Unique ID issued by UMIN | UMIN000048119 |
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Receipt number | R000054838 |
Scientific Title | Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/06/22 |
Last modified on | 2024/04/10 09:30:24 |
Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects
Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects
Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on skeletal muscle in healthy Japanese subjects
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Lean mass at 12 weeks after consumption (12w)
Cross-sectional area of rectus abdominis muscle, cross-sectional area of abdominal oblique muscle, total cross-sectional area of rectus abdominis muscle and abdominal oblique muscle, grip strength (right hand, left hand, and both hands average), the number of times of standing up from the chair for 30 seconds, the number of times of raising upper body for 30 seconds, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass (right arm, left arm, right leg, left leg, and trunk (torso)), and muscle mass {right arm, left arm, right leg, left leg, and trunk (torso)} at 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
3
Treatment
Food | Behavior,custom |
Duration: 12 weeks
Test food: Food containing yeast extract
Administration: Dissolve one packet with water and drink it right after waking up
*If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day.
*Perform training at your home with the following content three times a week (at least one day between training days) during the test period:
(1) Squats 15 times x three sets
(2) Upper body raises 15 times x three sets
Duration: 12 weeks
Test food: Food containing whey extract
Administration: Dissolve one packet with water and drink it right after waking up
*If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day.
*Perform training at your home with the following content three times a week (at least one day between training days) during the test period:
(1) Squats 15 times x three sets
(2) Upper body raises 15 times x three sets
Duration: 12 weeks
Test food: Placebo food
Administration: Dissolve one packet with water and drink it right after waking up
*If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day.
*Perform training at your home with the following content three times a week (at least one day between training days) during the test period:
(1) Squats 15 times x three sets
(2) Upper body raises 15 times x three sets
18 | years-old | <= |
75 | years-old | > |
Male
1. Japanese
2. Men
3. Adults
4. Subjects aged less than 75
5. Healthy subjects
6. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2
7. Subjects whose lean mass are low
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 have lactose intolerance
5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
6. Subjects currently taking medicines (include herbal medicines) and supplements
7. Subjects who are allergic to medications and/or the test-food-related products (particularly milk)
8. Subjects who are pregnant, breast-feeding, and planning to become pregnant
9. Subjects who suffer from COVID-19
10. Subjects who cannot perform the specified training
11. 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
12. Subjects who are judged as ineligible to participate in the study by the physician
57
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)
2022 | Year | 06 | Month | 22 | Day |
Unpublished
63
Completed
2022 | Year | 06 | Month | 15 | Day |
2022 | Year | 06 | Month | 15 | Day |
2022 | Year | 06 | Month | 23 | Day |
2022 | Year | 12 | Month | 26 | Day |
2022 | Year | 06 | Month | 21 | Day |
2024 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054838
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