UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036597 |
|---|---|
| Receipt number | R000041697 |
| Scientific Title | A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin. |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2019/09/17 16:28:33 |
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Basic information
Public title
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
Acronym
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
Scientific Title
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
Scientific Title:Acronym
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Males and females (aged 20-63) who have a tendency to mild obesity take test food continuously for 12 weeks. Our aim is to examine the effects on their body compositions and skins.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area (V)
Key secondary outcomes
Subcutaneous fat area (S); V/S ratio, Weight; Body mass index (BMI); Triglycerides; Total cholesterol; High density lipoprotein cholesterol; Low density lipoprotein cholesterol; Waist circumference; Body fat percentage; Measurements of skin hydration, moisture, and elasticity
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
| Food |
Interventions/Control_1
Take 2 capsule containing wasabi leaf extract powder daily with a glass of cool or lukewarm water before sleep.
Interventions/Control_2
Take 2 placebo capsule (not containing wasabi leaf extract powder) daily with a glass of cool or lukewarm water before sleep.
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
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 20 to 63 years old.
2. Males and females.
3. BMI 23.0 to 29.9 kg/m2
4. Smartphone users (who can input their own data into the electronic diary).
5. Those who do not intend to change or do not change everyday lifestyle habits during the study period.
6. Those who can provide their written informed consent.
Key exclusion criteria
1. Those who currently receive some types of drug treatment for obesity/hyperlipidemia or a drug treatment which affects lipid metabolism (except for the drugs that are taken as needed for complications/chronic diseases)
2. Those who are receiving diet therapy or exercise therapy under the direction of a physician.
3. Those who cannot stop taking health foods or supplements during the study period.
4. Those who cannot abstain from drinking the day before a test.
5. Those with a current or a past medical history of severe disease.
6. Those with a current or a past medical history of drug or food allergy.
7. Those with a current or a past medical history of drug addiction or alcoholism.
8. Those who have a metallic object present in the body as a result of surgery or other means.
9. Those who have a cardiac pacemaker or medical device implanted in the body.
10. Those who have claustrophobia.
11. Those who work the night shift on a rotating schedule.
12. Those who want to become pregnant during the study period or those who are currently pregnant or breastfeeding.
13. Those who are participating in another clinical trial or those who had been given a test drug during another clinical trial and completed another clinical trial within a month prior to the start of this study.
14. Those who were determined by the principal investigator or a sub-investigator to be unsuitable for participation in this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Okunishi |
Organization
KINJIRUSHI Co., Ltd.
Division name
Development Division
Zip code
460-0008
Address
Nadya Park Business Center Building 23F, 3-18-1, Sakae, Naka-ku, Nagoya-shi, Aichi
TEL
052-242-0008
i-okunishi@kinjirushi.co.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yuzawa |
Organization
imeQ RD inc.
Division name
Sales department
Zip code
160-0051
Address
2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL
03-6225-6222
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
imeQ RD inc.
Institute
Department
Personal name
Funding Source
Organization
KINJIRUSHI Co., Ltd.
Organization
Division
Category of Funding Organization
Other
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
| 2019 | Year | 05 | Month | 07 | 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
12
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 | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 25 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041697
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