UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of black ginger extract on energy metabolism and sympathovagal activity
Title of the study (Brief title)	Effect of black ginger extract on energy metabolism and sympathovagal activity
Region	Japan

Condition
Condition	Healthy volunteer / adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate of effect of black ginger extract on energy metabolism and sympathovagal activity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Expired-gas Electrocardiogram
Key secondary outcomes

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1)Single oral ingestion of the test product 2)washout 3)Single oral ingestion of the control product
Interventions/Control_2	1)Single oral ingestion of the control product 2)washout 3)Single oral ingestion of the test product
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	29 years-old >=
Gender	Male
Key inclusion criteria	1. Japanese males aged 20-29 years 2. Individuals who are healthy and do not treat any disease 3. Individuals who sign the consent document after explanation of this study
Key exclusion criteria	1. Subjects with food allergies 2. Subjects who consume medicinal product which may influence the outcome of the study 3.Subjects who consume food which may influence the outcome of the study 4. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size	15

Research contact person
Name of lead principal investigator	Toshio Moritani
Organization	Kyoto University
Division name	Graduate school of human and environmental studies
Address	Yoshida, Sakyo-ku, Kyoto
TEL	075-753-6888
Email	moritani.toshio.6e@kyoto-u.ac.jp

Public contact
Name of contact person	Toshio Moritani
Organization	Kyoto University
Division name	Graduate school of human and environmental studies
Address	Yoshida, Sakyo-ku, Kyoto
TEL	075-753-6888
Homepage URL
Email	moritani.toshio.6e@kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2015 Year 10 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 20 Day
Anticipated trial start date	2015 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 10 Day
Last modified on	2017 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021942