UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044496 |
|---|---|
| Receipt number | R000050837 |
| Scientific Title | Effect of intake of the DHA containing food on cognitive function and prevention of long-term frailty |
| Date of disclosure of the study information | 2021/06/12 |
| Last modified on | 2022/10/13 18:07:54 |
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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
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
aya.yoshimura.aa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050837
| Research Plan | |
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| Registered date | File name |
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