Unique ID issued by UMIN | UMIN000047704 |
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Receipt number | R000054390 |
Scientific Title | Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/05/10 |
Last modified on | 2023/08/24 14:30:31 |
Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects
Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects
Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of 12-week consumption of the test food on fatigue and stress in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The difference in fatigue measured by VAS (visual analogue scale) before and after workload at 12 weeks after consumption (12w)
1. The fatigue measured by VAS before workload at 12w
2. The fatigue measured by VAS after workload at 12w
3. The following items of the test of the autonomic nervous system at 12w (before and after workload and the difference of them): LF (low frequency), HF (how frequency), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, TP (total power), ccvTP (coefficient of component variance TP), deviation value of autonomic function, and autonomic functional age
4. The d-ROMs (diacron reactive oxygen metabolites), BAP (biological antioxidant potential), d-ROMs/BAP ratio, and BAP/d-ROMs at 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
3
Treatment
Food |
Duration: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract (108 mg/tablet)
Administration: Take two tablets with water at any time during 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: Tablet containing ripened Korean red ginseng extract (162 mg/tablet)
Administration: Take two tablets with water at any time during 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 tablet
Administration: Take two tablets with water at any time during 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.
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects who usually feel tired or stress easily
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects whose the difference in VAS for fatigue before and after workload are large positively
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 are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome
5. Subjects whose sleeping time or habit is irregular due to working a late-night shift
6. Subjects who have physical labor such as transportation of heavy objects
7. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use
8. Subjects who currently taking medications (including herbal medicines) and supplements
9. Subjects who are allergic to medicines and/or the test food related products
10. Subjects who are pregnant, lactation, or planning to become pregnant
11. Subjects who suffer from COVID-19
12. 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
13. Subjects who are judged as ineligible to participate in the study by the physician
102
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.
KIM's Korean Ginseng 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 | 05 | Month | 10 | Day |
Unpublished
111
Completed
2022 | Year | 04 | Month | 20 | Day |
2022 | Year | 04 | Month | 20 | Day |
2022 | Year | 04 | Month | 28 | Day |
2022 | Year | 12 | Month | 21 | Day |
2022 | Year | 05 | Month | 10 | Day |
2023 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054390
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