Unique ID issued by UMIN | UMIN000046153 |
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Receipt number | R000052677 |
Scientific Title | A verification study of safety evaluation of excessive the test food consumption in humans: an open-label trial |
Date of disclosure of the study information | 2022/04/11 |
Last modified on | 2022/04/13 16:50:30 |
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans
A verification study of safety evaluation of excessive the test food consumption in humans: an open-label trial
A verification study of safety evaluation of excessive the test food consumption in humans
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the safety of consuming five times the recommended daily intake for four weeks in healthy Japanese subjects.
Safety
Confirmatory
Pragmatic
Not applicable
1. Incidence of side effects
2. Incidence of adverse events
1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr)
2. Physical measurement
3. Urinalysis
4. Blood test
5. The measured values and amount of change from Scr in each of the following items at four weeks after consumption (4w): visual acuity, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass*, lean body mass, muscle mass*, and body water
*Whole body, right arm, left arm, right leg, left leg, and trunk
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Duration: Four weeks
Test food: Capsule containing carotenoid
Administration: Take 14 capsules with water at any time during the day
*If you forget to take the test food, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Male or female
3. Subjects aged 20 or more
4. Healthy subjects
5. 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. Subjects 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 take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5. Subjects currently taking medicines (include herbal medicines) and supplements
6. Subjects who are allergic to medications and/or the test-food-related products (particularly gelatin)
7. Subjects who are pregnant, breast-feeding, and planning to become pregnant
8. Subjects who suffer from COVID-19
9. 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
10. Subjects who are judged as ineligible to participate in the study by the physician
11
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.
BGG Japan 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 | 04 | Month | 11 | Day |
Unpublished
12
Completed
2021 | Year | 11 | Month | 17 | Day |
2021 | Year | 11 | Month | 17 | Day |
2021 | Year | 11 | Month | 24 | Day |
2022 | Year | 03 | Month | 04 | Day |
2021 | Year | 11 | Month | 24 | Day |
2022 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052677
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