UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036696 |
|---|---|
| Receipt number | 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 | 2020/05/21 10:08:27 |
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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
nshoko@bio.sojo-u.ac.jp
Public contact
Name of contact person
| 1st name | Ishikura |
| Middle name | |
| Last name | Keisuke |
Organization
Josai University
Division name
Department of Management, Faculty of Management
Zip code
350-0295
Address
1-1, Keyakidai, Sakado-shi, Saitama
TEL
049-271-8006
Homepage URL
ishikura@josai.ac.jp
Sponsor or person
Institute
Sojo University
Institute
Department
Personal name
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
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
15
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
| 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
| 2020 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041694
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
