Anti-hyperlipidemic effects of 500 mg spilanthol (SA3X) supplementation in people with dyslipidemia – a randomized, parallel-group placebo-controlled trial

Abstract

Objectives Dyslipidemia is a critical risk factor for cardiovascular disease. This study investigated the impact of 500 mg of spilanthol (SA3X) supplementation on lipid profiles in men with dyslipidemia using a randomized, parallel-group, placebo-controlled design. Methods A total of 279 male participants were randomly allocated to one of four groups: SA3X without exercise, placebo without exercise, SA3X with exercise, and placebo with exercise. After a one-month control period, participants received SA3X capsules or placebo for three months. The exercise groups undertook standardized weight-lifting exercises four times weekly. Lipid profiles, biochemical parameters, and anthropometric measurements were monitored throughout and after the intervention. Results Both SA3X groups exhibited significant reductions in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) compared to the placebo groups. By day 90, the SA3X-no-exercise group showed a 16.78 % decrease in TC, while the SA3X-plus-exercise group demonstrated a 52.87 % decrease compared to placebo. Significant reductions in TG and LDL-C were noted at days 60 and 90 (p=0.01 and p=0.03, respectively). The SA3X-plus-exercise group also exhibited decreased random blood sugar levels at days 60 and 90 compared to placebo-plus-exercise. Moreover, decreases in C-reactive protein, creatine kinase, and serum creatinine levels were observed. Conclusions SA3X supplementation, particularly when combined with exercise, effectively improved lipid profiles and various health markers in men with dyslipidemia. Adverse events, primarily taste disturbance, were mild. These findings suggest SA3X may be a promising adjunctive therapy for managing dyslipidemia, emphasizing its potential cardiovascular health benefits and supporting further investigation. Trial registration CTRI/2021/05/033694; May 2021.