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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036696
Receipt No. R000041694
Scientific Title Effect of Taurine or Bitter Melon Extracts Supplementation on Energy Metabolism during Exercise
Date of disclosure of the study information 2019/05/17
Last modified on 2019/05/14

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Basic information
Public title Effect of Taurine or Bitter Melon Extracts Supplementation on Energy Metabolism during Exercise
Acronym Effect of Taurine or Bitter Melon Extracts Supplementation on Energy Metabolism during Exercise
Scientific Title Effect of Taurine or Bitter Melon Extracts Supplementation on Energy Metabolism during Exercise
Scientific Title:Acronym Effect of Taurine or Bitter Melon Extracts Supplementation on Energy Metabolism during Exercise
Region
Japan

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

Objectives
Narrative objectives1 To examine the effects of Taurine and Bitter Melon extract supplementation on energy metabolism during exercise just after high fat diet consumption
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Respiratory exchange ratio during exercise
Key secondary outcomes Serum concentrations of triglyceride, total cholesterol, insulin, glucagon, glucose, free fatty acids, lipid peroxide, interleukin-6, and transforming growth factor-1beta

Base
Study type Interventional

Study design
Basic design Cross-over
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 Test group 1
Duration: 1 week, 3 times a day
Test material: Taurine
Interventions/Control_2 Test group 2
Duration: 1 week, 3 times a day
Test material: Bitter Melon extract
Interventions/Control_3 Placebo group 1
Duration: 1 week, 3 times a day
Test material: Placrbo
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
30 years-old >=
Gender Male
Key inclusion criteria Healthy male university students who do not presently have habit of exercise
Subjects who understand the design of this study and provide informed consent with it.
Subjects who are over 20 years old
Key exclusion criteria Subjects who have food allergy
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Nishizono
Middle name
Last name Shoko
Organization Sojo University
Division name Department of Applied Microbial Technology, Faculty of Biotechnology and Life Science
Zip code 860-0082
Address 4-22-1, Ikeda, Nishi-ku, Kumamoto
TEL 096-326-3956
Email nshoko@bio.sojo-u.ac.jp

Public contact
Name of contact person
1st name Ishikura
Middle name
Last name Keisuke
Organization Sojo University
Division name Center for Education and Innovation
Zip code 860-0082
Address 4-22-1, Ikeda, Nishi-ku, Kumamoto
TEL 096-326-4022
Homepage URL
Email ishikura@ed.sojo-u.ac.jp

Sponsor
Institute Sojo University
Institute
Department

Funding Source
Organization Sojo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Sojo University
Address 4-22-1, Ikeda, Nishi-ku, Kumamoto
Tel 096-326-3418
Email ken-sien@ofc.sojo-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 熊本県立大学

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 17 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 04 Month 17 Day
Anticipated trial start date
2019 Year 05 Month 17 Day
Last follow-up date
2020 Year 03 Month 30 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 05 Month 09 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041694

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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