The effects of a novel nutraceutical combination on low-density lipoprotein cholesterol and other markers of cardiometabolic health in adults with hypercholesterolaemia: A randomised double-blind placebo-controlled trial

Abstract

Background and aim: Clinical evidence exists for LDL-cholesterol lowering by plant sterols, bergamot extract and artichoke leaf extract individually but their effect when combined is unknown. This study investigated the effects of a novel nutraceutical combining plant sterols, bergamot extract, artichoke leaf extract and hydroxytyrosol (referred to as 'Cholesterol Balance'), on serum LDL-cholesterol (primary outcome), other cardiometabolic and oxidative stress markers in adults with hypercholesterolaemia.

Methods: Healthy adults (n = 42, 18-<66 years, body mass index [BMI] >18.5-<35 kg/m²), with mild hypercholesterolaemia (LDL-cholesterol ≥2.5-<5 mmol/L) and low CVD risk participated in a 4-month double-blind randomised placebo-controlled trial. Participants consumed either 3 capsules/day Cholesterol Balance (providing 375 mg Bergavit40™, 150 mg Altilix™, 1.8 g phytosterols, and 50 mg of Hydrovas10™ daily) or placebo. Outcomes were assessed at baseline, 2- and 4-months.

Results: There was no evidence that Cholesterol Balance affected serum LDL-cholesterol compared to placebo (adjusted mean difference [95 % CI] at 4 months between treatments, -0.12 [-0.34, 0.11] mmol/L, p = 0.307). None of the secondary outcomes, including total cholesterol, HDL-cholesterol, triglycerides, non-HDL-cholesterol, total cholesterol:HDL-cholesterol ratio, apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), ApoB:ApoA1 ratio, plasma oxidised LDL, serum malondialdehyde, HbA1c, blood pressure or safety markers showed a significant difference between groups.

Conclusion: While safe to consume, a nutraceutical containing plant sterols, bergamot extract, artichoke leaf extract and hydroxytyrosol did not show evidence of improving serum LDL-cholesterol, or any other lipid and oxidative stress markers in adults with mild hypercholesterolaemia. Further research is needed to determine if ingredients in the complex formulation interact or interfere with LDL-cholesterol lowering mechanisms.

Trial registration: ClinicalTrials.gov NCT04783714.

Keywords: Artichoke leaf; Bergamot; Hyroxytyrosol; LDL-Cholesterol; Nutraceutical; Plant sterols.