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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028585
Receipt No. R000032522
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-
Date of disclosure of the study information 2019/01/01
Last modified on 2017/08/08

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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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 19 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
2017 Year 08 Month 08 Day
Last modified on
2017 Year 08 Month 08 Day


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

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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