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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036597
Receipt No. 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 2019/06/07

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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
Email 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
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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
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
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
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 No longer recruiting
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 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041697

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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