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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033385
Receipt No. R000038043
Scientific Title Effect of fish skin collagen ingestion on chronic fatigue reduction in college athletes
Date of disclosure of the study information 2018/07/25
Last modified on 2018/07/13

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Basic information
Public title Effect of fish skin collagen ingestion on chronic fatigue reduction in college athletes
Acronym Effect of fish skin collagen on chronic fatigue.
Scientific Title Effect of fish skin collagen ingestion on chronic fatigue reduction in college athletes
Scientific Title:Acronym Effect of fish skin collagen on chronic fatigue.
Region
Japan

Condition
Condition Healthy colledge student
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim of this study is to clarify whether ingestion of skin fish collagen is reduced chronical physical fatigue in colledge athlete.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oxidation Stress(d-ROMs test)
Measurment period: before collagen ingestion, 1, 2, 3 monthes after ingestion of collagen. Total mesurement time is 4th.
Key secondary outcomes Antioxidation function (BAP test)
Phychological evaluation (POMS test)

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 placebo+orange juice100ml
The ingestion is performed every morning for 3 months.
Interventions/Control_2 skin fish collagen 5g + orange juice 100ml
The ingestion is performed every morning for 3 months.
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
24 years-old >=
Gender Male
Key inclusion criteria Healthy colledge athletes
Key exclusion criteria collagen ingestion person
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka Hideto
Organization Yokohama National University
Division name Faculty of Education
Zip code
Address Hodogaya-ku Tokiwadai79-2, Yokohama Kanagawa, Japan
TEL 045-339-3277
Email tanaka-hideto-ht@ynu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tanaka Hideto
Organization Yokohama National University
Division name Faculty of Education
Zip code
Address Hodogaya-ku Tokiwadai 79-2, Yokohama Kanagawa, Japan
TEL 045-339-3277
Homepage URL
Email tanaka-hideto-ht@ynu.ac.jp

Sponsor
Institute Yokohama National University
Faculty of Education
Institute
Department

Funding Source
Organization Kojinkai
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 Month 25 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 Completed
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 13 Day
Last modified on
2018 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038043

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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