UMIN-CTR Clinical Trial

Basic information
Public title	Effect of intake of the DHA containing food on cognitive function and prevention of long-term frailty
Acronym	Effect of intake of the DHA containing food on cognitive function and prevention of long-term frailty
Scientific Title	Effect of intake of the DHA containing food on cognitive function and prevention of long-term frailty
Scientific Title:Acronym	Effect of intake of the DHA containing food on cognitive function and prevention of long-term frailty
Region	Japan

Condition
Condition	Healthy elderly subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To estimate the effect of the DHA containing food on cognitive function and prevention of long-term frailty
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MMSE, MoCA, Plasma BDNF concentration, Plasma NGF concentration, Plasma omega 3-fatty acids concentration (DHA and EPA), Plasma DHA concentration, Plasma EPA concentration, CRP concentration, Lean body mass, BMI, SMI, Subjective health status, Frequency of going out
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	24 weeks ingestion of active food
Interventions/Control_2	24 weeks ingestion of placebo food
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) Subjects giving written informed consent 2) Participants in the project for prevention of long-term frailty in Obihiro City, Hokkaido 3) Subjects aged 65 to 85 years old when consent acquisition 4) Subjects whose MMSE score is 22 points or more
Key exclusion criteria	1) Subjects who have diagnosed with dementia, malignant tumor, chronic renal failure or diabetes 2) Subjects who have significant abnormal blood test score 3) Subjects who are prescribed antipsychotics, dementia treatment drugs, ethyl icosapentaebiate or omega 3-fatty acid ethyl 4) Subjects taking supplements that are expected to improve brain function more than 4 days a week 5) Subjects taking supplements containing EPA and/or DHA more than 4 days a week 6) Subjects who are prescribed anticoagulants and antiplatelet drugs. 7) Subjects who have milk allergy or lactose intolerance 8) Subjects who have soy allergy 9) Subjects who participate in other clinical trials within the past month or have plans to participate in other clinical trials during this study period 10)Subjects who determine ineligible by the principal investigator or sub-investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Nakamura Middle name Last name Kentaro
Organization	Meiji Co., Ltd.
Division name	R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL	+81-42-632-5846
Email	kentarou.nakamura@meiji.com

Public contact
Name of contact person	1st name Yoshimura Middle name Last name Aya
Organization	Meiji Co., Ltd.
Division name	R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL	+81-42-632-5846
Homepage URL
Email	aya.yoshimura.aa@meiji.com

Sponsor
Institute	Meiji Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
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	Meiji Institutional Review Board
Address	1-29-1 Nanakuni, Hachiouji, Tokyo
Tel	+81-42-632-5900
Email	MEIJI.IRB@meiji.com

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	2021 Year 06 Month 12 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	77
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	Completed
Date of protocol fixation	2020 Year 04 Month 22 Day
Date of IRB	2020 Year 04 Month 22 Day
Anticipated trial start date	2021 Year 08 Month 18 Day
Last follow-up date	2022 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 10 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050837