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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023111
Receipt No. 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

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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
Email 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
Email n-nosaka@nisshin-oillio.com

Sponsor
Institute The Nisshin OilliO Group, Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026567

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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