UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051160 |
|---|---|
| Receipt number | R000058331 |
| Scientific Title | Test the effects of peptide on recovery from fatigue and improvement of exercise function |
| Date of disclosure of the study information | 2023/05/24 |
| Last modified on | 2023/05/24 20:20:36 |
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Basic information
Public title
Fatigue recovery and exercise function improvement test
Acronym
Fatigue recovery and exercise function improvement test
Scientific Title
Test the effects of peptide on recovery from fatigue and improvement of exercise function
Scientific Title:Acronym
Test the effects of peptide on recovery from fatigue and improvement of exercise function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the effects of peptide supplementation on recovery from fatigue and improvement of exercise function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F), Survey on fatigue, Biological Antioxidant Potentia, Strength of one's back, Standing long jump, Shuttle run
Key secondary outcomes
Survey on tension and other issue, Skeletal muscle mass, Blood biochemistry test The incidence of side effects and/or adverse events
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake 5 capsules those contain test food three times a day (after each meal), for 8 weeks.
Interventions/Control_2
Intake 5 placebo capsules three times a day (after each meal), for 8 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
| 20 | years-old | <= |
Age-upper limit
| 26 | years-old | > |
Gender
Male
Key inclusion criteria
1)Males aged 20 to 25 at registration.
2) Subjects giving written informed consent.
Key exclusion criteria
1) Subjects who are regularly taking medicines or dietary supplements that may affect the results of the study.
2) Subjects with a history or current severe heart, liver, kidney or gastrointestinal disease.
3) Subjects who drink a lot of alcohol.
4) Subjects who smoke excessively.
5) Subjects with extremely irregular eating habits, irregular rhythm of life.
6) Subjects with allergies to medicines and foods (especially gelatin)
7) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
8) Subjects who have donated component blood or 200 mL of whole blood in the month prior to study entry.
9) Subjects who have donated 400 mL of whole blood in the 3 months prior to study entry.
10) Subjects who have donated 1200 mL of whole blood in the 12 months prior to study entry.
11) Subjects deemed by principal investigator to be ineligible to participate in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Shioda |
Organization
Shonan University of Medical Sciences
Division name
Faculty of Pharmaceutical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan.
TEL
045-821-0111
seiji.shioda@sums.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Hirabayashi |
Organization
Shonan University of Medical Sciences
Division name
Clinical Medicine Research Laboratory
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan.
TEL
045-821-0111
Homepage URL
takahiro.hirabayashi@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Kyodo Senpaku 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
Nippon Sport Science University, Research Review Board
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo, Japan.
Tel
03-5706-0931
souspo@nittai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
020-H161
Org. issuing International ID_1
Nippon Sport Science University, Research Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 24 | 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
35
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
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058331
