Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in faecal bacteria population
研究概览
简要总结
Intake of whole grain cereals has been associated with reducing the risk of hyperlipidaemia and heart disease, however the mechanisms by which oats or oat fractions exert this effect is not totally clear. Furthermore, several large epidemiological studies and a number of recent meta-analyses of nutritional interventions have reported a positive association between increased whole grain intake and reduced risk of developing a range of chronic diseases. Recognising the important role of the gut microbiota in metabolism and metabolic disease risk, we examined the impact of whole grain oats on the human gut microbiota and cardio-metabolic risk factors.
The main aims of this human study is to determine the effectiveness of a low GI whole grain oats breakfast cereal compared to a high GI, refined breakfast cereal to beneficially modulate gut microbiota and its metabolic output, plasma lipids, gut satiety hormones and inflammation markers in an at risk of cardio-metabolic disease population
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and Women (age range 23-64 y)
- •BMI of 18-30kg/m2
- •Fasting glucose concentration >5.5 but <7.5mmol/L
- •Total cholesterol >5.2 but <7.8mmol/L
排除标准
- •medical history of heart disease, diabetes mellitus, cancer, pancreatitis or renal disease
- •use of lipid lowering drugs, systemic corticosteroids or drugs for regulating hemostasis
- •exposure to any investigational agent <42 d before the study
- •presence of gastrointestinal disorder or use of a drug likely to alter gastrointestinal motility or nutrient absorption
- •history of substance misuse or alcoholism
- •current pregnancy, planned pregnancy, or given birth in the past 12 months
- •antibiotic treatment 6 weeks previous to study start date
- •allergy or intolerance to intervention breakfast cereals components
结局指标
主要结局
Changes in faecal bacteria population
时间窗: Changes in faecal bacteria populations upon consumption of the test and control cereals . Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days
次要结局
- Faecal short chain fatty acids(High-performance liquid chromatography (HPLC) was performed to determine faecal SCFA concentration. Faecal samples were collected and analysed at 0, 42, 56, 112, 140 days)
- Changes in plasma lipids(Fasted plasma samples were analysed for determination of triacylglycerol (TAG), total cholesterol (TC), HDL-cholesterol, LDL-cholesterol. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days)
研究者
Julie Lovegrove
Professor
University of Reading