UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059219 |
|---|---|
| Receipt number | R000067718 |
| Scientific Title | Impact of Fermented Whey Protein Intake on Plasma Amino Acid Kinetics |
| Date of disclosure of the study information | 2025/09/29 |
| Last modified on | 2025/09/29 10:18:34 |
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Basic information
Public title
Fermented Whey Protein Study
Acronym
FWP Study
Scientific Title
Impact of Fermented Whey Protein Intake on Plasma Amino Acid Kinetics
Scientific Title:Acronym
WP-AAD Study
Region
| Japan |
Condition
Condition
Not applicable: Healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the time course changes in plasma amino acid concentrations in humans after acute ingestion of fermented whey protein.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of post ingestion serum treatment on protein metabolism related responses in cultured skeletal muscle cells (C2C12), including exploratory comparisons between young and older men.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time-course changes in plasma amino acid concentrations in humans (pre-ingestion, 45, 60, 75, and 90 minutes post-ingestion).
Key secondary outcomes
Responses of C2C12 myotubes to post-ingestion serum treatment, including indices of protein synthesis and expression of signaling molecules.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Whey protein (FrieslandCampina). A single oral ingestion of 13.5 g protein dissolved in 200 mL water on one study day (once daily, one day only). The trial is conducted in a crossover design with approximately one week washout between interventions.
Interventions/Control_2
Fermented whey protein (Biotis Fermentis, FrieslandCampina). A single oral ingestion of 13.5 g protein dissolved in 200 mL water on one study day (once daily, one day only). The trial is conducted in a crossover design with approximately one week washout between interventions.
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
| 79 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males aged 18-40 years or 65-79 years
Those judged to have no health problems based on a screening examination conducted by the principal investigator or co-investigators
Individuals who have received a full explanation of the study purpose and procedures, and who have provided written informed consent
Key exclusion criteria
Individuals with milk allergy
Individuals with other food allergies
Individuals who habitually perform resistance training
Individuals who habitually consume amino acid or protein supplements
Individuals with hepatitis B or C virus infection, or suspected infection
Individuals with a history of cardiovascular disease, such as heart disease or hypertension
Individuals taking anticoagulant medications (e.g., warfarin)
Any other individuals deemed unsuitable by the principal investigator or study physician
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fujita |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Nojihigashi, Kusatsu, Shiga
TEL
077-561-5229
safujita@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Fujita |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1, Nojihigashi, Kusatsu, Shiga
TEL
077-561-5229
Homepage URL
safujita@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
FrieslandCampina
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Netherlands
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
Tel
077-599-4175
b-rinri@st.ritsumei.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
立命館大学（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 08 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067718
