ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome (ButCoIns)
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high risk of developing Type 2 Diabetes and cardiovascular disease.
Dietary fibers have been shown to have positive effects on the components of MetS. The investigators have special interest in the combination of two types of fiber (Resistant (RS) starch and Arabinoxylans (AX)) .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and markers of inflammation.
The subjects undergo two dietary interventions of 4 weeks duration each: A "Healthy Carbohydrate Diet" with a high content of RS and AX is compared to a "Western Style Diet" with a low content of RS and AX.
研究概览
详细说明
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, dyslipidemia, hypertension and impaired glucose tolerance. Subjects with MetS have high risk of developing Type 2 Diabetes and CVD.
Resistant Starch (RS) and Arabinoxylans (AX) are dietary fibers that have been shown to have positive effects on the components of MetS. The combination of RS and AX has not been tested before .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases postprandial lipaemia, improves glucose tolerance, insulin resistance, blood pressure and markers of inflammation.
Design:
A nonblinded randomized cross over study Two dietary interventions of 4 weeks duration each. A healthy carbohydrate Diet with a high content of RS and AX is compared to a Western Style diet with a low content of RS and AX. Between the two interventions, there is a wash out period of 4 weeks.
The primary outcome is postprandial lipaemia estimated by a high fat meal test of 6 hours duration. The test is performed before and after each intervention.
Secondary outcomes are:
- Glucose tolerance and insulin resistance estimated by OGTT
- 24 hours blood pressure
- MRI estimation of liver fat content
- Postprandial changes in genes of adipose tissue
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Aarhus、丹麦、8000
- Aarhus University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria: At least 3 out of the 5 following criterions
- Central obesity (Female >80 cm, Male >94)
- HDL cholesterol (female < 1,03 mmol/l, male < 1,29 mmol/l)
- Blood Pressure (> 130/85)
- Fasting Blood Glucose > 5,6 mmol/L
Exclusion Criteria:
- Diabetes
- Gastrointestinal disease
- Anticoagulation treatment
- Serious liver, heart or kidney disease
- Anaemia
- Corticosteroid treatment
- Waist circumference above 130 cm
- Alcohol or drug addiction
- Pregnancy og lactation
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
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安慰剂比较：Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postprandial triglycerides
大体时间：4 weeks
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Plasma Triglycerides are estimated during a high fat meal test of 6 hours duration.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in insulin sensitivity
大体时间：4 weeks
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-Estimated by an OGTT where glucose and insulin are measured several times and insulin sensitivity is estimated according to the Matsuda Index.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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Metabolic Rate
大体时间：4 weeks
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The metabolic rate is measured by indirect calometri (Deltatrac II) in the fasting state and two hours after ingestion of a fatty mixed meal.
The test is performed before and after each intervention period.
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4 weeks
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Body composition
大体时间：4 weeks
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H-MRS of liver before and after intervention in order to estimate the fat content.
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4 weeks
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Twenty-Four-Hour Blood Pressure
大体时间：4 weeks
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Performed in the free-living situation.
Data analysis are grouped in mean day, mean night and mean 24 h.
Measured at baseline and at the end of each intervention.
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4 weeks
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Gene expression in adipose tissue
大体时间：Four weeks
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Fat biopsies are take from abdominal adipose tissue and analyzed by real time PCR to see if gene expression changes after a high intake of dietary fiber.
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Four weeks
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Inflammatory Markers after 4 weeks of intervention
大体时间：4 weeks
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hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
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4 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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