UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027340 |
|---|---|
| Receipt number | R000031266 |
| Scientific Title | Estimation of efficacy of glabridin to reduce visceral fat area |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2019/05/21 12:01:59 |
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Basic information
Public title
Estimation of efficacy of glabridin to reduce visceral fat area
Acronym
Effect of glabridin on visceral fat area
Scientific Title
Estimation of efficacy of glabridin to reduce visceral fat area
Scientific Title:Acronym
Effect of glabridin on visceral fat area
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of possibility of glabridin to prevent or improve illness due to visceral fat accumulation such as NAFLD and type II diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat area
Key secondary outcomes
body weight, body fat percentage, abdominal subcutanious fat area, abdominal total fat area, Waist circumference, hip circumference, circumference hip waist circumference ratio, CHO, LDL, HDL, triglyceride, fasting blood glucose, HbA1c, insuliin, adiponectin, AST,ALT,HOMA-R
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
glabridin soft Capsule, 100mg/day,
12 weeks.
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects are healthy 20-65 years old person
Key exclusion criteria
1.Subjects under medication.
2.Subjects taking medicine and food that might impact the outcome measures.
3.Patients with serious disease such as renal disease, heart disease, respiratory illness, internal secretion disease, diabetes
4.Subjects who has allergy to experimental diet.
5.Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
6.Subjects who has metal in the body wherethe CT scanning measurement position
7.Susbjects who has implantable meicalequipments such as pacemaker and defibrillator.
8.Subjects who has Claustrophobia.
9.Shift workers, late-night workers
10.Subjects who have been diagnosed with familial.
11.Subjects who are planning to become pregnant during the study or are pregnant or lactating.
12.Subjects who are participating or planning to participate in other clinical studies to examine effects of food, medicine or cosmetics.
13.Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Suzuki |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Medical examination and treatment management family chief director
Zip code
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3381
satoru_suzuki@sempos.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshika Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
KANEKA COPORATION
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
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
| 2017 | Year | 05 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031266
| 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 |
