UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034278 |
|---|---|
| Receipt number | R000039078 |
| Scientific Title | Fatigue reduction effect by fish meat peptide |
| Date of disclosure of the study information | 2018/09/26 |
| Last modified on | 2019/07/10 04:36:01 |
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Basic information
Public title
Fatigue reduction effect by fish meat peptide
Acronym
Fatigue reduction effect by fish meat peptide
Scientific Title
Fatigue reduction effect by fish meat peptide
Scientific Title:Acronym
Fatigue reduction effect by fish meat peptide
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Up to now, clinical trials using fish meat peptides have been conducted five times, and in terms of nutritional value and functionality, certain results have been achieved and no adverse events were observed. This suggests that fish meat peptides have promising functionality, but so far there has been no full-scale survey by RCT. This time, we will investigate the functionality by RCT, especially focusing on improvement of fatigue feeling.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Take 10 supplements for test, once a day (before going to bed), 12 weeks (3 months) continuously. Before and after that period, interview, blood test and acceleration pulse wave measurement are performed.
Blood test(AST,ALT,HDL,LDL,TG,TP,ALB,ALP,AMY,TB,CRE,UA,BUN)
Interview
Pulse wave
Key secondary outcomes
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
For adult subjects obtained by open recruitment, 10 supplements for tests, 10 tablets once a day (before going to bed), about 40 subjects permitted by the attending physician (of which 20 are taken as placebo tablets) , 12 weeks (3 months) Continue to take. Before and after that period, interview, blood test and acceleration pulse waves are measured, and among the functionalities of this food, especially anti-fatigue action etc. are examined.
Interventions/Control_2
For adult subjects obtained by open recruitment, 10 supplements for tests, 10 tablets once a day (before going to bed), about 40 subjects permitted by the attending physician (of which 20 are taken as placebo tablets) , 12 weeks (3 months) Continue to take. Before and after that period, interview, blood test and acceleration pulse waves are measured, and among the functionalities of this food, especially anti-fatigue action etc. are examined.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Target number: 40
Gender: Any gender does not matter
Age ranges: Adults and self-determinants
Key exclusion criteria
If it falls under A or B below, it shall be excluded from the target.
A) A person who presents the following symptoms.
1) those with chronic disease whose symptoms are not stable at the time of preliminary examination
2) Other items judged by the attending physician as inappropriate for therapeutic reasons
B) If there is an offer to cancel participation of this research regardless of the reason, that subject will be excluded from this research.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Torii |
Organization
Shonan Taiyokai of Medical Corporation
Division name
Torii Urology and Internal medicine
Zip code
236-0042
Address
Kanagawa Prefecture Yokohama City Kanazawa ku Kataya Nishi 2-21-22 Clinic Building annex
TEL
0457842002
info@t-lab-clinic.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nishikubo |
Organization
T-lab, inc.
Division name
Chairperson secretary
Zip code
2310003
Address
Kanagawa prefecture Yokohama City Nakamori 3-2-3 Kitamitsu Kaikushima Kannai Building
TEL
045-305-6862
Homepage URL
info@t-lab-clinic.com
Sponsor or person
Institute
Shonan Taiyokai of Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Suzuhiro Kamaboko 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
Torii Urology and Internal Medicine Clinical Trial Review Committee
Address
Kanagawa prefecture Yokohama City Nakamori 3-2-3 Kitamitsu Kaikushima Kannai Building
Tel
045-305-6853
irb@shonan-taiyo.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
| 2018 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
Results
There were no significant differences or trends in systolic blood pressure and blood tests other than albumin levels in this study. Moreover there was no significant difference.
Among blood pressure, peptide blood was significantly elevated in diastolic blood pressure compared with placebo, and blood albumin level tended to decrease slightly in peptide blood compared with placebo . In VAS, peptide groups were significantly reduced compared to placebo groups, and fatigue was significantly reduced.
Results date posted
| 2019 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
There was nothing in particular.
Outcome measures
Complete blood test (liver function, pancreas function, kidney function)
Autonomic nervous test
Fatigue test (VAS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039078
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