UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023111 |
|---|---|
| Receipt number | R000026567 |
| Scientific Title | Nutritional study of the dietary habit (medium-chain fatty acids) for improvement of nutritional status |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2019/05/23 10:17:39 |
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Basic information
Public title
Nutritional study of the dietary habit (medium-chain fatty acids) for improvement of nutritional status
Acronym
Nutritional study of the dietary habit (medium-chain fatty acids)
Scientific Title
Nutritional study of the dietary habit (medium-chain fatty acids) for improvement of nutritional status
Scientific Title:Acronym
Nutritional study of the dietary habit (medium-chain fatty acids)
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine the relationship between the risk of malnutrition or that of cognitive decline and the compliance of recommended healthy diet (including medium-chain triglyceride). The study was performed in a before-after trial manner for the at-home elderly of Suzuka City.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the risk of malnutrition or that of cognitive decline (serum concentrations of albumin, complement C3, apoprotein A-I, transthyretin and HDL-cholesterol, and plasma red blood cells) and the compliance of recommended diet.
Key secondary outcomes
Cognitive function screening test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
We recommend the healthy diet (including medium-chain triglyceride) for 28 days.
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons who live in Suzuka city, or persons who work in Suzuka city
2) Persons who do not frequently regular exercise (four times a week or more, for more than 30 minutes once, and more than a year)
3) Persons who do not ingest medium-chain triglyceride fortified food (five time a week or more).
Key exclusion criteria
1) Persons who have serious history, or persons who recieve the dietary instructions with life-style related diseases
2) Persons who is heavy drinker or persons who is heavy smoker or persons who have irregular diet habit
3) Persons who have serious heart or liver or kidney or blood diseases
4) Persons with certification of long-term care need
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Nosaka |
Organization
The Nisshin OilliO Group, Ltd.
Division name
Central Research Laboratory
Zip code
235-8558
Address
1 Shinmori-cho, Isogo-ku, Yokohama 235-8558, Japan
TEL
045-757-5461
n-nosaka@nisshin-oillio.com
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Nosaka |
Organization
The Nisshin OilliO Group, Ltd.
Division name
Central Research Laboratory
Zip code
235-8558
Address
1 Shinmori-cho, Isogo-ku, Yokohama 235-8558, Japan
TEL
045-757-5461
Homepage URL
n-nosaka@nisshin-oillio.com
Sponsor or person
Institute
The Nisshin OilliO Group, Ltd.
Institute
Department
Personal name
Funding Source
Organization
The Nisshin OilliO Group, 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
Shinagawa East One Med-Clinic
Address
Tokyo Minato-ku Kounan 2-16-1 Shinagawa East One Tower 3F
Tel
03-6718-2898
yuiko-ishida@irom.co.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
| 2016 | Year | 07 | Month | 12 | 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
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 24 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026567
| 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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| Registered date | File name |
