Unique ID issued by UMIN | UMIN000037518 |
---|---|
Receipt number | R000042773 |
Scientific Title | A study of excessive intake of the food containing plant-derived ingredient. (SME-2019-02-FOSHUS) |
Date of disclosure of the study information | 2019/07/29 |
Last modified on | 2020/11/05 10:23:01 |
A study of excessive intake of the food containing plant-derived ingredient.
(SME-2019-02-FOSHUS)
A study of excessive intake of the food containing plant-derived ingredient.
A study of excessive intake of the food containing plant-derived ingredient.
(SME-2019-02-FOSHUS)
A study of excessive intake of the food containing plant-derived ingredient.
Japan |
Not applicable
Not applicable | Adult |
Others
NO
To evaluate the safety of food
Safety
Expression rate of side effects
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Four weeks repeated intake of the test foods
Four weeks repeated intake of the control foods
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1)Healthy male and female whose age are 20 <= years old <65.
(2)Subjects who are able to visit
medical institution on the stipulated date.
(3)Subjects who are able to submit the written informed consents.
(1) Subjects who are with treatment.
(2) Subjects whose systolic pressure <90 mmHg.
(3) Females in pregnancy,lactation and scheduled pregnancy period.
(4) Subjects who donated over 200ml blood components or whole blood within 4 weeks.
(5) Male Subjects who donated over 400ml whole blood within 12 weeks.
(6) Female who donated over 400ml whole blood within 16 weeks.
(7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
(8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
(9) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
(10) Subjects who are;
(a)With present heart disorder,liver disorder,or kidney disorder.
(b)With history of cardiac disorder.
(c)With diabetes mellitus.
(d)With allergy to drugs or foods.
(e)With glaucoma.
(f)With hyponatremia.
(11) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
(12) Subjects who drink alcohol or smoke a lot.
(13) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift.
(14) Subjects who themselves or family living together work at a company that plans, researches, develops, manufactures or sells supplements and/or functional foods (including Food for Specified Health Uses).
(15) Subjects who are deemed to be unsuitable by the investigator.
48
1st name | Hidenori |
Middle name | |
Last name | Obata |
Suntory MONOZUKURI Expert Limited
R&D Support Department, HE Center
135-8631
2-3-3 Daiba, Minato-ku, Tokyo, Japan
03-5579-1277
Hidenori_Obata@suntory.co.jp
1st name | Keisuke |
Middle name | |
Last name | Yasumoto |
Suntory MONOZUKURI Expert Limited
R&D Support Department, HE Center
619-0284
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
0774-66-1110
Keisuke_Yasumoto@suntory.co.jp
Suntory MONOZUKURI Expert Limited
Suntory Beverage & Food Limited
Profit organization
Institutional Review Board of Takara Clinic
2-3-2 Higashigotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
info@takara-clinic.com
NO
2019 | Year | 07 | Month | 29 | Day |
Unpublished
Completed
2019 | Year | 07 | Month | 29 | Day |
2019 | Year | 07 | Month | 29 | Day |
2019 | Year | 07 | Month | 30 | Day |
2019 | Year | 12 | Month | 15 | Day |
2019 | Year | 07 | Month | 29 | Day |
2020 | Year | 11 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042773