In vitro and in vivo studies have shown that punicic acid, a type of conjugated fatty acid and the main constituent of pomegranate seed oil (PSO), has anti-atherogenic effects. The present study aimed at determining the effect of PSO treatment on serum lipid profiles. This double-blind placebo-controlled randomised clinical trial included fifty-one hyperlipidaemic subjects, diagnosed according to National Cholesterol Education Program definition, and randomly assigned to the PSO and the control groups. The PSO and placebo groups received 400 mg PSO and placebo twice daily, respectively and were followed up for 4 weeks. Serum concentrations of lipids and lipoproteins were measured before and 4 weeks after intervention. Mean concentration of TAG and the TAG:HDL cholesterol (HDL-C) ratio were significantly decreased after 4 weeks in the PSO group as compared with baseline values (2·75 (SD 1·40) v. 3·45 (SD 1·56) mmol/l, P¼ 0·009 and 5·7 (SD 4·6) v. 7·5 (SD 5·0), P¼ 0·031, respectively). The treatment effect was statistically significant in the PSO group as compared with controls in diminution of cholesterol:HDL-C ratio (5·4 (SD 1·5) v. 5·9 (SD 1·4), P, 0·05) adjusted for baseline values. We found a mean difference for PSO v. placebo in HDL-C concentration (0·13 v. 20·02 mmol/l) and cholesterol:HDL-C ratio (20·42 v. 0·01, P,0·05). Serum cholesterol, LDL cholesterol and glucose concentrations and body composition variables remained unchanged. It is concluded that administration of PSO for 4 weeks in hyperlipidaemic subjects had favourable effects on lipid profiles including TAG and TAG:HDL-C ratio.
Pomegranate seed oil: Hyperlipidaemia: Randomised clinical trialsNormalisation of dyslipidaemia, a modifiable risk factor, can prevent or reduce the risk of CVD, which is a leading cause of death worldwide (1,2) .In order to treat dyslipidaemia, different pharmacologic and non-pharmacologic approaches have been used. Statins are the first-line therapy for management of increased LDL cholesterol (LDL-C), despite adverse effects such as gastrointestinal symptoms and muscle aches (3) . Although fibrates may decrease serum TAG and increase serum HDL cholesterol (HDL-C), more powerful drugs for normalisation of these lipids need to be investigated.Conjugated fatty acids are well-known hypolipidaemic agents (4,5) documented for their effect on lipid metabolism (6) . PSO (Punica granatum) consists of about 80 % conjugated octadecatrienoic fatty acids, with a high content of 9-cis, 11-trans, 13-cis acid or punicic acid (PA), one of the isomers of conjugated linolenic acid (CLN) (7) ; animal studies report controversial results for the hypolipidaemic role of PSO (8,9) .Although Arao et al. (8) showed that PSO supplementation in obese hyperlipidaemic Otsuka-Long-Evans-Tokushima fatty rats reduces TAG accumulation, Yang et al. (9) demonstrated that PSO does not alter serum cholesterol concentration.Considering the lack of data on the effect of PSO on lipid profiles in human subjects, the present study investigated the effect of PSO ...