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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039249
Receipt No. R000044751
Scientific Title A study on the effects of application of compounded stenone cream (fermented product enriched with plant stenones) on subcutaneous fat and visceral fat.
Date of disclosure of the study information 2020/01/24
Last modified on 2020/06/10

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Basic information
Public title A study on the effects of application of compounded stenone cream (fermented product enriched with plant stenones) on subcutaneous fat and visceral fat.
Acronym A study on the effects of application of compounded stenone cream (fermented product enriched with plant stenones) on subcutaneous fat and visceral fat.
Scientific Title A study on the effects of application of compounded stenone cream (fermented product enriched with plant stenones) on subcutaneous fat and visceral fat.
Scientific Title:Acronym A study on the effects of application of compounded stenone cream (fermented product enriched with plant stenones) on subcutaneous fat and visceral fat.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to examine the effects of application of compounded stenone cream (test product) on subcutaneous fat and visceral fat in slightly obese women aged 35-64 years.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subcutaneous fat area
Key secondary outcomes Visceral fat area, Total fat area, Weight, Body fat percentage, Adiponectin, and Leptin

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 Prevention
Type of intervention
Other
Interventions/Control_1 Apply 5g of compounded stenone cream (test product) at a time once daily after leaving the bath. Continue it for 8 weeks.
Interventions/Control_2 Apply 5g of placebo at a time once daily after leaving the bath. Continue it for 8 weeks.
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
35 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria 1. 35 to 64 years old.
2. Women.
3. BMI 25.0 kg/m2 or greater.
Key exclusion criteria 1. Those are currently receiving some types of drug treatment (e.g. treatment affecting obesity, hyperlipidemia, and lipid metabolism).
2. Those who are receiving nutrition therapy or physical therapy under a doctor's supervision.
3. Those who cannot stop taking health foods or supplements (those which may affect obesity, hyperlipidemia, and lipid metabolism) during the study period.
4. Those who cannot stop drinking alcohol the day before a test.
5. Those who have a current or a past medical history of severe diseases.
6. Those who have skin diseases (e.g. atopic dermatitis) or a hypersensitivity.
7. Those who have a current or a past medical history of drug or food allergy.
8. Those who have a current or a past medical history of drug or alcohol dependence.
9. Those who have metals implanted in the body due to surgery etc.
10. Those who have a cardiac pacemaker or an implantable medical device placed in the body.
11. Those who have claustrophobia.
12. Those who work night shifts.
13. Smokers.
14. Those who are currently pregnant or breastfeeding or those who want to become pregnant during the study period.
15. Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
16. Those who were determined by the principal investigator or a sub-investigator to be an unsuitable subject for this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Nagashima
Organization DAISAN KASEI CO.,LTD.
Division name Fermentation
Zip code 290-0045
Address 50-5,Goi Minamikaigan,Ichihara-shi,Chiba
TEL 0436-22-3155
Email t-nagashima@dsk-goi.com

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL 03-6205-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

Funding Source
Organization DAISAN KASEI CO.,LTD.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Suda Clinic institutional review board
Address 2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel 03-6205-6222
Email suda-clinic_irb@imeq.co.jp

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
2020 Year 01 Month 24 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
2019 Year 12 Month 13 Day
Date of IRB
2019 Year 12 Month 25 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2020 Year 04 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 24 Day
Last modified on
2020 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044751

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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