UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031744 |
|---|---|
| Receipt number | R000036248 |
| Scientific Title | Examination of a program of dietary instructions with a national registered dietitian |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2018/03/15 17:14:03 |
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Basic information
Public title
Examination of a program of dietary instructions with a national registered dietitian
Acronym
Examination of a program of dietary instructions with a national registered dietitian
Scientific Title
Examination of a program of dietary instructions with a national registered dietitian
Scientific Title:Acronym
Examination of a program of dietary instructions with a national registered dietitian
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the relationship between dietary instructions and health challenges
Basic objectives2
Others
Basic objectives -Others
To study the relationship between dietary instructions and health challenges
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between content of meals and health conditions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Personalized dietary instruction by a national registered dietitian in 3months
Interventions/Control_2
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
-Healthy adults who have and would like to work on healthy challenges
-Males aged 30 to 60 years on the day of signing the informed consent
-Person who can operate a smartphone application LINE
-Subjects who can agree to participate in the study and provide written informed consent.
Key exclusion criteria
-Person who will be on an extended business trip in the examination period
-Person who takes medicine and supplement which may be related to fatness.
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Sakate |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
General affairs and human resources division
Zip code
Address
Grand Front Osaka B29F,3-1 Ofukacho, Kita-ku, Osaka 530-0011
TEL
06-6758-1235
sakate@rohto.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Sakate |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
General Affairs and Human Resources Division
Zip code
Address
Grand Front Osaka B29F,3-1 Ofukacho, Kita-ku, Osaka 530-0011
TEL
06-6758-1235
Homepage URL
sakate@rohto.co.jp
Sponsor or person
Institute
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 03 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | 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
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036248
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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