Lipid MetabolismgLUCAnNCT03648112
Effects of Beta-glucan From Barley and Oats on Glucose and Lipid Metabolism, and Satiety
A study testing Intervention 1, Intervention 2 and Intervention 3 in people with Lipid Metabolism and Glucose Metabolism, run by University of Jena at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism, Glucose Metabolism, Satiety
- What is being tested?
- Intervention 1, Intervention 2 and Intervention 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL-cholesterol ≥ 120 mg/dl (≥ 3 mmol/l)
- Typical western diet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Lipid Metabolism, Glucose Metabolism, Satiety
- Being tested
- Intervention 1, Intervention 2, Intervention 3, Intervention 4, Control
- Keywords
- dietary fibres, ß-glucan, low-density-lipoprotein-cholesterol, insulin, fasting glucose, microbiota
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Dietary supplement
Also called Crude oat flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.
Intervention 2Dietary supplement
Also called Roasted oat flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.
Intervention 3Dietary supplement
Also called Crude barley flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.
Intervention 4Dietary supplement
Also called Roasted barley flakes
The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.
ControlDietary supplement
Also called White toast bread
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Active comparator | 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. Receives: Dietary Supplement: Intervention 1 |
| Intervention 2 | Active comparator | 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. Receives: Dietary Supplement: Intervention 2 |
| Intervention 3 | Active comparator | 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 Receives: Dietary Supplement: Intervention 3 |
| Intervention 4 | Active comparator | 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. Receives: Dietary Supplement: Intervention 4 |
| control | Placebo comparator | 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. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
LDL cholesterol [mmol/L]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]
Secondary outcomes (14)
total cholesterol
total cholesterol [mmol/L]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]
HDL cholesterol
HDL cholesterol [mmol/L]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]
triacylglycerides
triacylglycerides [mmol/L]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L]
HOMA-index
HOMA-index
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
fasting blood glucose
fasting blood glucose [mg/dl]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
kinetic of glycemic answer
blood glucose (mg/dl; timepoints: 0, 30, 60, 120 and 180 min) after a test meal)
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
kinetic of satiety hormones
Ghrelin, GLP1, peptide YY (timepoints: 0, 30, 60, 120 and 180 min) after a test meal)
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
short chain fatty acids in fecal water
short chain fatty acids (SCFA; %) , pH value, composition of microbiome
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
composition of microbiome
composition of microbiome [%]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
blood pressure
systolic and diastolic blood pressure [mmHg]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
height
Height [m]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
weight
Weight [kg]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
body-mass index
body-mass index [kg/m2]
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
bioelectrical impedance analysis
bioelectrical impedance analysis (%)
Measured: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start2 May 2018
- Primary completion31 May 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipid MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- crossover design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
- Investigators
- Christine Dawczynski, PhD, Principal investigator, University of JenaStefan Lorkowski, PhD, Principal investigator, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648112
- Sponsor's protocol ID
- H7_18
- Acronym
- gLUCAn
- Status last verified
- Feb 2023
- First submitted
- 21 Aug 2018
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36819683
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03648112
- Acronym / sponsor ID
- gLUCAn / H7_18
- Conditions
- Lipid Metabolism, Glucose Metabolism, Satiety
- Keywords
- dietary fibres, ß-glucan, low-density-lipoprotein-cholesterol, insulin, fasting glucose, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- crossover design
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Active comparator | Dietary Supplement: Intervention 1Intervention 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 2 | Active comparator | Dietary Supplement: Intervention 2Roasted 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 3 | Active comparator | Dietary Supplement: Intervention 3Crude 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 4 | Active comparator | Dietary Supplement: Intervention 4Roasted 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. |
| control | Placebo comparator | Dietary Supplement: ControlWhite 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LDL-cholesterol ≥ 120 mg/dl (≥ 3 mmol/l)
- Typical western diet
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1Also: Crude oat flakesThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day. | Dietary supplement | Intervention 1 |
| Intervention 2Also: Roasted oat flakesThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day. | Dietary supplement | Intervention 2 |
| Intervention 3Also: Crude barley flakesThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day. | Dietary supplement | Intervention 3 |
| Intervention 4Also: Roasted barley flakesThe study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day. | Dietary supplement | Intervention 4 |
| ControlAlso: White toast breadWhite 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 |
Primary outcome
LDL cholesterol
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]
LDL cholesterol [mmol/L]
14 secondary outcomes
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]
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]
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]
HOMA-index
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
fasting blood glucose
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
kinetic of glycemic answer
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
kinetic of satiety hormones
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
short chain fatty acids in fecal water
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
composition of microbiome
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
blood pressure
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
height
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
weight
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
body-mass index
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
bioelectrical impedance analysis
Time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 36819683Reiners 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.
- Study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Dawczynski, PhD principal investigator
University of Jena
Stefan Lorkowski, PhD principal investigator
University of Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1, Intervention 2 and Intervention 3 in people with Lipid Metabolism and Glucose Metabolism, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol (time frame: [Time Frame: change from baseline to 3 weeks intervention] [Safety Issue: No] [mmol/L]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.