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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038102
Receipt No. R000043431
Scientific Title Phase II trial for the benefit of leucine containing jelly on exercise fatigue
Date of disclosure of the study information 2019/09/26
Last modified on 2019/09/26

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Basic information
Public title Phase II trial for the benefit of leucine containing jelly on exercise fatigue
Acronym Trial for the benefit of leucine on exercise fatigue
Scientific Title Phase II trial for the benefit of leucine containing jelly on exercise fatigue
Scientific Title:Acronym Trial for the benefit of leucine on exercise fatigue
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of leucine on fatigue
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes improvement of fatigue
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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 non leucine jelly 0g
Interventions/Control_2 leucine containg jelly 2g
Interventions/Control_3 leucine containg jelly 4g
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 healthy subjects
people who have exercise habit 4 days per week
men and women
over 20 years old
Key exclusion criteria people who have been diagnosis of metabolic syndrome, disease of brain, heart, liver, kidney etc
hypertension
glucose intorerance
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Rie
Middle name
Last name Tsutsumi
Organization Tokushima University
Division name Nutrition and Metabolism
Zip code 7708503
Address 3-18-15, Kuramoto, Tokushima
TEL 088-633-7090
Email rtsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Rie
Middle name
Last name Tsutsumi
Organization Tokushima University
Division name Nutrition and Metabolism
Zip code 7708503
Address 3-18-15, Kuramoto, Tokushima
TEL 088-633-7090
Homepage URL
Email rtsutsumi@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima University
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokushima University Hospital
Address 2-50-1Kuramoto, Tokushima
Tel 088-633-3298
Email first-ec@tokushima-u.ac.jp

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
2019 Year 09 Month 26 Day

Related information
URL releasing protocol www.umin.ac.jp/ctr/
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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 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
2019 Year 09 Month 26 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043431

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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