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

Satiety Clinical Trial

— gLUCAn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648112
• Other study ID #: H7_18
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2023
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 31, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism
• Lipid Metabolism
• Satiety

Intervention

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.
• Intervention 2
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.
• Intervention 3
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.
• Intervention 4
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.
• 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.

Locations

Country	Name	City	State
Germany	Friedrich-Schiller-University	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol	LDL cholesterol [mmol/L]	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	HOMA-index	HOMA-index	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Secondary	fasting blood glucose	fasting blood glucose [mg/dl]	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	composition of microbiome	composition of microbiome [%]	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Secondary	blood pressure	systolic and diastolic blood pressure [mmHg]	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Secondary	height	Height [m]	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Secondary	weight	Weight [kg]	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Secondary	body-mass index	body-mass index [kg/m2]	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Secondary	bioelectrical impedance analysis	bioelectrical impedance analysis (%)	[Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

External Links

•   Study results