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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031699
Receipt No. R000036204
Scientific Title The effect of docosahexaenoic acid and eicosapentaenoic acid -enriched milk beverage ingestion on erythrocyte plasma membrane fatty acid levels of the elderly
Date of disclosure of the study information 2018/03/13
Last modified on 2018/03/13

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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
Middle name
Last name Michio Hashimoto
Organization Shimane University
Division name Faculty of Medicine, Department of Environmental Physiology
Zip code
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
Middle name
Last name Michio Hashimoto
Organization Shimane University
Division name Faculty of Medicine, Department of Environmental Physiology
Zip code
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
Address
Tel
Email

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 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 02 Day
Date of IRB
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
2019 Year 03 Month 31 Day

Other
Other related information

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


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

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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