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

IF 4.9 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Atherosclerosis Pub Date : 2025-03-22 DOI:10.1016/j.atherosclerosis.2025.119177

Welma Stonehouse , Bianca Benassi-Evans , Jennie Louise

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引用次数: 0

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.

Abstract Image

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一种新型营养品组合对成人高胆固醇血症患者低密度脂蛋白胆固醇和其他心脏代谢健康指标的影响：一项随机双盲安慰剂对照试验

背景与目的有临床证据表明植物甾醇、佛手柑提取物和洋蓟叶提取物单独降低ldl -胆固醇，但它们联合使用的效果尚不清楚。本研究研究了一种新型营养保健品，结合植物甾醇、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”），对成人高胆固醇血症患者血清ldl -胆固醇（主要结局）、其他心脏代谢和氧化应激标志物的影响。方法健康成人（n = 42, 18- 66岁，身体质量指数[BMI] >；18.5-<35 kg/m2），轻度高胆固醇血症（ldl -胆固醇≥2.5-<5 mmol/L），低心血管疾病风险参与4个月的双盲随机安慰剂对照试验。参与者每天服用3粒胆固醇平衡胶囊（每天提供375毫克Bergavit40™，150毫克Altilix™，1.8克植物甾醇和50毫克Hydrovas10™）或安慰剂。在基线、2个月和4个月时评估结果。结果与安慰剂相比，没有证据表明胆固醇平衡影响血清ldl -胆固醇（治疗4个月时校正平均差[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LDL、血清丙二醛、HbA1c、血压或安全指标在内的次要指标在两组间均无显著差异。结论：一种含有植物甾醇、佛手柑提取物、朝鲜蓟叶提取物和羟基酪醇的营养保健品虽然可以安全食用，但并没有显示出改善轻度高胆固醇血症成人血清ldl -胆固醇或任何其他脂质和氧化应激标志物的证据。需要进一步的研究来确定复合配方中的成分是否与低密度脂蛋白胆固醇降低机制相互作用或干扰。

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来源期刊

Atherosclerosis 医学-外周血管病

CiteScore

9.80

自引率

3.80%

发文量

1269

审稿时长

36 days

期刊介绍： Atherosclerosis has an open access mirror journal Atherosclerosis: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review. Atherosclerosis brings together, from all sources, papers concerned with investigation on atherosclerosis, its risk factors and clinical manifestations. Atherosclerosis covers basic and translational, clinical and population research approaches to arterial and vascular biology and disease, as well as their risk factors including: disturbances of lipid and lipoprotein metabolism, diabetes and hypertension, thrombosis, and inflammation. The Editors are interested in original or review papers dealing with the pathogenesis, environmental, genetic and epigenetic basis, diagnosis or treatment of atherosclerosis and related diseases as well as their risk factors.