Health Benefits of Whole Grain Oats in Population at Risk of Cardio-metabolic Disease
2013年8月15日 更新者：Julie Lovegrove、University of Reading
Hypocholesterolaemic and Prebiotic Effects of a Whole-grain Oat-based Breakfast Cereal in a Cardio-metabolic 'at Risk' Population
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
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Berkshire
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Reading、Berkshire、英国、RG6 6AP
- Department of Food and Nutritional Sciences, University of Reading
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
23年 至 64年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- smoking
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Wholegrain cereal oats
Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period.
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Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period
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安慰剂比较：Non wholegrain cereals
Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
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Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Changes in faecal bacteria population
大体时间：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
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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
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Faecal short chain fatty acids
大体时间：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
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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
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Changes in plasma lipids
大体时间：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
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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
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Changes in insulin resistance, PYY and GLP-1
大体时间：Fasted plasma samples were analysed for determination of insulin resistance, PYY and GLP-1. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days
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Fasted plasma samples were analysed for determination of insulin resistance, PYY and GLP-1. Blood plasma samples were collected and analysed at 0, 42, 56, 112, 140 days
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Changes in inflammatory markers
大体时间：Fasted plasma samples were analysed for determination of IL-6, TNF-a while saliva samples were analysed for sIgA and faecal samples for calprotectin. Blood plasma samples and saliva and faecal samples were collected and analysed at 0, 42, 56, 112, 140
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Fasted plasma samples were analysed for determination of IL-6, TNF-a while saliva samples were analysed for sIgA and faecal samples for calprotectin. Blood plasma samples and saliva and faecal samples were collected and analysed at 0, 42, 56, 112, 140
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Changes in dietary intake
大体时间：4-day diet diaries were collected analysed, to determine the macro and micronutrient content of the participant's diets during each intervention arm. Diet diaries were collected at were collected and analysed at 42 and 112 days.
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4-day diet diaries were collected analysed, to determine the macro and micronutrient content of the participant's diets during each intervention arm. Diet diaries were collected at were collected and analysed at 42 and 112 days.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Prof. Julie A Lovegrove, BSc, PhD, RNutr、University of Reading
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Connolly ML, Lovegrove JA, Tuohy KM. In vitro evaluation of the microbiota modulation abilities of different sized whole oat grain flakes. Anaerobe. 2010 Oct;16(5):483-8. doi: 10.1016/j.anaerobe.2010.07.001. Epub 2010 Jul 17.
- Connolly ML, Tuohy KM, Lovegrove JA. Wholegrain oat-based cereals have prebiotic potential and low glycaemic index. Br J Nutr. 2012 Dec 28;108(12):2198-206. doi: 10.1017/S0007114512000281. Epub 2012 Feb 24.
- Connolly ML, Tzounis X, Tuohy KM, Lovegrove JA. Hypocholesterolemic and Prebiotic Effects of a Whole-Grain Oat-Based Granola Breakfast Cereal in a Cardio-Metabolic "At Risk" Population. Front Microbiol. 2016 Nov 7;7:1675. doi: 10.3389/fmicb.2016.01675. eCollection 2016.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年5月1日
初级完成 (实际的)
2009年12月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2013年8月15日
首先提交符合 QC 标准的
2013年8月15日
首次发布 (估计)
2013年8月19日
研究记录更新
最后更新发布 (估计)
2013年8月19日
上次提交的符合 QC 标准的更新
2013年8月15日
最后验证
2013年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.