gLUCAn: Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Dietary Supplement: Intervention 1
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.
Other Names:
|
| Active Comparator: 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. |
Dietary Supplement: Intervention 2
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.
Other Names:
|
| Active Comparator: 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 |
Dietary Supplement: Intervention 3
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.
Other Names:
|
| Active Comparator: 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. |
Dietary Supplement: Intervention 4
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.
Other Names:
|
| Placebo Comparator: 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. |
Dietary Supplement: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- LDL cholesterol [[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]]
LDL cholesterol [mmol/L]
Secondary Outcome Measures
- 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]
- 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)
- 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
- composition of microbiome [[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]]
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]
- 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 (%)
Eligibility Criteria
Criteria
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
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intake of additional dietary supplements (especially ß-glucan capsules, high-fibre compounds)
-
pregnancy, lactation
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appreciable food allergies/intolerances
-
patient´s request or if patient compliance with the study protocol is doubtful
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Friedrich-Schiller-University | Jena | Thuringia | Germany | 07743 |
Sponsors and Collaborators
- University of Jena
Investigators
- Principal Investigator: Christine Dawczynski, PhD, University of Jena
- Principal Investigator: Stefan Lorkowski, PhD, University of Jena
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H7_18