Glucose Metabolism, Lipid Metabolism, Satiety
Conditions
Keywords
dietary fibres, ß-glucan, low-density-lipoprotein-cholesterol, insulin, fasting glucose, microbiota
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.
Interventions
DIETARY_SUPPLEMENTIntervention 1
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.
DIETARY_SUPPLEMENTIntervention 2
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.
DIETARY_SUPPLEMENTIntervention 3
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.
DIETARY_SUPPLEMENTIntervention 4
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.
DIETARY_SUPPLEMENTControl
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.
Sponsors
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
crossover design
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL cholesterol | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L] | LDL cholesterol \[mmol/L\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[kg\] |
| body-mass index | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | body-mass index \[kg/m2\] |
| bioelectrical impedance analysis | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | bioelectrical impedance analysis (%) |
| 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) |
| 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) |
| blood pressure | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | systolic and diastolic blood pressure \[mmHg\] |
| composition of microbiome | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | composition of microbiome \[%\] |
| 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 \[mmol/L\] |
| 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 \[mmol/L\] |
| triacylglycerides | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] | triacylglycerides \[mmol/L\] |
| HOMA-index | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | HOMA-index |
| fasting blood glucose | [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] | fasting blood glucose \[mg/dl\] |
| 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 |
Countries
Germany
Outcome results
None listed