UMIN-CTR Clinical Trial

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
Last 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
1st 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