UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053769 |
|---|---|
| Receipt number | R000061363 |
| Scientific Title | Exploratory study of test food on postprandial serum metabolite level |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2024/03/04 10:38:29 |
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Basic information
Public title
Exploratory study of test food on postprandial serum metabolite level
Acronym
Exploratory study of test food on postprandial serum metabolite level
Scientific Title
Exploratory study of test food on postprandial serum metabolite level
Scientific Title:Acronym
Exploratory study of test food on postprandial serum metabolite level
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the transfer metabolites into the blood by eating test food
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of amino acids metabolites in blood
Key secondary outcomes
Concentration of free amino acids and lactic acid in blood
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
Single ingestion of test food
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Male subjects ranging age from 20 to 59
(2) Subjects who can ingest 100g test food
(3) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who are now under medication treatment or will take medication on the test day
(2) Subjects who are now under other clinical trials with some kind of medicine/food, or participated in those tests within four weeks before this trial, or planning to join those after the consent.
(3) Subjects who regularly consume large amount of alcohol
(4) Subjects with a history of gastrointestinal surgery
(5) Subjects who have been diagnosed with gastroptosis or esophagitis
(6) Subjects who have tested positive for HBs antigen, HCV antibody, HIV, or syphilis in the past
(7) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney, digestive system, etc.
(8) Subjects whose protein intake is restricted under the supervision of a doctor
(9) Subjects who are aware of lactose intolerance
(10) Subjects who are allergic to foods or pharmaceuticals.
(11) Subjects who donated their blood components and/or whole blood (200 mL) within a month prior to this trial.
(12) Subjects who donated their whole blood (400 mL) within the last three months prior to this trial.
(13) Subjects who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kawai |
Organization
Meiji Co., Ltd.
Division name
Food Science&Technology Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5810
yoshitaka.kawai@meiji.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku,Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | 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
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2024 | 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 | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061363
