Unique ID issued by UMIN | UMIN000047730 |
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Receipt number | R000054383 |
Scientific Title | A verification study of the reduction effect of body fat: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/12/12 |
Last modified on | 2023/11/02 09:37:19 |
A verification study of the reduction effect of body fat
A verification study of the reduction effect of body fat
A verification study of the reduction effect of body fat: a randomized, placebo-controlled, double-blind, parallel-group comparison study
A verification study of the reduction effect of body fat
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on body fat in healthy Japanese subjects
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The abdominal fat area
1. Body weight, body mass index (BMI), body fat percentage, muscle mass, abdominal circumference, hip circumference, thigh circumference (both legs), total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride (TG)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
2
Treatment
Food |
Duration: 12 weeks
Test food: Capsule containing plant extract
Administration: Take two capsules per day before primary meal of the day
*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
Duration: 12 weeks
Test food: Placebo capsule
Administration: Take two capsules per day before primary meal of the day
*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects whose BMI are 25 kg/m2 or more and less then 30 kg/m2 at screening (before consumption)
7. Subjects whose fasting TG level is between 120 mg/dL and 199 mg/dL
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
5. Subjects who currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, lactation, or planning to become pregnant
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
40
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Oryza Oil & Fat Chemical Co. Ltd
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2022 | Year | 12 | Month | 12 | Day |
Unpublished
44
Completed
2022 | Year | 04 | Month | 20 | Day |
2022 | Year | 04 | Month | 20 | Day |
2022 | Year | 04 | Month | 28 | Day |
2022 | Year | 11 | Month | 12 | Day |
Same target group as that of UMIN000047729
2022 | Year | 05 | Month | 12 | Day |
2023 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054383
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