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Completed

NCT Number: NCT03648112

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

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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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention 1

Dietary Supplement

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

Intervention 2

Dietary Supplement

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

Intervention 3

Dietary Supplement

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

Intervention 4

Dietary Supplement

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

Control

Dietary Supplement

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

Primary outcomes

  1. LDL cholesterol

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]

    LDL cholesterol [mmol/L]

Secondary outcomes

  1. total cholesterol

    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]

  2. HDL cholesterol

    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]

  3. triacylglycerides

    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]

  4. HOMA-index

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    HOMA-index

  5. fasting blood glucose

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    fasting blood glucose [mg/dl]

  6. kinetic of glycemic answer

    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)

  7. kinetic of satiety hormones

    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)

  8. short chain fatty acids in fecal water

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    short chain fatty acids (SCFA; %) , pH value, composition of microbiome

  9. composition of microbiome

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    composition of microbiome [%]

  10. blood pressure

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    systolic and diastolic blood pressure [mmHg]

  11. height

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    Height [m]

  12. weight

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    Weight [kg]

  13. body-mass index

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    body-mass index [kg/m2]

  14. bioelectrical impedance analysis

    Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]

    bioelectrical impedance analysis (%)

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study 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

Acronym: gLUCAn

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 27, 2018
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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