Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety
- Conditions
- SatietyLipid MetabolismGlucose Metabolism
- Interventions
- Dietary Supplement: Intervention 4Dietary Supplement: Intervention 2Dietary Supplement: Intervention 3Dietary Supplement: Intervention 1Dietary Supplement: Control
- Registration Number
- NCT03648112
- Lead Sponsor
- University of Jena
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- LDL-cholesterol ≥ 120 mg/dl (≥ 3 mmol/l)
- Typical western diet
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention 4 Intervention 4 Roasted barley flakes (dietary supplement) 80 g of roasted oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes. Intervention 2 Intervention 2 Roasted oat flakes (dietary supplement) 80 g of roasted oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. These oat flakes were roasted at 150°C for 20 minutes. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes. Intervention 3 Intervention 3 Crude barley flakes (dietary supplement) 80 g of crude oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß-glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes Intervention 1 Intervention 1 Intervention 1: Crude oat flakes (dietary supplement) 80 g of crude oat flakes contain 4 g ß-glucan. According to the current Health Claim, 4 g ß glucan are necessary to achieve a reduction of the postprandial glycemic answer and a reduction of the cholesterol concentration in hypercholesterolinaemic patients. The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes. control Control White toastbread (control) (dietary supplement) White toastbread was chosen because of its low fibre content. To achieve the same energy value (kcal) as 80 g cereal flakes the participants have to consume four slices of white toastbread. The study participants receive recipes for breakfast for 21 days. The recipes imply four slices of white toastbread.
- Primary Outcome Measures
Name Time Method LDL cholesterol [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L] LDL cholesterol \[mmol/L\]
- Secondary Outcome Measures
Name Time Method kinetic of satiety hormones [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] Ghrelin, GLP1, peptide YY (timepoints: 0, 30, 60, 120 and 180 min) after a test meal)
short chain fatty acids in fecal water [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] short chain fatty acids (SCFA; %) , pH value, composition of microbiome
blood pressure [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] systolic and diastolic blood pressure \[mmHg\]
height [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] Height \[m\]
weight [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] Weight \[kg\]
bioelectrical impedance analysis [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] bioelectrical impedance analysis (%)
body-mass index [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] body-mass index \[kg/m2\]
HDL cholesterol [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] HDL cholesterol \[mmol/L\]
fasting blood glucose [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] fasting blood glucose \[mg/dl\]
total cholesterol [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] total cholesterol \[mmol/L\]
composition of microbiome [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] composition of microbiome \[%\]
HOMA-index [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] HOMA-index
triacylglycerides [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] triacylglycerides \[mmol/L\]
kinetic of glycemic answer [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] blood glucose (mg/dl; timepoints: 0, 30, 60, 120 and 180 min) after a test meal)
Trial Locations
- Locations (1)
Friedrich-Schiller-University
🇩🇪Jena, Thuringia, Germany