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临床试验/ACTRN12615000956505
ACTRN12615000956505已完成未知

Complementary and/or synergistic effects of phytosterols and curcumin on cardiovascular disease risk factors in hypercholesterolaemic adults.

niversity of Newcastle0 个研究点目标入组 76 人开始时间: 2015年9月11日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
76

研究概览

简要总结

This research project aimed to investigate if combined dietary supplementation with plant sterols (PS) and curcumin (CC) reduces blood cholesterol and to a larger extent than either of the treatments alone. Cardiovascular disease (CVD) remains the leading cause of death globally. It is characterised by a vast collection of risk factors that can be modified and not-modified. Abnormal blood cholesterol/fats levels are a major modifiable risk factor. In addition, chronic inflammation goes hand-in-hand with elevated cholesterol to initiate atherosclerosis. More effective treatment/management strategies are required to prevent CVD. This was trialled in adults who had elevated blood cholesterol but were not medicated or taking supplements for their cholesterol, did not have any other chronic diseases, were otherwise healthy and free-living in the community. Participants were to consume the study products daily as part of their habitual diet and lifestyle over 4 weeks. PS-alone and PS+CC significantly reduced fasting total cholesterol, LDL-cholesterol and total cholesterol-to-HDL-cholesterol ratio in hypercholesterolaemic adults in 4 weeks in a randomised, placebo-controlled trial. Concurrent supplementation with PS and CC exhibited enhanced hypocholesterolaemic effects compared to either treatment administered alone. Implications include the development of a novel functional food containing both bioactives, long-term studies and larger samples to further substantiate our findings.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 70 Years(—)
性别
All

入选标准

  • * Age: 18-70 years
  • * Gender: both males and females
  • * Total cholesterol levels greater than or equal to 5.5mmol/L (after a 10 hour fast)

排除标准

  • * Pregnant or lactating
  • * History of cardiovascular events (e.g. stroke, heart attack, angina, aneurysm, hemorrhage, myocardial infarction etc)
  • * People with pace maker implants
  • * Diabetes mellitus
  • * A chronic inflammatory disease and/or condition (e.g. cancer)
  • * Hypertension
  • * Liver or renal disease
  • * Taking anti-inflammatory medications/supplements (e.g. Aspirin, Atacand, Celebrex)
  • * Taking hypolipidaemic medications/supplements (e.g. Lipitor, Crestor, Zocor)
  • * Taking regular dietary supplements known to influence blood lipid levels (e.g. fish oil, fibre, curcumin)
  • * Already consuming phytosterol-enriched products on a daily and/or regular basis (approximately 4 days/week)
  • * Strong allergies/intolerance/sensitivities or food aversions to the foods involved in this study
  • * History of gastric ulcers, lung and respiratory diseases
  • * History of severe neurological diseases or seizures
  • * BMI greater than 40

研究者

发起方
niversity of Newcastle

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