UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028585 |
|---|---|
| Receipt number | 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 | 2019/09/03 11:13:37 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032522
