Intervention Study - Physiological Short-term and Long-term Effects of Regularly Consumption of Beta-glucan From Barley and Oats on the Glucose and Lipid Metabolism and Satiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- LDL cholesterol
研究概览
简要总结
The interventional study will evaluate the effects of a regularly consumption of barley and oat flakes in crude and roasted form on the glucose and lipid metabolism as well as the postprandial saturation. Moreover, the study will evaluate the effect of a regularly consumption of barley and oat flakes on the glucose and lipid metabolism over a period of three weeks.
All participants will run through each intervention (cross-over design). Inbetween these intervention periods there will be wash-out phases. In total there will be four interventions: crude oat flakes, roasted oat flakes, crude barley flakes and roasted barley flakes. The comparison will be made against white toastbread. The study participants will visit the study centrum before and after each intervention over an entire period of 27 weeks.
详细描述
The interventional study will evaluate the effects of a regularly consumption of barley and oat flakes in crude and roasted form on the glucose and lipid metabolism as well as the postprandial saturation. Moreover, the study will evaluate the effect of a regularly consumption of barley and oat flakes on the glucose and lipid metabolism over a period of three weeks.
By applying the cross-over design, all participants will run through each intervention. In total there will be four interventions: crude oat flakes, roasted oat flakes, crude barley flakes and roasted barley flakes. Each intervention period will last three weeks and will be separated by wash-out phases which also will last three weeks. The comparison will be made against white toastbread, which will be the fifth intervention. The entire duration of the study will be 27 weeks (5x 3 weeks intervention + 4x 3 weeks wash-out phases inbetween).
The participants will visit the study centrum before and after each intervention for examinations and for taking blood samples. During the examination the participants will receive a test-meal to evaluate postprandial blood glucose and insulin levels. Moreover, the kinetic of hormones that influence the satiety will be evaluated. In addition to the examination of blood samples, the microbiota of feces will be examined.
During the intervention periods the participants will receive recipes for breakfast for 21 days. In these recipes 80 gram oat or barley flakes or four slices of white toastbread will be included.
The study will provide data about the association between different processed cereals and measurable markers reflecting glucose and lipid metabolism as well as their influence on hormones of satiety and microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LDL-cholesterol ≥ 120 mg/dl (≥ 3 mmol/l)
- •Typical western diet
排除标准
- •intake of lipid-lowering medications
- •gastrointestinal diseases
- •diabetes mellitus type I and II
- •familial hypercholesterolemia
- •intake of additional dietary supplements (especially ß-glucan capsules, high-fibre compounds)
- •pregnancy, lactation
- •appreciable food allergies/intolerances
- •patient´s request or if patient compliance with the study protocol is doubtful
结局指标
主要结局
LDL cholesterol
时间窗: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]
LDL cholesterol \[mmol/L\]
次要结局
- kinetic of satiety hormones([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- short chain fatty acids in fecal water([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- blood pressure([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- height([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- weight([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- bioelectrical impedance analysis([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- body-mass index([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- HDL cholesterol([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L])
- fasting blood glucose([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- total cholesterol([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L])
- composition of microbiome([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- HOMA-index([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
- triacylglycerides([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L])
- kinetic of glycemic answer([Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No])
研究者
Christine Dawczynski,PhD
Leader of the Junior Research Group Nutritional Concepts
University of Jena