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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018963
Receipt No. R000021942
Scientific Title Effect of black ginger extract on energy metabolism and sympathovagal activity
Date of disclosure of the study information 2015/10/19
Last modified on 2017/02/01

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Basic information
Public title Effect of black ginger extract on energy metabolism and sympathovagal activity
Acronym Effect of black ginger extract on energy metabolism and sympathovagal activity
Scientific Title Effect of black ginger extract on energy metabolism and sympathovagal activity
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshio Moritani
Organization Kyoto University
Division name Graduate school of human and environmental studies
Zip code
Address Yoshida, Sakyo-ku, Kyoto
TEL 075-753-6888
Email moritani.toshio.6e@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Moritani
Organization Kyoto University
Division name Graduate school of human and environmental studies
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 05 Month 20 Day
Date of IRB
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

Other
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

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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