UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058232
Receipt number R000066528
Scientific Title Effects of docosahexaenoic acid (DHA) and eicosapentaenoic acid-enriched milk beverage intake on blood DHA levels and emotion of the elderly
Date of disclosure of the study information 2025/06/20
Last modified on 2025/06/20 11:47:18

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Basic information

Public title

Effects of docosahexaenoic acid (DHA) and eicosapentaenoic acid-enriched milk beverage intake on blood DHA levels and emotion of the elderly

Acronym

Effects of docosahexaenoic acid (DHA) and eicosapentaenoic acid-enriched milk beverage intake on blood DHA levels and emotion of the elderly

Scientific Title

Effects of docosahexaenoic acid (DHA) and eicosapentaenoic acid-enriched milk beverage intake on blood DHA levels and emotion of the elderly

Scientific Title:Acronym

Effects of docosahexaenoic acid (DHA) and eicosapentaenoic acid-enriched milk beverage intake on blood DHA levels and emotion of the elderly

Region

Japan


Condition

Condition

Healthy elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of docosahexaenoic acid (DHA) and eicosapentaenoic acid-enriched milk beverage intake on blood DHA levels and emotions, and to consider the possibility of writing a paper on this and developing new DHA-fortified foods.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood DHA levels and mood after intaking a DHA/EPA-enriched milk beverage for 12 months

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

65 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Age is 65 years or older and 85 years or younger at the time of consent.
2) Cognitive function test results at the start of the study meet all of the following:
(a) total MMSE score 22 points or higher
(b) HDS-R scores 21 points or higher
3) Written informed consent to participate in the study is obtained from the individual.
4) Able to communicate in Japanese.

Key exclusion criteria

1) You have developed dementia or osteoporosis.
2) You are regularly taking antipsychotics, dementia medication, ethyl icosapentate (Epader, etc.), or omega-3 fatty acid ethyl (Lotriga).
3) You are regularly taking anticoagulants (warfarin potassium, etc.) or antiplatelet drugs (aspirin, etc.).
4) You are regularly taking supplements that are expected to improve brain function.
5) You are regularly taking DHA/EPA supplements that are expected to lower triglycerides.
6) You are regularly taking osteoporosis medication or supplements that are expected to improve bones.
7) You have the habit of consuming whole fats and oils.
8) You have a milk allergy.

Target sample size

124


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Nagai

Organization

Shimane University

Division name

Faculty of Medicine

Zip code

693-8501

Address

Enyacho 89-1, Izumo, Shimane

TEL

0853202198

Email

anagai@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Matsuzaki

Organization

Shimane University

Division name

Faculty of Medicine

Zip code

693-8501

Address

Enyacho 89-1, Izumo, Shimane

TEL

0853202114

Homepage URL


Email

matuzaki@med.shimane-u.ac.jp


Sponsor or person

Institute

Shimane University

Institute

Department

Personal name



Funding Source

Organization

Fuji Oil Holdings Inc., Japan

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

Shimane University

Address

Enyacho 89-1, Izumo, Shimane

Tel

0853202198

Email

anagai@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

2025 Year 06 Month 20 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

Preinitiation

Date of protocol fixation

2025 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2025 Year 06 Month 25 Day

Last follow-up date

2025 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Reanalysis of previously completed interventional trial data


Management information

Registered date

2025 Year 06 Month 20 Day

Last modified on

2025 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066528