UMIN-CTR Clinical Trial

Basic information
Public title	The effect of docosahexaenoic acid and eicosapentaenoic acid -enriched milk beverage ingestion on erythrocyte plasma membrane fatty acid levels of the elderly
Acronym	The effect of docosahexaenoic acid and eicosapentaenoic acid -enriched milk beverage ingestion on erythrocyte plasma membrane fatty acid levels of the elderly
Scientific Title	The effect of docosahexaenoic acid and eicosapentaenoic acid -enriched milk beverage ingestion on erythrocyte plasma membrane fatty acid levels of the elderly
Scientific Title:Acronym	The effect of docosahexaenoic acid and eicosapentaenoic acid -enriched milk beverage ingestion on erythrocyte plasma membrane fatty acid levels of the elderly
Region	Japan

Condition
Condition	The elderly
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The object is how docosahexaenoic acid and eicosapentaenoic acid -enriched milk beverage ingestion on erythrocyte plasma membrane fatty acid levels of the elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in erythrocyte membrane fatty acid composition
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Docosahexaenoic acid and eicosapentaenoic acid -enriched milk beverage
Interventions/Control_2	Placebo milk beverage
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	65 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The age at consent is 65 years old or over and 85 years old or younger. 2) The cognitive function test value at the start of the test satisfies all of the following. .total MMSE is 22 points or more .HDS-R scores is 21 points or more 3) Agreement has been obtained from the principal concerning research participation in writing. 4) Conversation in Japanese is possible.
Key exclusion criteria	1) Development of dementia and osteoporosis. 2) Use a antipsychotics, dementia treatment drugs, anticoagulants and antiplatelet drugs. 3) Taking drugs containing EPA and/or DHA, and supplements that are expected to improve brain function and to reduce serum triglyceride levels. 4) Having a habit of ingesting fats and oils as they are. 5) Having allergy to milk.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Michio Middle name Last name Hashimoto
Organization	Shimane University
Division name	Faculty of Medicine, Department of Environmental Physiology
Zip code	693-8501
Address	89-1 Enyacho, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2730
Email	michio1@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Michio Middle name Last name Hashimoto
Organization	Shimane University
Division name	Faculty of Medicine, Department of Environmental Physiology
Zip code	693-8501
Address	89-1 Enyacho, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2730
Homepage URL
Email	michio1@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	FUJI OIL HOLDINGS INC.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shimane University
Address	89-1 Enyacho, Izumo, Shimane, Japan
Tel	0853-20-2730
Email	michio1@med.shimane-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	2018 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	108
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	For patent application
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	Main results already published
Date of protocol fixation	2017 Year 11 Month 02 Day
Date of IRB	2019 Year 02 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 02 Month 01 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 13 Day
Last modified on	2021 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036204