Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lipid Metabolism, Glucose Metabolism, Satiety

Intervention / Treatment
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* Dietary Supplement: Intervention 1
* Dietary Supplement: Intervention 2
* Dietary Supplement: Intervention 3
* Dietary Supplement: Intervention 4
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL-cholesterol ≥ 120 mg/dl (≥ 3 mmol/l) Typical western diet Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention 1<br>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. | Dietary Supplement: Intervention 1<br>* The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.<br>* Other names: Crude oat flakes;|
| Active Comparator: Intervention 2<br>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. | Dietary Supplement: Intervention 2<br>* The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.<br>* Other names: Roasted oat flakes;|
| Active Comparator: Intervention 3<br>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 | Dietary Supplement: Intervention 3<br>* The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.<br>* Other names: Crude barley flakes;|
| Active Comparator: Intervention 4<br>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. | Dietary Supplement: Intervention 4<br>* The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.<br>* Other names: Roasted barley flakes;|
| Placebo Comparator: control<br>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. | Dietary Supplement: Control<br>* 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.<br>* Other names: White toast bread;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol | LDL cholesterol [mmol/L] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cholesterol | total cholesterol [mmol/L] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] | 
| HDL cholesterol | HDL cholesterol [mmol/L] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] | 
| triacylglycerides | triacylglycerides [mmol/L] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] | 
| HOMA-index | HOMA-index | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| fasting blood glucose | fasting blood glucose [mg/dl] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| kinetic of glycemic answer | blood glucose (mg/dl; timepoints: 0, 30, 60, 120 and 180 min) after a test meal) | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| kinetic of satiety hormones | Ghrelin, GLP1, peptide YY (timepoints: 0, 30, 60, 120 and 180 min) after a test meal) | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| short chain fatty acids in fecal water | short chain fatty acids (SCFA; %) , pH value, composition of microbiome | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| composition of microbiome | composition of microbiome [%] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| blood pressure | systolic and diastolic blood pressure [mmHg] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| height | Height [m] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| weight | Weight [kg] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| body-mass index | body-mass index [kg/m2] | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 
| bioelectrical impedance analysis | bioelectrical impedance analysis (%) | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary fibres, ß-glucan, low-density-lipoprotein-cholesterol, insulin, fasting glucose, microbiota