Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety
NCT ID: NCT03648112
Last Updated: 2023-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
32 participants
INTERVENTIONAL
2018-05-02
2019-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Beta-glucan, Product Claims and Satiety
NCT04740112
The Effect of a Breakfast Meal Containing Oat β-glucan on Food Intake at a Subsequent Meal in Normal-weight and Overweight Subjects
NCT03490851
β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
NCT01317264
Effects of Oligofructose and Barley on Satiety and Energy Intake
NCT00776256
Effect of Oat Compounds on Postprandial Glucose Response
NCT05177172
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
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
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
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Typical western diet
Exclusion Criteria
* 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
25 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Jena
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christine Dawczynski,PhD
Leader of the Junior Research Group Nutritional Concepts
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christine Dawczynski, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Jena
Stefan Lorkowski, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Jena
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Friedrich-Schiller-University
Jena, Thuringia, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Reiners S, Hebestreit S, Wedekind L, Kiehntopf M, Klink A, Rummler S, Glei M, Lorkowski S, Schlormann W, Dawczynski C. Effect of a regular consumption of traditional and roasted oat and barley flakes on blood lipids and glucose metabolism-A randomized crossover trial. Front Nutr. 2023 Feb 2;10:1095245. doi: 10.3389/fnut.2023.1095245. eCollection 2023.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H7_18
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.