UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057480 |
|---|---|
| Receipt number | R000065674 |
| Scientific Title | Amino Acid Concentration in Blood at Consumption of Test Food and Safety Confirmation Study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 14:52:39 |
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Basic information
Public title
Amino Acid Concentration in Blood at Consumption of Test Food and Safety Confirmation Study
Acronym
Amino Acid Concentration in Blood at Consumption of Test Food and Safety Confirmation Study
Scientific Title
Amino Acid Concentration in Blood at Consumption of Test Food and Safety Confirmation Study
Scientific Title:Acronym
Amino Acid Concentration in Blood at Consumption of Test Food and Safety Confirmation Study
Region
| Japan |
Condition
Condition
Health Volunteers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the absorption and safety of amino acids in the body when ingesting three test foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood amino acids
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Protein.1
Interventions/Control_2
Protein.2
Interventions/Control_3
Protein.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 and Female
Key inclusion criteria
1.Japanese men and women aged 20 to 60 years old at the time of obtaining consent
2.Those with a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 at screening
3.Those with a systolic blood pressure of less than 140 mmHg and a diastolic blood pressure of less than 90 mmHg at screening
4.Those who agree to participate in the study and can sign and date the consent form themselves
Key exclusion criteria
1.Those with a serious medical history or a history of gastrointestinal resection (excluding appendectomy and endoscopic polypectomy).
2.Those with a disease that affects excretion and digestion/absorption, or those who regularly experience indigestion, constipation, diarrhea, etc.
3.Those with significantly abnormal values in blood pressure and indices of kidney function, liver function, glucose metabolism, and lipid metabolism.
4.Those who regularly use internal medicines and supplements.
5.Those who drink a lot of alcohol (more than 60g of pure alcohol per day) and those who smoke excessively (more than 20 cigarettes per day) (including those who cannot quit smoking during the time frame of their visit or cannot maintain normal mind and body by quitting smoking).
6.Those who are taking other foods, taking medicines, or applying cosmetics or quasi-drugs, or those who are participating in an intervention study or plan to participate in another study during this study.
7.Those who have donated 400mL of blood within 6 months prior to this study.
8.Those who cannot eat any food, including the test food or the standardized diet, due to food allergies or disliked ingredients.
9.Those who may be unable to ingest ingredients in the test food whose origin is not clearly stated due to religious or other reasons.
10.Those who are otherwise deemed inappropriate to participate in this study by the principal investigator.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Teramoto |
| Middle name | |
| Last name | Sachiyuki |
Organization
FANCL
Division name
Research Institute
Zip code
244 0806
Address
12-13 Shinano, Totsuka-ku, Yokohama, Kanagawa Prefecture
TEL
09014218080
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | Tsubokawa |
| Middle name | |
| Last name | Masaya |
Organization
FANCL
Division name
clinical trial group
Zip code
244 0806
Address
12-13 Shinano, Totsuka-ku, Yokohama, Kanagawa Prefecture
TEL
09014218080
Homepage URL
tsubokawa_masaya@fancl.co.jp
Sponsor or person
Institute
FANCL
Institute
Department
Personal name
Funding Source
Organization
FANCL
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
Yamazaki Otorhinolaryngology Clinic Ethics Review Committee
Address
Kita 11-jo Nishi 14-1-16, Chuo-ku, Sapporo, Hokkaido
Tel
011-757-3387
i-takehara@kyowa-t.com
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
| 2025 | Year | 04 | 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
| 2025 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 19 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065674
