Metabolic SyndromeNCT01583270
Effect of Arabinoxylan and Rye Kernels on Second Meal Responses
A study testing Arabinoxylan, Rye kernel and Arabinoxylan and rye kernels in people with Metabolic Syndrome, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Sedentary lifestyles and increasing obesity are main causes of the global increase in the prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality, particularly composition of carbohydrate play also a significant role. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Arabinoxylan, Rye kernel and Arabinoxylan and rye kernels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Oct 2012
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Central obesity (Female > 94 cm; Male > 80 cm) with two of the following:
- fasting triglyceride (> 1,7 mmol/L),
- HDL-cholesterol: (Female:< 1,03 mmol/L; Male:< 1,29 mmol/L),
- blood pressure (≥ 130/85 mmHg) and
- fasting plasma glucose (≥ 5,6 mmol/L)). Subjects who are in medical treatment with lipid and blood pressure-lowering drugs can continue with their habitual treatment provided that the treatment is stable throughout the trial.
Who cannot join
- fasting plasma glucose > 7,0 mmol/l,
- fasting plasma triglyceride > 5,0 mmol/l,
- blood pressure > 160/100 mmHg ,
- legal incapacity , endocrine, cardiovascular or kidney disease,
- BMI > 38kg/m2,
- corticosteroid treatment,
- alcohol or drug addiction and
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arabinoxylan and Rye Kernels on Second Meal Responses in Subjects With the Metabolic Syndrome
Sedentary lifestyles and increasing obesity are main causes of the global increase in the prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality, particularly composition of carbohydrate play also a significant role. Barley, oat and rye may in addition to reducing the acute post prandial glucose response also reduce glucose response at a subsequent meal. Purified dietary fibre has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effect of arabinoxylan, which constitute a substantial part of dietary fibre in cereal products, is limited in relation to second meal effects. The investigators also lack knowledge of the second meal effect of arabinoxyan in combination with rye kernels.
Hypothesis: Porridge rich in arabinoxylan and/or whole rye kernels can increase the formation of short chain fatty acids and improve the glycemic response.
Read more
The aim of the present study is to compare the effect of porridge test meals based on purified arabinoxylan, rye kernels, a combination of arabinoxylan and rye kernels, and semolina porridge as control on acute postprandial response as well as response at a subsequent standardized meal. The study will be conducted in subjects with the metabolic syndrome. The primary endpoint is glucose response. Secondary endpoints are the following items: insulin, incretins, inflammatory markers, ghrelin, free fatty acids, metabolomics, breath hydrogen and subjective satiety feeling.
This project will improve opportunities for identifying and designing foods with low GI that is particularly suited to people who are at high risk of developing T2DM. The investigators also expect to gain a greater understanding of the metabolic fingerprint, as seen after ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods affect health by altering metabolic processes. This will give us a deeper insight into the metabolic processes that are necessary for maintaining normal glucose homeostasis
Read the detailed description
Using a cross-over design, 15 subjects with Mets will consume test meals containing four different porridges in randomized order. Blood samples will be collected over 2 hours after ingestion of test meals and 2 hours after ingestion of a standard second lunch meal served 4 hours after the test meals. The amount of porridge and the standard lunch are equivalent to 50 g available carbohydrate. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling and measurements of breath hydrogen will be used as a marker for colon fermentation.
- Conditions
- Metabolic Syndrome
- Being tested
- Arabinoxylan, Rye kernel, Arabinoxylan and rye kernels, Semolina
- Keywords
- Arabinxylan, Rye kernels, whole grain, Dietary fibre, Metabolic syndrome, Glycemic response, Colon fermentation, Second meal effekt, Satiety
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArabinoxylanDietary supplement
Also called Dietary fibre.
Porridge rich in arabinoxylan
Rye kernelDietary supplement
Also called Whole grain. Rye. Kernels.
Porridge made of rye kernels
Arabinoxylan and rye kernelsDietary supplement
Also called dietary fibre. whole grain. rye kernels.
Porridgde made of rye kernels and arabinoxylan
SemolinaDietary supplement
Also called Wheat.
Semoline porridge. control meal.
| Study group | Role | What they receive |
|---|---|---|
| Arabinoxylan | Experimental | Porridge rich in arabinoxylan. 50 g available carbohydrate Receives: Dietary Supplement: Arabinoxylan |
| rye kernels | Experimental | Porridge made from rye kernels. 50 g available carbohydrate Receives: Dietary Supplement: Rye kernel |
| arabinoxylan and rye kernels | Experimental | Porridge made of rye kernels and arabinoxylan. 50g available carbohydrate Receives: Dietary Supplement: Arabinoxylan and rye kernels |
| semolina | Experimental | Semoline porridge. 50 g available carbohydrate Receives: Dietary Supplement: Semolina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response after second meal
Measured: 2 hours
Secondary outcomes (6)
Plasma response after second meal
Plasma insulin, incretins, ghrelin, short chain fatty acids, freee fatty acids, inflammation markers, and metabolomics.
Measured: 2 hours
Plasma response after test meal
Plasma glucose, insulin, incretins, short chain fatty acids, free fatty acids, metabolomisc.
Measured: 2 hours
Breath hydrogen after second meal
Breath hydrogen as marker for colon fermentation
Measured: 2 hours
Breath hydrogen after testmeal
Breath hydrogen as marker for colen fermentation
Measured: 2 hours
Satiety feeling after second meal
Measured: 2 hours
Satiety feeling after test meal
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, AnneMarie Kruse, Aarhus University Hospital
- Investigators
- Kjeld Hermansen, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583270
- Sponsor's protocol ID
- CERN-biofuncarb second meal
- Other IDs
- 2101-08-0068
- Status last verified
- Jun 2013
- First submitted
- 18 Apr 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arabinoxylan and Rye Kernels on Second Meal Responses in Subjects With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01583270
- Acronym / sponsor ID
- CERN-biofuncarb second meal
- Conditions
- Metabolic Syndrome
- Keywords
- Arabinxylan, Rye kernels, whole grain, Dietary fibre, Metabolic syndrome, Glycemic response, Colon fermentation, Second meal effekt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Apr 2012 (estimated)
- 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.
Sedentary lifestyles and increasing obesity are main causes of the global increase in the prevalence of the metabolic syndrome (Mets) and type 2 diabetic (T2DM). Diet quality, particularly composition of carbohydrate play also a significant role. Barley, oat and rye may in addition to reducing the acute post prandial glucose response also reduce glucose response at a subsequent meal. Purified dietary fibre has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effect of arabinoxylan, which constitute a substantial part of dietary fibre in cereal products, is limited in relation to second meal effects. The investigators also lack knowledge of the second meal effect of arabinoxyan in combination with rye kernels.
Hypothesis: Porridge rich in arabinoxylan and/or whole rye kernels can increase the formation of short chain fatty acids and improve the glycemic response.
The aim of the present study is to compare the effect of porridge test meals based on purified arabinoxylan, rye kernels, a combination of arabinoxylan and rye kernels, and semolina porridge as control on acute postprandial response as well as response at a subsequent standardized meal. The study will be conducted in subjects with the metabolic syndrome. The primary endpoint is glucose response. Secondary endpoints are the following items: insulin, incretins, inflammatory markers, ghrelin, free fatty acids, metabolomics, breath hydrogen and subjective satiety feeling.
This project will improve opportunities for identifying and designing foods with low GI that is particularly suited to people who are at high risk of developing T2DM. The investigators also expect to gain a greater understanding of the metabolic fingerprint, as seen after ingestion of low-GI foods and thereby gain a molecular understanding of how low-GI foods affect health by altering metabolic processes. This will give us a deeper insight into the metabolic processes that are necessary for maintaining normal glucose homeostasis
Detailed description
Using a cross-over design, 15 subjects with Mets will consume test meals containing four different porridges in randomized order. Blood samples will be collected over 2 hours after ingestion of test meals and 2 hours after ingestion of a standard second lunch meal served 4 hours after the test meals. The amount of porridge and the standard lunch are equivalent to 50 g available carbohydrate. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling and measurements of breath hydrogen will be used as a marker for colon fermentation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arabinoxylan | Experimental | Dietary Supplement: ArabinoxylanPorridge rich in arabinoxylan. 50 g available carbohydrate |
| rye kernels | Experimental | Dietary Supplement: Rye kernelPorridge made from rye kernels. 50 g available carbohydrate |
| arabinoxylan and rye kernels | Experimental | Dietary Supplement: Arabinoxylan and rye kernelsPorridge made of rye kernels and arabinoxylan. 50g available carbohydrate |
| semolina | Experimental | Dietary Supplement: SemolinaSemoline porridge. 50 g available carbohydrate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- fasting triglyceride (> 1,7 mmol/L),
- HDL-cholesterol: (Female:< 1,03 mmol/L; Male:< 1,29 mmol/L),
- blood pressure (≥ 130/85 mmHg) and
- fasting plasma glucose (≥ 5,6 mmol/L)). Subjects who are in medical treatment with lipid and blood pressure-lowering drugs can continue with their habitual treatment provided that the treatment is stable throughout the trial.
Key exclusion criteria (8 listed)
- fasting plasma glucose > 7,0 mmol/l,
- fasting plasma triglyceride > 5,0 mmol/l,
- blood pressure > 160/100 mmHg ,
- legal incapacity , endocrine, cardiovascular or kidney disease,
- BMI > 38kg/m2,
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 |
|---|---|---|
| ArabinoxylanAlso: Dietary fibre.Porridge rich in arabinoxylan | Dietary supplement | Arabinoxylan |
| Rye kernelAlso: Whole grain. Rye. Kernels.Porridge made of rye kernels | Dietary supplement | rye kernels |
| Arabinoxylan and rye kernelsAlso: dietary fibre. whole grain. rye kernels.Porridgde made of rye kernels and arabinoxylan | Dietary supplement | arabinoxylan and rye kernels |
| SemolinaAlso: Wheat.Semoline porridge. control meal. | Dietary supplement | semolina |
Primary outcome
Glucose response after second meal
Time frame: 2 hours
6 secondary outcomes
Plasma response after second meal
Time frame: 2 hours
Plasma response after test meal
Time frame: 2 hours
Breath hydrogen after second meal
Time frame: 2 hours
Breath hydrogen after testmeal
Time frame: 2 hours
Satiety feeling after second meal
Time frame: 2 hours
Satiety feeling after test meal
Time frame: 2 hours
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 19 Jun 2013.
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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.
Kjeld Hermansen, Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arabinoxylan, Rye kernel and Arabinoxylan and rye kernels in people with Metabolic Syndrome, run by Aarhus University Hospital at 1 site in Denmark.
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 5 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 19 Jun 2013. 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 Denmark. 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. 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?
Glucose response after second meal (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2013.