ACTRN12624000424505撤回Unknown
Investigating the effects of mushrooms compared to non-starchy vegetables on low-density lipoprotein cholesterol (LDL-C) in adults with mild hypercholesterolaemia – a randomised controlled cross-over trial
Commonwealth Scientific and Industrial Research Organisation (CSIRO)0 个研究点目标入组 42 人开始时间: 2024年4月8日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 撤回
- 入组人数
- 42
研究概览
简要总结
暂无简介。
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 65 Years（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA:
- •1.Willing and able to provide written Informed Consent
- •2.Access to a personal email inbox
- •3.Male or Female individuals
- •4.Aged > or equal to 18 & <66 years of age at clinic screening
- •5.BMI > or equal to 18.5 kg/m2 and <35 kg/m2 at time of clinic screening
- •6.Low cardiovascular disease (CVD) risk score in individuals aged > or equal to 45 years of <5% estimated 5-year CVD risk determined using the Australian CVD risk calculator (cvdcheck.org.au)
- •7.Fasting LDL-cholesterol > or equal to 3.0 mmol/L and < or equal to 5 mmol/L confirmed at clinic screening (plasma)
- •8.Have access to a Coles supermarket
- •9.Ability to refrigerate mushrooms/vegetables and have the facilities to prepare and cook them
排除标准
- •EXCLUSION CRITERIA:
- •1.Use of and not prepared to abstain from marine and algae derived omega-3 supplements at high dose (>900 mg/day of docosahexaenoic acid (DHA) / eicosapentaenoic acid (EPA)) or marine and algae derived omega 3 fortified foods that may, in the opinion of the PI or designee, affect lipid concentrations, within the 84 days of Day 0
- •2.Use of lipid lowering medications (e.g. statins, metformin, fibrates, cholesterol absorption inhibitors, nicotinic acid) or lipid raising medications (eg. Beta blockers, steroids, amiodarone, diuretics) within 28 days of Day 0.
- •3.Use of and not prepared to abstain from supplements, or foods containing ß-glucan (oats, barley, rye, nutritional yeast, mushrooms other than study mushrooms) or other substances (e.g. psyllium, plant sterol fortified foods and supplements, curcumin, turmeric) that may, in the opinion of the PI or designee, affect lipid concentrations within 14 days of Day 0
- •4.Previous diagnosis of chronic disease such as CVD, diabetes
- •(Type I, Type II, and/or Gestational Diabetes), cancer, familial hypercholesterolaemia, kidney disease, liver disease
- •5.Smoking (i.e., history of smoking within the last six months)
- •6.Serum triglycerides >4.5mmol/L (LDL-cholesterol concentrations are unreliable in the presence of high triglyceride levels) confirmed at clinic screening (using capillary plasma)
- •7.Hypertension (blood pressure > or equal to 140/90mmHg)
- •8.Suspected aversion and/or intolerance to mushrooms
- •9.Unwilling or unable to maintain usual levels of physical activity or dietary intake for the duration of the study
- •10.Currently pregnant and/or nursing (lactating), self-reported by the applicant
- •11.Currently hospitalised or any planned hospitalisations during the study that may affect the applicant’s ability to comply with the study in the opinion of the PI or designee
- •12.Received an investigational drug within 90 days of Day 0, that in the opinion of the PI or designee may affect the outcome of the study
- •13.Unable to comply, experience distress with study procedures, or has a medical condition and/or receiving medical treatments (including medications) that in the opinion of the PI or designee, may affect the outcome of the study
- •14.Travel which may interfere with complying to the study diet guidelines
研究者
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