Blood 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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the test food 3 tablets after breakfast every day.Continuance intake of the test food for 48 weeks.
Interventions/Control_2
Intake the control food 3 tablets after breakfast every day.Continuance intake of the control food for 48 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and female who have used anti-aging dock of Ehime University Hospital and who are over 30 years old.
Key exclusion criteria
Subjects who have definite dairy products allergy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michiya |
| Middle name | |
| Last name | Igase |
Organization
Ehime University Hospital
Division name
Center for Anti-aging and Preventive Medicine
Zip code
791-0295
Address
Shitsukawa 454, Toon city, Ehime, 791-0295, Japan
TEL
089-960-5932
migase@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Igase |
| Middle name | |
| Last name | Michiya |
Organization
Ehime University Hospital
Division name
Center for Anti-aging and Preventive Medicine
Zip code
791-0295
Address
Shitsukawa 454, Toon city, Ehime, 791-0295, Japan
TEL
089-960-5932
Homepage URL
migase@m.ehime-u.ac.jp
Sponsor or person
Institute
Center for Anti-aging and Preventive Medicine, Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, 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
Institutional Review Board ,Ehime University Hospital
Address
Shitsukawa 454, Toon city, Ehime, 791-0295, Japan
Tel
089-960-5851
rinri@m.ehime-u.ac.jp
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
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
undisclosed
Publication of results
Unpublished
Result
URL related to results and publications
undisclosed
Number of participants that the trial has enrolled
100
Results
undisclosed
Results date posted
| 2019 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
undisclosed
Participant flow
undisclosed
Adverse events
undisclosed
Outcome measures
undisclosed
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 07 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031700
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
