Unique ID issued by UMIN | UMIN000039632 |
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Receipt number | R000045203 |
Scientific Title | Safety evaluation of long-term intake of food containing plant extract. -a randomized, placebo-controlled, double-blind, parallel group comparison study - |
Date of disclosure of the study information | 2020/03/15 |
Last modified on | 2020/10/27 14:46:09 |
Safety evaluation
Safety evaluation
Safety evaluation of long-term intake of food containing plant extract.
-a randomized, placebo-controlled, double-blind, parallel group comparison study -
Safety evaluation of long-term intake of food containing plant extract.
-a randomized, placebo-controlled, double-blind, parallel group comparison study -
Japan |
Healthy adult
Adult |
Others
NO
To evaluate the safety of intake of food containing plant extract for 12 weeks
Safety
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 4, 8,12 weeks after intake and 4 weeks after the end of intake period and Adverse events thorough the study
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of food containing plant extract for 12 weeks
Intake of placebo for 12 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
Healthy males and females from 20 to 64 years of age
(1) Subjects who are judged as unsuitable for this study by the investigator based on the results of clinical examination or cardiopulmonary abnormality
(2) Subjects having possibilities for emerging allergy related to the study
(3) Subjects who constantly use health food richly containing involvement ingredient
(4) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(5) Subjects taking a medicine regularly
(6) Subjects who have a post crown or wear false teeth
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(9) Subjects who intend to become pregnant or lactating
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(11) Subjects who are judged as unsuitable for the study by the investigator for other reasons
40
1st name | Tomonori |
Middle name | |
Last name | Ando |
LOTTE Co., Ltd.
Central Laboratory
336-8601
3-1-1, Numakage, Minami-ku, Saitama-shi, Saitama, Japan
048-837-0187
andou_tomonori@lotte.co.jp
1st name | Yoshimi |
Middle name | |
Last name | Bansho |
TTC Co., Ltd.
Clinical Research Planning Department
150-0021
Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo, Japan
03-5459-5329
y.bansho@ttc-tokyo.co.jp
TTC Co., Ltd.
LOTTE Co., Ltd.
Profit organization
Aisei Hospital Ueno Clinic Research Ethics Committee
2-18-6, Higashiueno, Taitou-ku, Tokyo
03-6455-0880
t.saito@ttc-smo.jp
NO
2020 | Year | 03 | Month | 15 | Day |
Unpublished
Completed
2020 | Year | 02 | Month | 13 | Day |
2020 | Year | 02 | Month | 13 | Day |
2020 | Year | 03 | Month | 16 | Day |
2020 | Year | 08 | Month | 19 | Day |
2020 | Year | 02 | Month | 28 | Day |
2020 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045203
Research Plan | |
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Research case data specifications | |
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Research case data | |
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