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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034570
Receipt No. R000039412
Scientific Title The anti-obesity effect of luteolin-prospective study
Date of disclosure of the study information 2018/10/19
Last modified on 2019/04/20

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Basic information
Public title The anti-obesity effect of luteolin-prospective study
Acronym The anti-obesity effect of luteolin
Scientific Title The anti-obesity effect of luteolin-prospective study
Scientific Title:Acronym The anti-obesity effect of luteolin
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the anti-obesity effect of luteolin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BW,lipid,glucose,and insulin.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 luteolin intake
Interventions/Control_2 control
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
100 years-old >=
Gender Male and Female
Key inclusion criteria BMI>22,patients who attend the university of Tokyo hospital
Key exclusion criteria HD, diabetes, and cachexia.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name ATSUKO
Middle name
Last name Nakayama
Organization The university of Tokyo
Division name Department of cardilology
Zip code 113-8655
Address 7-3-1, Hongou, Bunkyou-Ku, Tokyo
TEL +81338155411
Email st7089-fki@umin.ac.jp

Public contact
Name of contact person
1st name ATSUKO
Middle name
Last name Nakayama
Organization The university of Tokyo
Division name Department of cardilology
Zip code 113-8655
Address 7-3-1, Hongou, Bunkyou-Ku, Tokyo
TEL +81338155411
Homepage URL
Email st7089-fki@umin.ac.jp

Sponsor
Institute Department of cardilology, The university of Tokyo
Institute
Department

Funding Source
Organization Tanita
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization Ethics Committee of the university of Tokyo Hospital
Address 7-3-1 Hongo
Tel +81338155411
Email st7089-fki@umin.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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 19 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
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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 19 Day
Last modified on
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039412

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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