Unique ID issued by UMIN | UMIN000046345 |
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Receipt number | R000052725 |
Scientific Title | A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function |
Date of disclosure of the study information | 2021/12/10 |
Last modified on | 2023/06/12 09:01:07 |
A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function
A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function
A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function
A study to evaluate the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function
Japan |
Healthy volunteers
Not applicable | Adult |
Others
NO
To examine the effects of the policosanol derived from the Cuban sugar cane on blood lipid parameters and vascular endothelial function
Efficacy
Blood analysis: LDL cholesterol
Blood analysis: HDL cholesterol, total cholesterol, Triglycerides, hsCRP, apolipoprotein A1, apolipoprotein A2, HPLC lipoprotein fraction
Vascular endothelial function: %FMD
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake of test food 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 blood LDL cholesterol levels are 120 mg/dL or more and less than 160 mg/dL
3) Subjects whose blood HDL cholesterol levels are 40 mg/dL or more
4) 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 chronic diseases (dyslipidemia, high blood pressure, diabetes, etc.)
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 effects on lipid metabolism (reducing blood LDL cholesterol, triglycerides, etc.)
5) Subjects who take foods having the effects on lipid metabolism (reducing blood LDL cholesterol, triglycerides, etc.)
6) Subjects who have a smoking habit
7) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
8) 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)
9) 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
10) Subjects deemed unsuitable by the investigator
72
1st name | Byong Ku |
Middle name | |
Last name | Lee |
RAINBOW AND NATURE KOREA CO., LTD.
CEO
137-873
Hanravivaldi Bldg, 15-10, Gangnam-daero 39-gil, Seocho-gu, Seoul
+82-2-3011-6462
bklee@rainbownature.com
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, Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc
RAINBOW AND NATURE KOREA CO., LTD.
Profit organization
IRB of Fukuda Clinic
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka, Osaka
06-6398-0203
fukudaclinicIRB@gmail.com
NO
2021 | Year | 12 | Month | 10 | Day |
Unpublished
Completed
2021 | Year | 09 | Month | 18 | Day |
2021 | Year | 09 | Month | 18 | Day |
2021 | Year | 12 | Month | 12 | Day |
2022 | Year | 05 | Month | 22 | Day |
2021 | Year | 12 | Month | 10 | Day |
2023 | Year | 06 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052725
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