Unique ID issued by UMIN | UMIN000025414 |
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Receipt number | R000029256 |
Scientific Title | Safety evaluation of an excessive consumption of Bilberry extract and Lutein |
Date of disclosure of the study information | 2016/12/26 |
Last modified on | 2017/12/28 16:48:48 |
Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Japan |
Nothing (healthy subject)
Adult |
Others
NO
To evaluate the safety of excessive consumption of Bilberry extract and Lutein
Safety
Hematologic test (0w,2w,4w,6w)
Body measurement(0w,6w)
Blood biochemical test (0w,2w,4w,6w)
Urine analysis (0w,2w,4w,6w)
Doctor's questions (0w,6w)
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Food |
Bilberry extract 240mg and Lutein 120mg,4weeks
20 | years-old | <= |
60 | years-old | > |
Male and Female
1. Healthy Japanese males and females
2. BMI>=18.5 and <25 kg/m2
1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who are patient or have history of cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Subjects who have undergone gastrointestinal tract surgery; except appendectomy
4. Subjects who are currently taking medicines (include herbal medicines) and/or supplements
5. Subjects who are allergic to medicines or the test material of this trial
6. Subjects who are or are possibly pregnant, or are lactating
7. Subjects who participate in other clinical trials in the past 3 months
8. Subjects who work time is irregular
9. Subjects who have been determined ineligible by principal investigator for other reasons
20
1st name | |
Middle name | |
Last name | Marie Kosehira |
Omnica Co.,Ltd
Research and development Dept.
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
03-5840-9811
kosehira@omnica.co.jp
1st name | |
Middle name | |
Last name | Marie Kosehira |
Omnica Co.,Ltd
Research and development Dept.
TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
03-5840-9811
kosehira@omnica.co.jp
Omnica Co.,Ltd
Omnica Co.,Ltd
Profit organization
NO
医療法人財団 百葉の会 銀座医院(東京)
2016 | Year | 12 | Month | 26 | Day |
Unpublished
Completed
2016 | Year | 12 | Month | 22 | Day |
2016 | Year | 12 | Month | 26 | Day |
2016 | Year | 12 | Month | 26 | Day |
2017 | Year | 12 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029256
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Research case data | |
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