The Effect of a Supplement Containing Bergamot and Plant Sterols with or Without a Diet on Dyslipidemia: A Randomized Controlled Trial.

Dyslipidemia is a significant risk factor for cardiovascular disease. This study evaluated the efficacy of a cholesterol-lowering diet, a supplement containing bergamot and plant sterols, and their combination in managing dyslipidemia. In this 12-week randomized controlled trial, 61 adults with dyslipidemia were assigned to one of three groups: diet-only (Group D, n = 19), supplement-only (Group B, n = 21; 150 mg bergamot flavonoids + 800 mg plant sterols/day), or mixed (Group M, n = 21; Diet + Supplement). Efficacy was assessed via changes in biochemical and anthropometric parameters. The primary finding was the superior efficacy of the mixed group (Group M), which demonstrated significantly greater reductions in total cholesterol (-53.9 mg/dL; -19.8%), low-density lipoprotein cholesterol (LDL-C) (-42.6 mg/dL; -23.3%), and triglycerides (TGs) (-57.2 mg/dL; -29.7%) compared to both diet-only and supplement-only groups (P < .05). While all three groups showed improved total and LDL-C, TG levels decreased significantly only in the supplement-receiving groups (Group B and Group M). Conversely, dietary intervention primarily drove significant improvements in body weight (Group D: -4.2 kg; Group M: -3.4 kg), body mass index (-1.5 and -1.2 kg/m2, respectively), and fat mass (-3.5 and -2.9 kg, respectively). High-density lipoprotein cholesterol and liver enzymes (alanine aminotransferase, aspartate aminotransferase) remained unchanged across all groups. Combining a cholesterol-lowering diet with a bergamot and plant sterol supplement offers a synergistic and superior strategy for improving the lipid profile in individuals with dyslipidemia, while the dietary component remains essential for improving body composition.