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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027340
Receipt No. 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

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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
Email 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
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031266

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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