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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026402
Receipt No. R000030329
Scientific Title validation of the effect of the intake of high calorie sausage containing salmon
Date of disclosure of the study information 2017/03/06
Last modified on 2017/09/04

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Basic information
Public title validation of the effect of the intake of high calorie sausage containing salmon
Acronym validation of the effect of the intake of high calorie sausage containing salmon
Scientific Title validation of the effect of the intake of high calorie sausage containing salmon
Scientific Title:Acronym validation of the effect of the intake of high calorie sausage containing salmon
Region
Japan

Condition
Condition verification of the antifatigue effect
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This test is intended to validate the antifatigue effects by intake of high calorie sausage containing salmon.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes push-up times
questionnaire by Jikakusho Shirabe
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 high calorie sausage containing salmon (500kcal/day, 3days)
Interventions/Control_2 control product (500kcal/day, 3days)
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
60 years-old >
Gender Male and Female
Key inclusion criteria fireman
Key exclusion criteria 1) Individuals using medical products
2) Individuals who had a habit to ingest health foods or supplements
3) Individuals who are sensitive to test
products
4) Individuals who have a history of serious
hepatopathy, kidney damage, heart disease
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Omi
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences, Sports and Exercise Nutrition
Zip code
Address 1-1-1, Tennodai, Tsukuba-city, Ibaraki, 305-8574 Japan
TEL 029-853-6319
Email omi.naomi.gn@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Omi
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences, Sports and Exercise Nutrition
Zip code
Address 1-1-1, Tennodai, Tsukuba-city, Ibaraki, 305-8574 Japan
TEL 029-853-6319
Homepage URL
Email omi.naomi.gn@u.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 03 Month 06 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 05 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
2017 Year 04 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 05 Day
Last modified on
2017 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030329

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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