Unique ID issued by UMIN | UMIN000041242 |
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Receipt number | R000047098 |
Scientific Title | Safety confirmation test of long-term intake of Okra seed extract -open-label trial- |
Date of disclosure of the study information | 2020/09/01 |
Last modified on | 2020/12/14 09:14:08 |
Safety confirmation test of long-term intake of Okra seed extract
Safety confirmation test of long-term intake of Okra seed extract
Safety confirmation test of long-term intake of Okra seed extract -open-label trial-
Safety confirmation test of long-term intake of Okra seed extract -open-label trial-
Japan |
Healthy adult
Adult |
Others
NO
To identify the safety when intake the test foods for 12 weeks in healthy Japanese subjects
Safety
Body measurement, physical examination
Hematology test
Blood biochemistry test
Urinalysis
Doctor's questions
Assess these at screening (before intake), at 4, 8, and 12 weeks after intake
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Intake of test foods for 12 consecutive weeks (3 capsules/ day)
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Healthy adult males and females between 20 to 64 years
(2) BMI: less than 30 kg/m2
(3) Subjects who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing
(1) Subjects who were diagnosed with liver disease, kidney disease, gastrointestinal disease, heart disease, diabetes, or other diseases that may affect the results of this study, or who have a history of surgery
(2) Subjects who indicate abnormal parameter in liver or kidney function
(3) Subjects with a disease currently under treatment
(4) Subjects with anemia
(5) Subjects who detect abnormal values by blood test
(6) Subjects who determine ineligible by principal investigator
(7) Subjects with drug or food allergies
(8) Subjects who play high intensity sports and/or are on a diet
(9) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods
(10) Subjects who are under treatment with medications (including OTC or prescribed medication)
(11) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement
(12) Subjects with smoking habit
(13) Subjects with irregular life patterns and lifestyle of reversal of day and night
(14) Subjects who have a habit of excessive eating and drinking
(15) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period
(16) Subjects who is participating in the other study or planning to participate during the study period
(17) Subjects who has taken the blood sampling more than 200 mL within 1 month, or plan the blood sampling during the study period
20
1st name | Naoki |
Middle name | |
Last name | Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal Medicine
530-0044
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
06-6135-5200
tterashima@miula.co.jp
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness support Co., Ltd.
Clinical trial Division
530-0044
4F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
06-4801-8917
mterashima@oneness-sup.co.jp
Oneness support Co., Ltd.
BHN Co., Ltd.
Profit organization
Miura Clinic, Medical Corporation Kanonkai IRB
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
06-6135-5200
mterashima@oneness-sup.co.jp
NO
2020 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2020 | Year | 07 | Month | 28 | Day |
2020 | Year | 07 | Month | 30 | Day |
2020 | Year | 08 | Month | 24 | Day |
2020 | Year | 11 | Month | 20 | Day |
2020 | Year | 07 | Month | 29 | Day |
2020 | Year | 12 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047098
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