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 | 2024/05/21 13:24:29 |
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
A study to examine the effects of continuous intake of wasabi leaf extract powder on body composition and the skin.
Japan |
Healthy adults
Adult |
Others
NO
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.
Safety,Efficacy
Visceral fat area (V)
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Take 2 capsule containing wasabi leaf extract powder daily with a glass of cool or lukewarm water before sleep.
Take 2 placebo capsule (not containing wasabi leaf extract powder) daily with a glass of cool or lukewarm water before sleep.
20 | years-old | <= |
64 | years-old | > |
Male and Female
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.
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.
12
1st name | Isao |
Middle name | |
Last name | Okunishi |
KINJIRUSHI Co., Ltd.
Development Division
460-0008
Nadya Park Business Center Building 23F, 3-18-1, Sakae, Naka-ku, Nagoya-shi, Aichi
052-242-0008
i-okunishi@kinjirushi.co.jp
1st name | Yoshitada |
Middle name | |
Last name | Hira |
IMEQRD Co., Ltd.
Planning and Sales Department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
clinical-trial@imeqrd.co.jp
IMEQRD Co., Ltd.
KINJIRUSHI Co., Ltd.
Other
Suda Clinic institutional review board
2-8-14, Takadanobaba, Shinjyuku, Tokyo
03-6704-5968
jimukyoku@imeqrd.co.jp
NO
2019 | Year | 05 | Month | 07 | Day |
Unpublished
12
Completed
2019 | Year | 04 | Month | 15 | Day |
2019 | Year | 04 | Month | 23 | Day |
2019 | Year | 05 | Month | 17 | Day |
2019 | Year | 08 | Month | 09 | Day |
2019 | Year | 04 | Month | 25 | Day |
2024 | Year | 05 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041697