UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034278
Receipt No. 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 (Ver. 10)

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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
Email 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
Email info@t-lab-clinic.com

Sponsor
Institute Shonan Taiyokai of Medical Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039078