UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058807 |
|---|---|
| Receipt number | R000067247 |
| Scientific Title | Effect of Alaska Pollack Protein (APP) intake on human skeletal muscle function: A placebo-controlled, double-blind, parallel-group comparison trial |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/15 14:11:02 |
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Basic information
Public title
Effect of Alaska Pollack Protein (APP) intake on human skeletal muscle function
Acronym
Effect of Alaska Pollack Protein (APP) intake on human skeletal muscle function
Scientific Title
Effect of Alaska Pollack Protein (APP) intake on human skeletal muscle function: A placebo-controlled, double-blind, parallel-group comparison trial
Scientific Title:Acronym
Effect of Alaska Pollack Protein (APP) intake on human skeletal muscle function: A placebo-controlled, double-blind, parallel-group comparison trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study investigates that APP intake effect of body composition and skeletal muscle function in young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Skeletal muscle function
Key secondary outcomes
Body composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the APP for 12 weeks.
Interventions/Control_2
Intake of the whey protein for 12 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1)with severe medical conditions
2)who have participated in other clinical studies, including clinical trials, within the two months prior to the start of this study
3)with food allergies (milk, eggs, wheat, soybeans, pork, chicken, gelatin) or a history of such allergies
4)with implantable devices (cardiac pacemakers, implantable cardioverter-defibrillators, cochlear implants, neurostimulators), cerebral aneurysm clips, magnetic stents, or movable artificial eyes
5)deemed ineligible for participation in this study by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Fuku |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai-City, Chiba, Japan
TEL
0476-98-1001
noriyuki.fuku@nifty.com
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Fuku |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hiraka-gakuendai, Inzai-City, Chiba, Japan
TEL
0476-98-1001
Homepage URL
noriyuki.fuku@nifty.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Nissui Corporation
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
Juntendo University Faculty and Graduate School of Health and Sports Science Research Ethics Committee
Address
1-1 Hiraka-gakuendai, Inzai-City, Chiba, Japan
Tel
0476-98-1001
sc-rinri@juntendo.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
順天堂大学スポーツ健康科学研究科・順天堂大学スポーツ健康医科学研究所
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 20 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2027 | 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 | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067247
