A randomized, double-blind placebo-controlled study on acceptability, safety and efficacy of oral administration of sacha inchi oil (Plukenetia volubilis L.) in adult human subjects

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• 作者：Gustavo F. Gonzales ; Carla Gonzales
• 关键词：ALA ; alpha linolenic acid ; ALP ; alkaline phosphatase ; ALT ; alanine aminotransferase ; ANOVA ; analysis of variance ; AST ; aspartate aminotransferase ; BMI ; body mass index ; CRP ; C reactive protein ; CV ; coefficient of variation ; DBP ; diastolic blood pressure ; DHA ; docosahexaenoic acid ; EDTA ; ethylenediaminetetraacetic acid ; EPA ; eicosapentaenoic acid ; GGT ; gamma glutamyl transferase ; 5-HEPE ; 5-hydroxy-eicosapentaenoic acid ; IRB ; Institutional Review Board ; LA ; linoleic acid ; LC ; long chain ; LDL chole
• 刊名：Food and Chemical Toxicology
• 出版年：March, 2014
• 年：2014
• 卷：65
• 期：Complete
• 页码：168-176
• 全文大小：862 K

文摘

The study was designed to assess acceptability and side-effects of consumption of sacha inchi oil, rich in 伪-linolenic acid and sunflower oil, rich in linoleic acid, in adult human subjects. Thirty subjects received 10 or 15 ml daily of sacha inchi or sunflower oil for 4 months. Acceptability was assessed with daily self-report and with a Likert test at the end of the study. Safety was assessed with self- recording of side-effects and with hepatic and renal markers. Primary efficacy variables were the change in lipid profile. Subjects reported low acceptability of sacha inchi oil at week-1 (37.5%). However, since week-6, acceptability was significantly increased to 81.25-93.75%. No differences were observed in acceptability with respect to sex or oil volume (P > 0.05). Most frequent adverse effects during first weeks of consuming sacha inchi oil or sunflower oil were nauseas. The side-effects were reduced with time. Biochemical markers of hepatic and kidney function were maintained unchanged. Serum total cholesterol and LDL cholesterol levels and arterial blood pressure were lowered with both oils (P < 0.05). Higher HDL-cholesterol was observed with sacha inchi oil at month-4. In conclusion, sacha inchi oil consumed has good acceptability after week-1 of consumption and it is safety.