UMIN-CTR Clinical Trial

Basic information
Public title	The clinical study of licorice flavonoid oil with light exercise on visceral fat reduction and safety evaluation. -Randomized, double-blind, placebo-controlled trial-
Acronym	The clinical study of licorice flavonoid oil with light exercise on visceral fat reduction and safety evaluation.
Scientific Title	The clinical study of licorice flavonoid oil with light exercise on visceral fat reduction and safety evaluation. -Randomized, double-blind, placebo-controlled trial-
Scientific Title:Acronym	The clinical study of licorice flavonoid oil with light exercise on visceral fat reduction and safety evaluation.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy of licorice flavonoid oil with light exercise on visceral fat reduction
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area This item will be measured at baseline, 8 and 12 weeks months.
Key secondary outcomes

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	Treatment
Type of intervention	Food
Interventions/Control_1	300mg/day of Licorice flavonoid oil capsule once at a day for 12 weeks
Interventions/Control_2	Light exercise(active walking twice a week and take about 8,000 step walk other five days a week)
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	1.Healthy men and women between 20 and 65 years of age 2.BMI is between 23 and 30 3.Can do active walking about 30 min twice a week and take about 8,000 step walk other 5 days a week 4.Agreed the informed concent
Key exclusion criteria	01.Under medication 02.Who can't stop to take supplements during the study 03.Who have severe disease(s) including kidney disease, heart disease, aspiration disorder, endocrine disease, diabetes, and metabolic syndrome 04.Who have an allergy to test substance 05.Drug addict and alcohol addict 06.Who have metal(s) in body around CT scan area 07.Who have in-plant medical device such as pace maker or AED 08.Feel fear to dark place (for CT scan) 09.Shift-worker, midnight-shift worker 10.Diagnosed familial hypercholesterolemia 11.Under pregnant, lactating, and potentially pregnant during the study 12.Who is attending another study using different food supplement(s), pharmaceutical(s), and cosmetic(s). Or attended/will attend another study within one month from agreed the informed consent 13.Person who is inappropriate for the study judged by medical doctor
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoya Sekiguchi
Organization	Sekiguchi Clinic
Division name	Director
Zip code
Address	5-17-27 Nekozane, Urayasu-shi, Chiba
TEL	047-306-3557
Email	scfira@royal.ocn.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshoka Komori
Organization	KSO Corporation
Division name	Sales department
Zip code
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Kaneka corporation
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	2019 Year 01 Month 01 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 07 Month 25 Day
Date of IRB	2017 Year 08 Month 04 Day
Anticipated trial start date	2017 Year 08 Month 19 Day
Last follow-up date	2018 Year 03 Month 30 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 08 Month 08 Day
Last modified on	2019 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032522