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KMID : 1142220190140010073
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 1 p.73 ~ p.82
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Investigation of Human Study and Clinical trial of policosanol
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Kim Hyo-Jeong
Jang Seo-Jeong
Chung Eun-Young
Jung Joo-Hee
Han Eun-Young
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Abstract
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The aim of this review article is to compare the difference between human study of health functional food and clinical trial of medicine using policosanol extracted from sugar cane. Policosanol has been classified as a health functional ingredient in Korea which has tested in human study, but policosanol has been classified as a medicine in Cuba which can directly improve blood lipid profile and tested in clinical trials. Therefore, we tried to investigate and compare the published literature on these differences. Through the literature review, we were able to compare the difference in the selection of volunteers, test conditions, efficacy and safety of the human study of health functional foods and clinical trials of medicines. The subjects of the human study were healthy volunteers and patients with borderline hyperlipidemia and dyslipidemia, and subjects of clinical trials were patients with dyslipidemia. In common, low-density lipoprotein (LDL-C), total cholesterol (TC), LDL-C/HDL-C, TC/HDL-C levels were decreased and high-density lipoprotein (HDL-C) levels were increased by policosanol. In addition, severe side effects were not reported, indicating that policosanol was safe as a health functional food and medicine. However, since studies on policosanol were mainly limited to Cuba, more reliable comparisons will be possible if policosanol study on human study and clinical trial would be performed in various countries in the future.
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KEYWORD
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Health functional ingredient, Health functional food, Policosanol, Human study, Clinical trials
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