UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000031266