title: 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.
abstract: 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<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.
authors.affiliation: Department of Biological and Physiological Sciences, Faculty of Sciences and Philosophy Alberto Cazorla Tálleri, Universidad Peruana Cayetano Heredia, Lima, Peru; Insituto de Investigaciones de la Altura, Universidad Peruana Cayetano Heredia, Lima, Peru. Electronic address: Gustavo.gonzales@upch.pe.
authors.forename: Gustavo F
authors.initials: GF
authors.lastname: Gonzales
authors.affiliation: Department of Biological and Physiological Sciences, Faculty of Sciences and Philosophy Alberto Cazorla Tálleri, Universidad Peruana Cayetano Heredia, Lima, Peru; Insituto de Investigaciones de la Altura, Universidad Peruana Cayetano Heredia, Lima, Peru. Electronic address: carla.gonzales@upch.pe.
authors.forename: Carla
authors.initials: C
authors.lastname: Gonzales
mesh_terms: D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D019665:Euphorbiaceae / Q000737:chemistry*; D005260:Female; D006801:Humans; D010919:Placebos; D010938:Plant Oils / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology
chemical_list: D010919:Placebos; D010938:Plant Oils
keywords: Adverse effects; Clinical trial; Linoleic acid; Linolenic acid; Lipid profile; Toxicity