UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053479 |
|---|---|
| Receipt number | R000056080 |
| Scientific Title | Effect of oral intake of branched-chain amino acids in nursing mothers on the concentration of glutamic acid in breast milk - leucine as a representative substance |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/01/30 17:48:57 |
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Basic information
Public title
Effect of oral intake of branched-chain amino acids in nursing mothers on the concentration of glutamic acid in breast milk - leucine as a representative substance
Acronym
Effect of oral intake of branched-chain amino acids in nursing mothers on the concentration of glutamic acid in breast milk - leucine as a representative substance
Scientific Title
Effect of oral intake of branched-chain amino acids in nursing mothers on the concentration of glutamic acid in breast milk - leucine as a representative substance
Scientific Title:Acronym
Effect of oral intake of branched-chain amino acids in nursing mothers on the concentration of glutamic acid in breast milk - leucine as a representative substance
Region
| Japan |
Condition
Condition
Breast-feeding Woman
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of oral leucine intake on glutamate concentrations in milk and blood over time after oral leucine intake by lactating mothers.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between physical information other than maternal diet and activity level, breastfeeding and infant information, and blood and milk glutamate concentrations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glutamic acid concentration in milk
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
With oral intake of leucine
Interventions/Control_2
No oral intake of leucine
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Women between the ages of 20 and 39
Nursing mothers from 4 months to 18 months postpartum
Non-smokers
Womem who consume breakfast on a daily basis
Key exclusion criteria
Women who are allergic to the test food
Women with a history of endocrine disorders, breast disease, diabetes, dyslipidemia, cardiovascular disease, renal disease, liver disease and other diseases
Women who are prescribed any drugs that affect metabolism
Women who are currently pregnant
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Tateoka |
Organization
Shiga University of Medical Science
Division name
Division of Maternity Nursing, Department of Clinical Nursing
Zip code
5202192
Address
Setatsukinowa-cho,Otsu-shi,Shiga
TEL
0775482433
ytateoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Tate |
Organization
Shiga University of Medical Science
Division name
Division of Maternity Nursing, Department of Clinical Nursing
Zip code
5202192
Address
Setatsukinowa-cho,Otsu-shi,Shiga
TEL
0775482433
Homepage URL
ytateoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Society for Research on Umami Taste
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Setatsukinowa-cho,Otsu-shi,Shiga
Tel
0775482433
ytateoka@belle.shiga-med.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
| 2024 | Year | 01 | Month | 30 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 06 | 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
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056080
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
