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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018810
Receipt No. R000021422
Scientific Title Effects of ginger extract on energy metabolism
Date of disclosure of the study information 2015/09/01
Last modified on 2019/08/22

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Basic information
Public title Effects of ginger extract on energy metabolism
Acronym Effects of ginger extract on energy metabolism
Scientific Title Effects of ginger extract on energy metabolism
Scientific Title:Acronym Effects of ginger extract on energy metabolism
Region
Japan

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

Objectives
Narrative objectives1 To improve obesity by increasing energy metabolism through skeletal muscle hypermetabolism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle energy metabolism related gene expression
Key secondary outcomes Body weight

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ginger extract-containing capsule
300 mg/day, 2 weeks
Interventions/Control_2 Placebo capsule
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
60 years-old >
Gender Male
Key inclusion criteria Healthy adult males
Key exclusion criteria 1. Subjects whose BMI is 30 or more, or less than 18.5
2. Subjects who take continuous medical treatment
3. Subjects suffering from serious disease
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Shimotoyodome
Organization Kao Corporation
Division name Biological Science Research
Zip code 3213497
Address 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi
TEL 0285-68-7589
Email shimotoyodome.akira@kao.co.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Misawa
Organization Kao Corporation
Division name Biological Science Research
Zip code 3213497
Address 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi
TEL 0285-68-7643
Homepage URL
Email misawa.koichi@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Human Research Ethics Committee of Biological Science Laboratories of Kao Corporation
Address 2606, Akabane,Ichikai-Machi,Haga-Gun,Tochigi 321-3497,Japan
Tel 0285-68-7589
Email 304468@kao.co.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

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 10
Results
Significant difference in the primary outcome
Results date posted
2019 Year 08 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy men, 20 to 59 years old
Participant flow
10 participants completed and 10 subjects were incorporated into the analyses
Adverse events
none
Outcome measures
Changes in gene expression related to energy metabolism in skeletal muscle
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 04 Month 18 Day
Date of IRB
2013 Year 04 Month 18 Day
Anticipated trial start date
2013 Year 04 Month 18 Day
Last follow-up date
2013 Year 06 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 26 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021422

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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