UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057540 |
|---|---|
| Receipt number | R000065737 |
| Scientific Title | Absorption kinetics of dietary soy protein in humans |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/04/07 13:43:09 |
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Basic information
Public title
Absorption kinetics of dietary soy protein in humans
Acronym
Absorption kinetics of dietary soy protein in humans
Scientific Title
Absorption kinetics of dietary soy protein in humans
Scientific Title:Acronym
Absorption kinetics of dietary soy protein in humans
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the kinetics of absorption of undegraded peptides into the peripheral blood of healthy adult subjects by consumption of processed soybean peptide foods.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma Metabolite
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Specifics of the intervention act (2 bags of processed soy peptide food:Karada Mente Plus (12.0 g soy protein)/day, dosing period 1 day)
Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (allergic symptoms, etc.) occurs due to ingestion
Criteria for discontinuation or completion of the intervention (prophylaxis, testing, etc.); discontinuation if any intake-related discomfort (allergic symptoms, etc.) occurs
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
18 to 65 years of age
Male and female
Individuals who have given their consent
Key exclusion criteria
Individuals taking drugs related to gastrointestinal disorders (e.g. stomach pills)
Individuals with dietary protein restrictions
Individuals with food allergies (especially soy and milk allergies)
Individuals taking health supplements containing soy or protein
Individuals who refuse to participate in the study
Individuals deemed by the principal investigator to be unable to participate in the study
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
The University of Tokushima Graduate School
Division name
Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
nikawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nikawa |
Organization
The University of Tokushima Graduate School
Division name
Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9248
Homepage URL
nikawa@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School,Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Fuji Oil Group Headquarters Ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
088-615-8512
first-ec@tokushima-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
徳島大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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 | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065737
