UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034570 |
|---|---|
| Receipt number | R000039412 |
| Scientific Title | The anti-obesity effect of luteolin-prospective study |
| Date of disclosure of the study information | 2018/10/19 |
| Last modified on | 2022/04/22 09:41:16 |
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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
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
st7089-fki@umin.ac.jp
Sponsor or person
Institute
Department of cardilology, The university of Tokyo
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 19 | Day |
Last modified on
| 2022 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039412
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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