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

• Published in: Food and chemical toxicology 2014-03, Vol.65, p.168-176
• Main Authors: Gonzales, Gustavo F., Gonzales, Carla
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Adverse effects; Biological and medical sciences; Clinical trial; Double-Blind Method; Euphorbiaceae - chemistry; Female; Helianthus; Humans; Linoleic acid; Linolenic acid; Lipid profile; Medical sciences; Placebos; Plant Oils - administration & dosage; Plant Oils - adverse effects; Plant Oils - pharmacology; Toxicity; Toxicology
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2013.12.039

•Acceptability, safety and efficacy of sacha inchi oil consumption were assessed.•Sacha inchi oil has good acceptability after one-week consumption.•Minor side-effects were observed after 4months of sacha inchi oil consumption.•Hepatic and kidney markers were not affected during 4months of sacha inchi oil consumption.•LDL-cholesterol was reduced and HDL-cholesterol was increased with sacha inchi oil consumption. The study was designed to assess acceptability and side-effects of consumption of sacha inchi oil, rich in α-linolenic acid and sunflower oil, rich in linoleic acid, in adult human subjects. Thirty subjects received 10 or 15ml daily of sacha inchi or sunflower oil for 4months. 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