ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Postprandial triglycerides
研究概览
简要总结
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.
详细描述
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.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Gastrointestinal disease
- •Anticoagulation treatment
- •Serious liver, heart or kidney disease
- •Corticosteroid treatment
- •Waist circumference above 130 cm
- •Alcohol or drug addiction
- •Pregnancy og lactation
结局指标
主要结局
Postprandial triglycerides
时间窗: 4 weeks
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.
次要结局
- Metabolic Rate(4 weeks)
- Change in insulin sensitivity(4 weeks)
- Body composition(4 weeks)
- Twenty-Four-Hour Blood Pressure(4 weeks)
- Gene expression in adipose tissue(Four weeks)
- Inflammatory Markers after 4 weeks of intervention(4 weeks)
研究者
AnneMarie Kruse
Professor Kjeld Hermansen
Aarhus University Hospital