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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034256
Receipt No. 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 2018/09/28

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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
Middle name
Last name Hiroshi Yoshimura
Organization Linking Setouchi Innate Immune Network
Division name Clinical subcommittee
Zip code
Address Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL 087-813-9201
Email npolsinlsin@lsin.org

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Nakamoto
Organization Linking Setouchi Innate Immune Network
Division name Secretariat
Zip code
Address Kagawa prefecture 2217-16 Takamatsu Shi Hayashi cho FROM Kagawa 3rd floor biotechnology laboratory
TEL 087-813-9201
Homepage URL
Email npolsinlsin@lsin.org

Sponsor
Institute Linking Setouchi Innate Immune Network
Institute
Department

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
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
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
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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 28 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
2018 Year 09 Month 25 Day
Last modified on
2018 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039054

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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