Metabolic SyndromeNCT01316354
Effect of Dietary Fibre and Whole Grain on the Metabolic Syndrome
A study testing Bread types 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?
- Bread types
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Dec 2011
- 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)
- 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
Show all 9Show fewer
- corticosteroid treatment
- alcohol or drug addiction
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arabinoxylan and Beta-glucan Compared With Whole Grain and Whole Meal Bread 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. The glycemic index (GI) describes in relative terms rise of blood glucose after ingestion of carbohydrate-rich food. Purified dietary fibre as β-glucan (BG) has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effects of arabinoxylans (AX), which constitute a substantial part of dietary fibre in cereal products, is limited. The investigators also lack a deeper understanding of the importance of whole grain (whole grain with whole kernels, and purified dietary fibre) in relation to Mets and T2DM.
Hypothesis: The composition of dietary carbohydrates can be designed so that they improve the glycemic and insulinaemic responses and increase satiety feeling. This can be detected in metabolic parameters in subjects with Mets.
Read more
The aim of our study is in subjects with Mets to compare the effect of acute consumption of bread rich in (a) purified AX, (b) purified BG, (c) rye bread with whole kernels (RK), with a (d) control group with consumption of white bread (WB).
The primary endpoint is GI. Secondary endpoints are the following items: glycemic load, insulin index, glucose, insulin, glucagon, inflammatory markers, incretins, rate of gastric emptying, and metabolomics. Also satiety feeling will be measured.
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, 12 subjects with Mets will consume test meals containing the four different bread types. Blood samples will be collected over 4,5 hours after ingestion of test meals containing around 145 g of each bread type, equivalent to 50 g available carbohydrate and 3 dl + 2 dl water on four different days in randomized order. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling and a subsequent meal will be served to estimate prospective food consumption.
- Conditions
- Metabolic Syndrome
- Being tested
- Bread types
- Keywords
- Arabinoxylan, Beta glucan, Whole grain, Dietary fibre, Metabolic syndrome, Glycemic index, 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.
Bread typesOther
Bread with 50 g available carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucan | Experimental | Bread with purified beta-glucan Receives: Other: Bread types |
| Rye kernels | Experimental | Rye bread with kernels Receives: Other: Bread types |
| White bread | Experimental | White bread Receives: Other: Bread types |
| Arabinoxylan | Experimental | Bread with Purified arabinoxylan Receives: Other: Bread types |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic index of breads with arabinoxylan and beta-glucan compared with whole grain breads in subject with the metabolic syndrome
Measured: 4,5 hours
Secondary outcomes (1)
Glycemic response and satiety
glycemic load, insulin index, glucose, insulin, incretins, inflammatory markers, rate of gastric emptying, metabolomics, and satiety feeling
Measured: 4,5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- NCT01316354
- Sponsor's protocol ID
- CERN-BioFunCarb
- Status last verified
- Apr 2012
- First submitted
- 15 Mar 2011
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krishnan S, Hendriks HF, Hartvigsen ML, de Graaf AA. Feed-forward neural network model for hunger and satiety related VAS score prediction. Theor Biol Med Model. 2016 Jul 7;13(1):17. doi: 10.1186/s12976-016-0043-4.
PubMed 27387922Nielsen KL, Hartvigsen ML, Hedemann MS, Laerke HN, Hermansen K, Bach Knudsen KE. Similar metabolic responses in pigs and humans to breads with different contents and compositions of dietary fibers: a metabolomics study. Am J Clin Nutr. 2014 Apr;99(4):941-9. doi: 10.3945/ajcn.113.074724. Epub 2014 Jan 29.
PubMed 24477039
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arabinoxylan and Beta-glucan Compared With Whole Grain and Whole Meal Bread in Subjects With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01316354
- Acronym / sponsor ID
- CERN-BioFunCarb
- Conditions
- Metabolic Syndrome
- Keywords
- Arabinoxylan, Beta glucan, Whole grain, Dietary fibre, Metabolic syndrome, Glycemic index, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Mar 2011 (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. The glycemic index (GI) describes in relative terms rise of blood glucose after ingestion of carbohydrate-rich food. Purified dietary fibre as β-glucan (BG) has been shown to reduce GI and affect levels of satiety hormones. In contrast, our knowledge of the physiological effects of arabinoxylans (AX), which constitute a substantial part of dietary fibre in cereal products, is limited. The investigators also lack a deeper understanding of the importance of whole grain (whole grain with whole kernels, and purified dietary fibre) in relation to Mets and T2DM.
Hypothesis: The composition of dietary carbohydrates can be designed so that they improve the glycemic and insulinaemic responses and increase satiety feeling. This can be detected in metabolic parameters in subjects with Mets.
The aim of our study is in subjects with Mets to compare the effect of acute consumption of bread rich in (a) purified AX, (b) purified BG, (c) rye bread with whole kernels (RK), with a (d) control group with consumption of white bread (WB).
The primary endpoint is GI. Secondary endpoints are the following items: glycemic load, insulin index, glucose, insulin, glucagon, inflammatory markers, incretins, rate of gastric emptying, and metabolomics. Also satiety feeling will be measured.
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, 12 subjects with Mets will consume test meals containing the four different bread types. Blood samples will be collected over 4,5 hours after ingestion of test meals containing around 145 g of each bread type, equivalent to 50 g available carbohydrate and 3 dl + 2 dl water on four different days in randomized order. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling and a subsequent meal will be served to estimate prospective food consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beta-glucan | Experimental | Other: Bread typesBread with purified beta-glucan |
| Rye kernels | Experimental | Other: Bread typesRye bread with kernels |
| White bread | Experimental | Other: Bread typesWhite bread |
| Arabinoxylan | Experimental | Other: Bread typesBread with Purified arabinoxylan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- central obesity (Female > 94 cm; Male > 80 cm) with two of the following: -- fasting triglyceride (> 1,7 mmol/L)
Key exclusion criteria (9 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
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 |
|---|---|---|
| Bread typesBread with 50 g available carbohydrate | Other | Arabinoxylan, Beta-glucan, Rye kernels, White bread |
Primary outcome
Glycaemic index of breads with arabinoxylan and beta-glucan compared with whole grain breads in subject with the metabolic syndrome
Time frame: 4,5 hours
1 secondary outcome
Glycemic response and satiety
Time frame: 4,5 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 Apr 2012.
- Derived from this study: PubMed 27387922Krishnan S, Hendriks HF, Hartvigsen ML, de Graaf AA. Feed-forward neural network model for hunger and satiety related VAS score prediction. Theor Biol Med Model. 2016 Jul 7;13(1):17. doi: 10.1186/s12976-016-0043-4.
- Derived from this study: PubMed 24477039Nielsen KL, Hartvigsen ML, Hedemann MS, Laerke HN, Hermansen K, Bach Knudsen KE. Similar metabolic responses in pigs and humans to breads with different contents and compositions of dietary fibers: a metabolomics study. Am J Clin Nutr. 2014 Apr;99(4):941-9. doi: 10.3945/ajcn.113.074724. Epub 2014 Jan 29.
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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 Bread types 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 4 inclusion and 9 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 Apr 2012. 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?
Glycaemic index of breads with arabinoxylan and beta-glucan compared with whole grain breads in subject with the metabolic syndrome (time frame: 4,5 hours). 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 NCT01316354, which also lists 2 linked publications.
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 Apr 2012.