UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031699 |
|---|---|
| Receipt number | 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 | 2021/04/15 15:12:54 |
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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 | 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
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
michio1@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036204
