Unique ID issued by UMIN | UMIN000054974 |
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Receipt number | R000062732 |
Scientific Title | Effects of consumption of the test food on hemoglobin level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2024/07/18 |
Last modified on | 2024/07/19 09:03:55 |
Effects of consumption of the test food on hemoglobin level in healthy Japanese
Effects of consumption of the test food on hemoglobin level in healthy Japanese
Effects of consumption of the test food on hemoglobin level in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on hemoglobin level in healthy Japanese
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on hemoglobin level in healthy Japanese.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of hemoglobin level at 12 weeks after consumption (12w)
1. The logarithmic value of hemoglobin level at 12w
2. The measured value and logarithmic value of hemoglobin level at 6 weeks after consumption (6w)
3. The measured values and logarithmic values of the number of white blood cells, the number of red blood cells, hematocrit value, the number of platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, ferritin, and erythropoietin at 6w and 12w
4. Individuals whose responses to "vertigo," "shortness of breath or palpitation," "body lassitude," "easily tired," "coldness," "depression," "headache," "difficulty falling asleep," "loss of appetite," and "irritability" are improved by one or more levels at 6w and 12w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
YES
2
Educational,Counseling,Training
Food |
Duration: 12 weeks
Test food: Tablet containing Tetragenococcus halophilus No.1
Administration: Take one tablet with water at the breakfast once a 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: Tablet not containing Tetragenococcus halophilus No.1
Administration: Take one tablet with water at the breakfast once a 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.
18 | years-old | <= |
Not applicable |
Female
1. Japanese
2. Women
3. Adults
4. Healthy individuals
5. Individuals whose hemoglobin level is closer to 10 g/dL among those who have 10 g/dL~12 g/dL of hemoglobin level at screening (before consumption)
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are undergoing medical treatment for anemia
5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
6. Individuals who are taking or using medications (including herbal medicines) and supplements
7. Individuals who are allergic to medicines and/or the test product related products
8. Individuals who have a smoking habit
9. Individuals who are pregnant, lactating, or planning to become pregnant during this study
10. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
11. Individuals who are judged as ineligible to participate in this study by the physician
60
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.
Ichibiki 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)
2024 | Year | 07 | Month | 18 | Day |
Unpublished
Open public recruiting
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 07 | Month | 18 | Day |
2025 | Year | 04 | Month | 29 | Day |
2024 | Year | 07 | Month | 16 | Day |
2024 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062732
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