Unique ID issued by UMIN | UMIN000036179 |
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Receipt number | R000041207 |
Scientific Title | Safety evaluation of excessive the test food intake in healthy subjects: a randomized, double-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2019/03/12 |
Last modified on | 2019/08/26 10:29:46 |
Safety evaluation of excessive the test food intake in healthy subjects
Safety evaluation of excessive the test food intake in healthy subjects
Safety evaluation of excessive the test food intake in healthy subjects: a randomized, double-blind, placebo-controlled, parallel-group study
Safety evaluation of excessive the test food intake in healthy subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To identify the safety of excessive consumption of the test food, the compound derived from lactic acid bacteria
Safety
Confirmatory
Pragmatic
Not applicable
1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)
*1, 3 Assess the measured value at screening (before consumption) and at 2 and 4 weeks after consumption and calculate the amount of change.
*2, 4 Assess the measured value at screening (before consumption) and at 2 and 4 weeks after consumption.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Food |
Duration: 4 weeks
Test food: The compound derived from lactic acid bacteria containing capsule
Administration: Take 20 capsules with water multiple times per day. Do not chew capsules.
* Daily dose should be taken within the day.
Duration: 4 weeks
Test food: Placebo capsule
Administration: Take 20 capsules with water multiple times per day. Do not chew capsules.
* Daily dose should be taken within the day.
20 | years-old | <= |
70 | years-old | > |
Male and Female
1. Healthy Japanese subjects who are less than 30 kg/m2 in BMI
2. Subjects who are judged as eligible to participate in the study by the physician
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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage 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 have a weak stomach or lactose intolerance
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period
10. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
40
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
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.
ASAHI CALPIS WELLNESS CO., LTD.
Profit organization
Medical Corporation Seishinkai, Takara 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
info@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)
2019 | Year | 03 | Month | 12 | Day |
Unpublished
44
Completed
2019 | Year | 02 | Month | 25 | Day |
2019 | Year | 02 | Month | 25 | Day |
2019 | Year | 03 | Month | 13 | Day |
2019 | Year | 06 | Month | 08 | Day |
2019 | Year | 03 | Month | 12 | Day |
2019 | Year | 08 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041207
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