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Trial record 11 of 15 for:    meal | barley

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

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ClinicalTrials.gov Identifier: NCT03648112
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Christine Dawczynski,PhD, University of Jena

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
Lipid Metabolism Glucose Metabolism Satiety Dietary Supplement: Intervention 1 Dietary Supplement: Intervention 2 Dietary Supplement: Intervention 3 Dietary Supplement: Intervention 4 Dietary Supplement: Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: crossover design
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: Crude oat flakes

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 Name: Roasted oat flakes

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 Name: Crude barley flakes

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 Name: Roasted barley flakes

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 Name: White toast bread




Primary Outcome Measures :
  1. LDL cholesterol [ Time Frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L] ]
    LDL cholesterol [mmol/L]


Secondary Outcome Measures :
  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 (%)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648112


Contacts
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Contact: Christine Dawczynski, PhD +49 3641 949656 christine.dawczynski@uni-jena.de
Contact: Sarah Reiners, PhD +49 3641 949726 sarah.reiners@uni-jena.de

Locations
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Germany
Friedrich-Schiller-University Recruiting
Jena, Thuringia, Germany, 07743
Contact: Christine Dawczynski, PhD    +49 3641 949656    christine.dawczynski@uni-jena.de   
Contact: Stefan Lorkowski, PhD    +49 3641 949711    stefan.lorkowski@uni-jena.de   
Sponsors and Collaborators
University of Jena
Investigators
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Principal Investigator: Christine Dawczynski, PhD University of Jena
Principal Investigator: Stefan Lorkowski, PhD University of Jena

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Responsible Party: Christine Dawczynski,PhD, Leader of the Junior Research Group Nutritional Concepts, University of Jena
ClinicalTrials.gov Identifier: NCT03648112     History of Changes
Other Study ID Numbers: H7_18
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christine Dawczynski,PhD, University of Jena:
dietary fibres
ß-glucan
low-density-lipoprotein-cholesterol
insulin
fasting glucose
microbiota