UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063377 |
|---|---|
| Receipt number | R000072548 |
| Scientific Title | A pilot study on the efficacy of specific amino acid intake on hepatic fat |
| Date of disclosure of the study information | 2026/10/22 |
| Last modified on | 2026/10/22 19:43:13 |
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Basic information
Public title
A pilot study on the efficacy of specific amino acid intake on hepatic fat
Acronym
A pilot study on the efficacy of specific amino acid intake on hepatic fat
Scientific Title
A pilot study on the efficacy of specific amino acid intake on hepatic fat
Scientific Title:Acronym
A pilot study on the efficacy of specific amino acid intake on hepatic fat
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of 24-week continuous intake of specific amino acids on hepatic fat
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hepatic steatosis rate
Key secondary outcomes
AST, ALT, GGT, body weight, body fat percentage, waist circumference, FIB-4 Index, APRI, MFS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One packet of the test food dissolved in approximately 100 mL of water is consumed once daily before bedtime for 24 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Men living in or near the Kanto region and aged 40 to 60 years at the preliminary examination.
(2) Subjects who have been suspected of fatty liver disease in a health examination or imaging examination such as abdominal ultrasonography within the past year.
(3) Subjects who have not been pointed out to have metabolic dysfunction within the past year.
(4) Subjects who have not been diagnosed with alcoholic liver disease, viral hepatitis, or autoimmune hepatitis within the past year.
(5) Subjects who do not have claustrophobia and are capable of remaining still and holding breath as instructed inside narrow MRI equipment.
(6) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study.
Key exclusion criteria
(1) Subjects with inborn errors of metabolism.
(2) Subjects under follow-up observation or treatment for malignant neoplasms.
(3) Subjects with serious heart disease.
(4) Subjects with serious renal impairment.
(5) Subjects with dietary restrictions due to heart disease, liver disease, digestive disease, kidney disease, diabetes, or other illnesses.
(6) Subjects with metallic implants.
(7) Subjects with permanent makeup or tattoos judged to carry risks such as burns during MRI examination.
(8) Subjects who experienced a significant body weight change within 3 months prior to informed consent.
(9) Subjects who regularly consume pharmaceuticals, Foods for Specified Health Uses, Foods with Function Claims, or dietary supplements that may affect liver function or lipid metabolism.
(10) Subjects with irregular lifestyles, such as shift workers or night-shift workers.
(11) Subjects who participated in other clinical research, clinical trials, or human studies within 1 month prior to the start of this study.
(12) Subjects who consume excessive alcohol on a regular basis.
(13) Subjects judged to be unsuitable as subjects based on responses to the lifestyle questionnaire.
(14) Subjects otherwise judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kumie |
| Middle name | |
| Last name | Ito |
Organization
Medical Corporation Ohryokukai Nihonbashi Sakura Clinic
Division name
Department of Internal Medicine
Zip code
103-0025
Address
5F Inamura Bldg., 1-9-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo
TEL
03-6661-9061
crc_feileb@feileb.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP-DataWeave Co., Ltd.
Division name
Food Development Business Department
Zip code
162-0814
Address
Acropolis Tokyo, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
EP-DataWeave Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.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
医療法人社団桜緑会 日本橋さくらクリニック（Nihonbashi Sakura Clinic）（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 22 | 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
| 2026 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 22 | Day |
Last modified on
| 2026 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072548
