UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057823 |
|---|---|
| Receipt number | R000066095 |
| Scientific Title | A prospective observational study on the effect of D-alanine intake on amino acid metabolism in adult women |
| Date of disclosure of the study information | 2026/05/09 |
| Last modified on | 2025/05/09 23:15:14 |
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Basic information
Public title
A prospective observational study on the effect of D-alanine intake on amino acid metabolism in adult women
Acronym
D-alanine intake study in healthy adult women
Scientific Title
A prospective observational study on the effect of D-alanine intake on amino acid metabolism in adult women
Scientific Title:Acronym
D-alanine intake study in healthy adult women
Region
| Japan |
Condition
Condition
Age-related diseases
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of D-alanine intake on amino acid metabolism in healthy adult women
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in blood and urinary DL-amino acids six weeks after starting D-alanine intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of 1g of D-alanine per day for 6 weeks
Interventions/Control_2
Oral intake of 1g of placebo per day for 6 weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The subjects must meet all of the following criteria:
1) Those who are 18 years of age or older at the time of obtaining consent
2) Those who have given written informed consent to participate in this study
Key exclusion criteria
Those who meet any of the following criteria will be excluded.
1) Those who are currently visiting a hospital and taking medication
2) Those who are deemed inappropriate to be subjects by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sakuta |
Organization
SHOWA WOMEN'S UNIVERSITY
Division name
Department of Health Sciences
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
TEL
+81-3-3411-7401
t-sakuta@swu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sakuta |
Organization
SHOWA WOMEN'S UNIVERSITY
Division name
Department of Health Sciences
Zip code
154-8533
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
TEL
+81-3-3411-7401
Homepage URL
t-sakuta@swu.ac.jp
Sponsor or person
Institute
SHOWA WOMEN'S UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
KAGAMI INC.
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
SHOWA WOMEN'S UNIVERSITY
Address
1-7-57 Taishido, Setagaya-ku, Tokyo
Tel
+81-3-3411-7351
kenkyu@swu.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
| 2026 | Year | 05 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 10 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066095
