Unique ID issued by UMIN | UMIN000036031 |
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Receipt number | R000040934 |
Scientific Title | A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
Date of disclosure of the study information | 2019/03/01 |
Last modified on | 2021/02/18 14:00:49 |
A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Dose Finding Study on the Effect of Food Containing Plant Extract on Visceral Fat Area
Japan |
No
Adult |
Others
NO
To confirm the effect of food containing plant extract on visceral fat area
Efficacy
Visceral fat area
Subcutaneous fat area, Total fat area, Body weight(BMI), Waist circumference, Hip circumference, Waist circumference/ Hip circumference
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
4
Treatment
Food |
Food containing low-dose plant extract
Food containing medium-dose plant extract
Food containing high-dose plant extract
Food not containing plant extract
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1)Healthy males and females aged 20 to 64 years-old.
(2)Subjects whose BMI are 23 or over and under 30.
(3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
(1) Subjects who use habitually medications.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperglycemia, hyperlipidemia, lipid metabolism, and so on during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease).
(5) Subjects who have declared allergic reaction to ingredients of test foods.
(6) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(7) Subjects who have been implanted metal in the abdominal area, as detected by computerized tomography.
(8) Subjects who have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator).
(9) Subjects who have claustrophobia.
(10) Subjects who are shiftworker and/or midnight-shift worker.
(11) Subjects who have been diagnosed as familial hyperlipidemia.
(12) Subjects who are planning to become pregnant after imformed consent for the current study, pregnant or lactating.
(13) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(14) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
120
1st name | Naoya |
Middle name | |
Last name | Sekiguchi |
Urayasu Sekiguchi Clinic
Director
279-0004
5-17-27 Nekozane, Urayasu-shi, Chiba
047-306-3557
scfira@royal.ocn.ne.jp
1st name | Yoshika |
Middle name | |
Last name | Komori |
KSO Corporation
Sales department
105-0023
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshi@kso.co.jp
KSO Corporation
TOYO SHINYAKU Co., Ltd.
Profit organization
Ethical Committee of Nihonbashi Cardiology Clinic
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
03-5641-4133
niho-jimucho@well-sleep.jp
NO
2019 | Year | 03 | Month | 01 | Day |
Unpublished
Completed
2019 | Year | 02 | Month | 08 | Day |
2019 | Year | 02 | Month | 08 | Day |
2019 | Year | 03 | Month | 02 | Day |
2019 | Year | 07 | Month | 31 | Day |
2019 | Year | 02 | Month | 27 | Day |
2021 | Year | 02 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040934
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Research case data specifications | |
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