Unique ID issued by UMIN | UMIN000052467 |
---|---|
Receipt number | R000059887 |
Scientific Title | Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/10/11 |
Last modified on | 2023/11/17 10:23:42 |
Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more
Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more
Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To conduct exploratory verification of the effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
1. The walking speed at 12 weeks after consumption (12w)
2. The muscle mass at 12w
1. Walking time, number of steps, stride length, walking rate (the number of steps per time), grip strength, body weight, body mass index, body fat percentage, fat mass, lean body mass, and body water 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: Lipid compounds
Administration: Take one capsule (200 mg) per day.
*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: Take one capsule (200 mg) per day.
*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 | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 40 or more
4. Healthy subjects
5. The average number of daily steps is 8000 or more per day in the last one week including the time of the agreement to participate in this trial or the average number of daily steps is 5000 or less per day in the last one week including the time of the agreement to participate in this trial
6. The bottom 52 subjects with low muscle mass among those who meet inclusion criteria No.1~5 without meeting any of exclusion criteria
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"
5. Subjects who are 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 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
9. 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.
Ezaki Glico 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 Bldg., 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 | 10 | Month | 11 | Day |
Unpublished
56
No longer recruiting
2023 | Year | 09 | Month | 20 | Day |
2023 | Year | 09 | Month | 20 | Day |
2023 | Year | 10 | Month | 11 | Day |
2024 | Year | 02 | Month | 06 | Day |
2023 | Year | 10 | Month | 11 | Day |
2023 | Year | 11 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059887
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |