Unique ID issued by UMIN | UMIN000050371 |
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Receipt number | R000057350 |
Scientific Title | Effects of consumption of the food containing lactic acid bacteria on muscle and body fat in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/02/22 |
Last modified on | 2024/04/16 09:18:04 |
Effects of consumption of the test food on muscle and body fat in healthy Japanese subjects
Effects of consumption of the test food on muscle and body fat in healthy Japanese subjects
Effects of consumption of the food containing lactic acid bacteria on muscle and body fat in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the food containing lactic acid bacteria on muscle and body fat in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on muscle mass and body fat mass in healthy middle-age subjects
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Lean body mass at 12 weeks after consumption (12w)
The visceral fat area, subcutaneous fat area, total fat area, body weight, body mass index (BMI), body fat percentage, fat mass (whole body, right leg, left leg, right arm, left arm, and trunk), muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), and abdominal circumference at 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
Duration: 12 weeks
Test food: Capsule containing killed-Lactobacillus plantarum TWK10 powder
Administration: Tale one capsule with water at any time once daily
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks
Test food: Placebo capsule
Administration: Tale one capsule with water at any time once daily
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
40 | years-old | <= |
64 | years-old | >= |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 20 or above and 64 or below
4. Healthy subjects
5. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2
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 currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are 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, lactating, or planning to become pregnant during this trial
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 this study by the physician
52
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.
Nakahara 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)
2023 | Year | 02 | Month | 22 | Day |
Unpublished
56
Completed
2023 | Year | 02 | Month | 15 | Day |
2023 | Year | 02 | Month | 15 | Day |
2023 | Year | 02 | Month | 24 | Day |
2023 | Year | 08 | Month | 10 | Day |
2023 | Year | 02 | Month | 17 | Day |
2024 | Year | 04 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057350
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