Clinical trial NCT03648112: Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism
Glucose Metabolism
Satiety
Keywords: dietary fibres
ß-glucan
low-density-lipoprotein-cholesterol
insulin
fasting glucose
microbiota
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover design
Primary purpose: TREATMENT

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.

Eligibility 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
* 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

Primary outcomes:
measure: LDL cholesterol
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]
Secondary outcomes:
measure: total cholesterol
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]
measure: HDL cholesterol
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]
measure: triacylglycerides
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]
measure: HOMA-index
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: fasting blood glucose
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: kinetic of glycemic answer
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: kinetic of satiety hormones
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: short chain fatty acids in fecal water
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: composition of microbiome
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: blood pressure
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: height
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: weight
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: body-mass index
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
measure: bioelectrical impedance analysis
timeFrame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-University
state: Thuringia
Study officials:
affiliation: University of Jena
name: Christine Dawczynski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Jena
name: Stefan Lorkowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: