An interventional study of Intervention 1 and Intervention 2 in Lipid Metabolism, Glucose Metabolism and Satiety, sponsored by University of Jena. Completed at 1 site in Germany. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by University of Jena · Not applicable, Interventional, and Treatment
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.
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.
University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.
Also known as: Crude oat flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.
Also known as: Roasted oat flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.
Also known as: Crude barley flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.
Also known as: Roasted barley flakes
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.
Also known as: White toast bread
LDL cholesterol
LDL cholesterol \[mmol/L\]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]
total cholesterol
total cholesterol \[mmol/L\]
Time frame: [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: [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: [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: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
fasting blood glucose
fasting blood glucose \[mg/dl\]
Time frame: [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: [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: [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: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
composition of microbiome
composition of microbiome \[%\]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
blood pressure
systolic and diastolic blood pressure \[mmHg\]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
height
Height \[m\]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
weight
Weight \[kg\]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
body-mass index
body-mass index \[kg/m2\]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
bioelectrical impedance analysis
bioelectrical impedance analysis (%)
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
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