UMIN-CTR Clinical Trial

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	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
Email	ishikura@josai.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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041694