UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057268 |
|---|---|
| Receipt number | R000065374 |
| Scientific Title | Effects of docosahexaenoic acid and eicosapentaenoic acid enriched milk beverage consumption on emotion and intestinal microbiota in Minors |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2025/03/12 03:10:41 |
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Basic information
Public title
Effects of docosahexaenoic acid and eicosapentaenoic acid enriched milk beverage consumption on emotion and intestinal microbiota in Minors
Acronym
Effects of docosahexaenoic acid and eicosapentaenoic acid enriched milk beverage consumption on emotion and intestinal microbiota in Minors
Scientific Title
Effects of docosahexaenoic acid and eicosapentaenoic acid enriched milk beverage consumption on emotion and intestinal microbiota in Minors
Scientific Title:Acronym
Effects of docosahexaenoic acid and eicosapentaenoic acid enriched milk beverage consumption on emotion and intestinal microbiota in Minors
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of DHA and EPA -enriched milk beverage ingestion on emotion and intestinal microbiota in miners.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effects of DHA and EPA -enriched milk beverage ingestion on emotion
Key secondary outcomes
1) The effects of DHA and EPA -enriched milk beverage ingestion on intestinal microbiome
2) The effects of DHA and EPA -enriched milk beverage ingestion on omega-3 Index
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
DHA and EPA-enriched milk beverage
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
| 9 | years-old | < |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The age at consent is 9-15years old
2) Be attending school at consent
Key exclusion criteria
1) Having allergy to milk
2) Use a antipsychotics drug
3) Use ethyl icosapentate (e.g., Epadel) or ethyl omega-3 fatty acid (Lotriga)
4) Taking supplements that is expected to improve brain function
5) Having a habit of ingesting fats and oils as they are.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shuzo |
| Middle name | |
| Last name | Ohata |
Organization
Kato Hospital, Jinjukai Healthcare Corporation
Division name
President
Zip code
696-0001
Address
Kawamoto 383-1, Kawamoto, Shimane, Japan
TEL
0855-72-3220
zou@k-jinju.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ichinose |
Organization
FUJI OIL CO., LTD.
Division name
Research Institute for Creating the future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai-shi, Ibaraki 300-2497, Japan
TEL
0297-52-6325
Homepage URL
ichinose.takashi@so.fujioil.co.jp
Sponsor or person
Institute
Kato Hospital, Jinjukai Healthcare Corporation
Institute
Department
Personal name
Funding Source
Organization
FUJI OIL 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
Kato Hospital, Jinjukai Healthcare Corporation
Address
Kawamoto 383-1, Kawamoto, Shimane, Japan
Tel
0855-72-3220
osa-t@k-jinju.or.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 | 03 | Month | 12 | 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
90
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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065374
