Unique ID issued by UMIN | UMIN000044759 |
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Receipt number | R000050978 |
Scientific Title | A dose-ranging study to evaluate the effects of plant extract on reducing serum triglyceride levels |
Date of disclosure of the study information | 2021/07/05 |
Last modified on | 2022/06/10 10:13:58 |
A dose-ranging study to evaluate the effects of plant extract on reducing serum triglyceride levels
A dose-ranging study to evaluate the effects of plant extract on reducing serum triglyceride levels
A dose-ranging study to evaluate the effects of plant extract on reducing serum triglyceride levels
A dose-ranging study to evaluate the effects of plant extract on reducing serum triglyceride levels
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To examine an effective dose of plant extract on reducing serum triglyceride levels
Efficacy
Serum triglyceride levels
Body fat percentage, Body fat mass, Weight, BMI
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Intake of test food contained 100 mg of plant extract for 12 weeks
Intake of test food contained 200 mg of plant extract for 12 weeks
Intake of placebo for 12 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Males and females whose age of 20 years or more and less than 65 years
2) Subjects whose serum triglyceride levels are 120 mg/dL or more and 199 mg/dL or less at the screening examination
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
1) Subjects receiving a medical treatment for dyslipidemia
2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
3) Subjects who have the possibility of developing allergic symptoms by the test food
4) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the functions related to lipid metabolism (triglyceride reduction, LDL cholesterol reduction, etc)
5) Subjects who take foods having the effects related to lipid metabolism (triglyceride reduction, LDL cholesterol reduction, etc)
6) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
7) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
8) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
9) Subjects deemed unsuitable by the investigator
72
1st name | Mamiko |
Middle name | |
Last name | Kohno |
Morishita Jintan Co.,Ltd
Health Care Product Department
573-0128
2-11-1, Tsudayamate, Hirakata-shi, Osaka
072-800-1044
m_kohno@jintan.co.jp
1st name | Tomohiro |
Middle name | |
Last name | Sugino |
Soiken Inc.
R&D Division
560-0082
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc.
Morishita Jintan Co.,Ltd
Profit organization
IRB of Fukuda Clinic
Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
06-6398-0203
fukudaclinicIRB@gmail.com
NO
2021 | Year | 07 | Month | 05 | Day |
Unpublished
72
Completed
2021 | Year | 06 | Month | 19 | Day |
2021 | Year | 06 | Month | 19 | Day |
2021 | Year | 08 | Month | 08 | Day |
2021 | Year | 11 | Month | 29 | Day |
2021 | Year | 07 | Month | 05 | Day |
2022 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050978
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Research case data specifications | |
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