UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034256 |
|---|---|
| Receipt number | R000039054 |
| Scientific Title | Effect for visceral fat reducing action by continuous intake of Sudachi peel extract powder: Placebo-controlled randomized double-blind, parallel-group comparison study. |
| Date of disclosure of the study information | 2018/09/26 |
| Last modified on | 2019/09/17 11:33:06 |
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Basic information
Public title
Effect for visceral fat reducing action by continuous intake of Sudachi peel extract powder: Placebo-controlled randomized double-blind, parallel-group comparison study.
Acronym
Test to reduce visceral fat at the powder of Sudachi peel extract.
Scientific Title
Effect for visceral fat reducing action by continuous intake of Sudachi peel extract powder: Placebo-controlled randomized double-blind, parallel-group comparison study.
Scientific Title:Acronym
Test to reduce visceral fat at the powder of Sudachi peel extract.
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the decrease of visceral fat reduction by capsule containing the powder of Sudachi peel extract for 12 consecutive weeks, and clarify its usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Umbilicus visceral fat area
Key secondary outcomes
･Umbilical subcutaneous fat area
･Physical examination(height, weight, body fat percentage, BMI, waist circumference)
･Blood test(TC, LDL-C, HDL-C, TG, fasting blood glucose level, HbA1c, insulin, UA)
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test-supplement for 3 months.
Interventions/Control_2
Intake of the placebo for 3 months.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Men and women older than 30 years and younger than 65 years at the date of consent.
2)Whose screening BMI is 23 kg/Square meter or more and less than 30 kg/Square meter.
3)Who can understand the contents of the study and can consent to the participation to the study after receiving the explanation.
Key exclusion criteria
1)Whose screening BMI is less than 23 kg/Square meteror 30 kg/Square meter or more.
2)Pregnant women and lactating women.
3)Who is using drug or food that principle-investigator or sub-investigator judged to affect the result of the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshimura |
Organization
Linking Setouchi Innate Immune Network
Division name
Clinical subcommittee
Zip code
761-0301
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL
087-813-9201
npolsinlsin@lsin.org
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nakamoto |
Organization
Linking Setouchi Innate Immune Network
Division name
Secretariat
Zip code
761-0301
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL
087-813-9201
Homepage URL
npolsinlsin@lsin.org
Sponsor or person
Institute
Linking Setouchi Innate Immune Network
Institute
Department
Personal name
Funding Source
Organization
Ikeda Yakusou 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
Linking Setouchi Innate Immune Network Ethics Committee
Address
Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
Tel
087-813-9201
npolsinlsin@lsin.org
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 | 09 | Month | 26 | 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
38
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
| 2018 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 14 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039054
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
