UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060976 |
|---|---|
| Receipt number | R000069776 |
| Scientific Title | An exploratory study on breast milk lipid components and their longitudinal changes |
| Date of disclosure of the study information | 2026/03/18 |
| Last modified on | 2026/03/18 18:21:03 |
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Basic information
Public title
A study of changes in breast milk lipid components after childbirth
Acronym
A substudy on breast milk lipid components within the MiNDS Study
Scientific Title
An exploratory study on breast milk lipid components and their longitudinal changes
Scientific Title:Acronym
A substudy on breast milk lipid components within the MiNDS Study
Region
| Japan |
Condition
Condition
Healthy mothers and their children
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate longitudinal changes in breast milk lipid components between 1 month and 6 months after childbirth.
Basic objectives2
Others
Basic objectives -Others
Evaluate in detail the characteristics of lipid compounds that showed longitudinal changes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate longitudinal changes in breast milk lipid components between 1 month and 6 months after childbirth.
Key secondary outcomes
Explore the effects of seasonal variation on lipid components in breast milk by two-way analysis of variance with monthly variation and seasonal variation as factors.
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Mother-infant pairs who were participants in the primary study (UMIN000050032)
2. Mother-infant pairs who delivered between 37 weeks 0 days and 41 weeks 6 days of gestation
3. Mother-infant pairs in which the infant's birth weight was 2500 g or greater
4. Mother-infant pairs who provided breast milk samples at both 1 month postpartum (30 +/- 14 days) and 6 months postpartum (180-239 days)
5. Mother-infant pairs who were practicing mixed feeding at both 1 and 6 months postpartum
6. Mother-infant pairs in which the mother's BMI was at least 18.5 and less than 25 before pregnancy and at both 1 and 6 months postpartum, at the time of breast milk collection
7. Mother-infant pairs in which the mother answered "No" to the question "Have you been diagnosed with an infectious disease as defined in Article 6 of the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases?" at the time of breast milk collection
Key exclusion criteria
1. Mother-infant pairs who expressed their intention to withdraw from participation after the public disclosure of information regarding the conduct of this study
2. Mother-infant pairs with missing data for one or more of the variables collected in this study
3. Mother-infant pairs in which the mother had a history of atopy or allergy
4. Mother-infant pairs in which the mother had mastitis at the time of breast milk collection
5. Mother-infant pairs in which the mother had nipple bleeding at the time of breast milk collection
6. Mother-infant pairs in which the mother had a smoking habit
7. Mother-infant pairs in which the interval between the date of breast milk collection and the response date for the BDHQ questionnaire (body weight entry) exceeded 2 weeks at either or both of the 1 month and 6 month postpartum assessments
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Takasugi |
Organization
Meiji Holdings Co., Ltd.
Division name
Welness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5846
satoshi.takasugi@meiji.com
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Funatsu |
Organization
Meiji Holdings Co., Ltd.
Division name
Welness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
TEL
042-632-5846
Homepage URL
yui.funatsu@meiji.com
Sponsor or person
Institute
Meiji Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo University of Agriculture and Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo, JAPAN
Tel
042-632-5900
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
| 2026 | Year | 03 | Month | 18 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 03 | 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
Observational study
Management information
Registered date
| 2026 | Year | 03 | Month | 18 | Day |
Last modified on
| 2026 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069776
