UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039249 |
|---|---|
| Receipt number | 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 14:38:53 |
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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
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
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
imeQ RD inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044751
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