Friedrich-Schiller-University
Jena, Thuringia, 07743, Germany
NCT Number: NCT03648112
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.
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Notify Me25 year–65 year
All sexes
Interventional
Not applicable
Jena, Thuringia, 07743, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.
Other names: Crude oat flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.
Other names: Roasted oat flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.
Other names: Crude barley flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.
Other names: 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.
Other names: White toast bread
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]
LDL 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]
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 [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 [mmol/L]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
HOMA-index
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
fasting blood glucose [mg/dl]
Time frame: [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)
Time frame: [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)
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
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 [%]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
systolic and diastolic blood pressure [mmHg]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Height [m]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Weight [kg]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
body-mass index [kg/m2]
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
bioelectrical impedance analysis (%)
University of Jena
Other
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
Acronym: gLUCAn
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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