The Effects of Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- LDL cholesterol
研究概览
简要总结
The primary aim of this study is to directly compare the two major types of anthocyanins found in the diet (cyanidin-type and delphinidin-type) on lipid status in adults.
详细描述
Human intervention trials with anthocyanin-rich berry fruits/extracts such as whole strawberries, elderberry juice and whortleberry extracts, and purified anthocyanins from a mixture of blackcurrant and bilberry have been shown to beneficially alter biological markers for CVD risk, with beneficial effects on lipid profiles common across these studies.
In a randomized 3 phase crossover study we aim to recruit 50 participants (men and women) aged 45 years or more with a higher than optimal blood cholesterol level to consume capsules containing (i) 320 mg anthocyanins derived from bilberry fruit (delphinidin type), (ii) 320 mg anthocyanins derived from black rice (cyanidin type) and (iii) a placebo control. Each treatment will be ingested for 28 days with a wash-out period of 4 weeks in-between. Blood samples will be collected at the start and end of each 28-day treatment period to assess lipid status. In a subset of participants we will also investigate the relationship between bilberry and black rice anthocyanin ingestion on RNA expression profiles that are known to be involved in atherosclerosis, non-alcoholic fatty liver disease and reverse cholesterol transport as well as faecal excretion of bile acids and lipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 45 years of age
- •Total cholesterol ≥ 5.0 mmol/L
排除标准
- •Smokers (or stopped smoking for less than 3 months)
- •Medical conditions that are judged to affect the primary outcome measure for this study or which may compromise the well-being of the participant e.g. diabetes.
- •Prescribed and non-prescribed medications that may affect the primary outcome measure for this study e.g. lipid lowering therapy
- •Dietary supplements judged to affect the study data unless the participant is willing to discontinue them for 4 weeks preceding the start of the study and for the duration of the study
- •Use foods for lowering cholesterol e.g. benecol, flora proactive
- •Regular/recent use of colonic irrigation or other bowel cleansing techniques.
- •Intend to change the normal use of pre or probiotics during the study (only applies to those collecting faecal samples)
- •Bowel movements ≤ 3 times per week (only applies to those collecting faecal samples)
- •Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
- •Parallel participation in another research project which involves dietary intervention
- •Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml.
- •Has donated or intends to donate blood within 16 weeks prior to or during the study period.
- •Any person related to or living with any member of the study team
- •Lack of capacity to provide written informed consent
- •Are pregnant or have been pregnant within the last 12 months
结局指标
主要结局
LDL cholesterol
时间窗: 28 days
Serum lipid status
次要结局
- Total/HDL cholesterol and triglycerides(28 days)
- Cholesterol efflux capacity(28 days)
- PON-1 activity(28 days)
- Bile acids and derivatives(28 days)
- MicroRNA expression(28 days)
- Glucose, fructosamine and insulin(28 days)