Randomized double-blinded pilot clinical study of the antidiabetic activity of <i>Balanites aegyptiaca</i> and UPLC-ESI-MS/MS identification of its metabolites

<p><b>Context:</b><i>Balanites aegyptiaca</i> Del. (Zygophyllaceae) fruits are traditionally known for the treatment of hyperglycaemia. Several <i>in vitro</i> and <i>in vivo</i> studies proposed some mechanisms of action. However, clinical trials in human beings were never reported to date.</p> <p><b>Objectives</b>: To investigate the antidiabetic efficacy of the 70% ethanol extract of the pericarps of <i>B. aegyptiaca</i> (BE) within a nutritional intervention in elderly people.</p> <p><b>Materials and methods:</b> Ultra-performance electrospray ionization-mass spectroscopy (UPLC-ESI-MS/MS) analysis was used for metabolic profiling of BE which was incorporated in hard gelatine capsules (400 mg/day) and tested on 30 type 2 diabetes (T2D) Egyptian patients for 8 weeks. According to sex, age and body mass index participants were divided into two equivalent groups, placebo and treatment.</p> <p><b>Results:</b> Thirteen compounds were identified in BE using UPLC-ESI-MS/MS analysis among which five steroidal saponins, seven phenolic compounds and a sterol glucoside. At the end of the 8-week treatment, the treated group showed 26.88% decrease in 2 h postprandial plasma glucose relative to 2.6% increase in the placebo group, while fasting plasma glucose was reduced to 10.3%. Treatment with BE capsules for 8 weeks produced significant reduction in the plasma triglyceride, total cholesterol and low-density lipoprotein cholesterol by 9.0, 12.76 and 21.35%, respectively, with 29.8% increase in the high-density lipoprotein cholesterol. Plasma alanine transaminase and aspartate transaminase were reduced by 42.6 and 43.3%, respectively.</p> <p><b>Discussion and conclusion:</b> Administration of the BE capsules to T2D resulted in significant improvements in the glycaemic markers and the lipid profile, without adverse effects or hypoglycaemia.</p