Stonehouse Welma, Benassi-Evans Bianca, Louise Jennie
Commonwealth Scientific Industrial Research Organisation (CSIRO), Health and Biosecurity, Adelaide, South Australia, Australia.
Biostatistics Unit, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Atherosclerosis. 2025 Apr;403:119177. doi: 10.1016/j.atherosclerosis.2025.119177. Epub 2025 Mar 22.
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.
Healthy adults (n = 42, 18-<66 years, body mass index [BMI] >18.5-<35 kg/m), 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.
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.
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.
有临床证据表明，植物甾醇、佛手柑提取物和朝鲜蓟叶提取物各自都具有降低低密度脂蛋白胆固醇（LDL - 胆固醇）的作用，但它们联合使用时的效果尚不清楚。本研究调查了一种新型营养保健品，其包含植物甾醇、佛手柑提取物、朝鲜蓟叶提取物和羟基酪醇（称为“胆固醇平衡素”），对高胆固醇血症成年人血清LDL - 胆固醇（主要结局指标）、其他心脏代谢和氧化应激标志物的影响。
健康成年人（n = 42，年龄18 - <66岁，体重指数[BMI] >18.5 - <35 kg/m²），患有轻度高胆固醇血症（LDL - 胆固醇≥2.5 - <5 mmol/L）且心血管疾病风险较低，参与了一项为期4个月的双盲随机安慰剂对照试验。参与者每天服用3粒胆固醇平衡素胶囊（每天提供375 mg Bergavit40™、150 mg Altilix™、1.8 g植物甾醇和50 mg Hydrovas10™）或安慰剂。在基线、2个月和4个月时评估结局指标。
与安慰剂相比，没有证据表明胆固醇平衡素会影响血清LDL - 胆固醇（治疗4个月时组间调整后平均差异[95% CI]为 - 0.12 [-0.34, 0.11] mmol/L，p = 0.307）。包括总胆固醇、高密度脂蛋白胆固醇、甘油三酯、非高密度脂蛋白胆固醇、总胆固醇:高密度脂蛋白胆固醇比值、载脂蛋白A1（ApoA1）、载脂蛋白B（ApoB）、ApoB:ApoA1比值、血浆氧化型LDL、血清丙二醛、糖化血红蛋白、血压或安全性指标在内的所有次要结局指标在两组之间均未显示出显著差异。
虽然食用安全，但含有植物甾醇、佛手柑提取物、朝鲜蓟叶提取物和羟基酪醇的营养保健品在轻度高胆固醇血症成年人中未显示出改善血清LDL - 胆固醇或任何其他脂质和氧化应激标志物的证据。需要进一步研究以确定复合制剂中的成分是否会相互作用或干扰LDL - 胆固醇降低机制。
