UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051466 |
|---|---|
| Receipt number | R000058650 |
| Scientific Title | Prospective observational study of the effects of D-alanine intake on amino acid metabolism |
| Date of disclosure of the study information | 2023/06/28 |
| Last modified on | 2024/06/04 15:43:36 |
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Basic information
Public title
Prospective observational study of the effects of D-alanine intake on amino acid metabolism
Acronym
D-alanine intake studies in healthy adults
Scientific Title
Prospective observational study of the effects of D-alanine intake on amino acid metabolism
Scientific Title:Acronym
D-alanine intake studies in healthy adults
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of D-alanine intake on amino acid metabolism in healthy adults
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in serum and urine DL-amino acids at 7 days after D-alanine intake initiation
Key secondary outcomes
1) Changes at 7 days after D-alanine intake initiation; blood glucose, HbA1c, blood pressure, body mass index (BMI), estimated GFR, urine protein/creatinine ratio, urine beta2-microglobulin, urine N-acetyl-beta-D-glucosaminidase
2) Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of D-alanine 3 g per day for 7 days
Interventions/Control_2
Oral intake of D-alanine 6 g per day for 7 days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons are included if they meet all of the following criteria;
1) Aged 20 years or over
2) Agree to participate in this study
Key exclusion criteria
Persons are excluded if they meet any of the following criteria;
1) Pregnant or lactating
2) Judged by physicians to be unsuitable as participants
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Oshima |
Organization
Kanazawa University
Division name
Department of Nephrology and Laboratory Medicine
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
+81-76-265-2499
moshima@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Oshima |
Organization
Kanazawa University
Division name
Department of Nephrology and Laboratory Medicine
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
+81-76-265-2499
Homepage URL
moshima@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Megumi Oshima
Funding Source
Organization
Self-founding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Koryo clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
Tel
+81-76-265-2499
moshima@staff.kanazawa-u.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
金沢大学附属病院（石川県）、高陵クリニック（富山県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.cdnut.2024.103787
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.cdnut.2024.103787
Number of participants that the trial has enrolled
24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 22 | Day |
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
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058650
