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

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 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

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

Value
https://center6.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