Unique ID issued by UMIN | UMIN000043126 |
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Receipt number | R000049231 |
Scientific Title | Safety evaluation for intake of Test Diet: Placebo-controlled double-blind randomized parallel study |
Date of disclosure of the study information | 2021/05/31 |
Last modified on | 2021/01/25 15:15:33 |
Safety evaluation for intake of Test Diet: Placebo-controlled double-blind randomized parallel study
Safety evaluation for intake of Test Diet
Safety evaluation for intake of Test Diet: Placebo-controlled double-blind randomized parallel study
Safety evaluation for intake of Test Diet
Japan |
healthy individuals
Adult |
Others
NO
Evaluate safety by overdose the test food to the subject.
Safety
Adverse event
Physical examination
Hematological test
Blood biochemical test
Urinalysis
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of test food for 4 weeks
Ingestion of control food for 4 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Subjects of men and women aged 20 to 64
(2) Subjects with a BMI of less than 25 kg / m2
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
(1) Persons with a history of liver disease, renal disease, digestive system disease, heart disease, diabetes, or other diseases that may affect the results of this study, or subjects with a history of surgery
(2) Subjects with abnormal liver function and renal function test values
(3) Subjects with diseases currently being treated
(4) Subjects taking warfarin
(5) Subjects with anemia symptoms (6) Subjects showing abnormal blood test values
(7) Subjects who are judged by the investigator to not participate in the study
(8) Subjects with food and drug allergies
(9) Subjects who play intense sports and subjects who are on a diet
(10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Subjects who are continuously taking medicines (including OTC and prescription medicines)
(12) Subjects who are excessively ingesting alcohol or who cannot stop drinking from the day before the test to the day of the test (13) Subjects with smoking habits (14) Subjects with an irregular lifestyle and a lifestyle that reverses day and night (15) Subjects who have a habit of drinking and eating (16) Subjects who are pregnant or plan to become pregnant or breastfeed during the study period (female only) (17) Subjects who are participating in or will participate in other clinical trials at the start of this study. (18) Subjects who donated 200 mL or more of blood from the month before the start of the test to the start of the test, or those who are scheduled to do so during the test period
30
1st name | Naoki |
Middle name | |
Last name | Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal medicine
530-0044
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
info@miura-cl.jp
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness Support Co., Ltd.
Clinical Trial Division
530-0044
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-4801-8917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
euglena Co.,Ltd.
Profit organization
Miura Clinic, Medical Corporation Kanonkai IRB
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
mterashima@miura-cl.jp
NO
医療法人花音会みうらクリニック(大阪府) Miura Clinic, Medical Corporation Kanonkai(Osaka)
2021 | Year | 05 | Month | 31 | Day |
Unpublished
Preinitiation
2020 | Year | 12 | Month | 24 | Day |
2020 | Year | 12 | Month | 24 | Day |
2021 | Year | 01 | Month | 27 | Day |
2021 | Year | 05 | Month | 31 | Day |
2021 | Year | 01 | Month | 25 | Day |
2021 | Year | 01 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049231
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