Metabolic SyndromePhase 2SysdimetNCT00573781
Dietary Modulation of Gene Expression and Metabolic Pathways in Glucose Metabolism
A Phase 2 study testing Diet with increased intake of rye bread, berries and fish and Increased intake of whole grain and rye bread in people with Metabolic Syndrome and Obesity, run by Marjukka Kolehmainen at 1 site in Finland.
Trial summary
Professor Matti Uusitupa, University of Kuopio, Department of Clinical Nutrition (www.uku.fi) Docent Matej Oresic, VTT (www.vtt.fi) Ursula Schwab, PhD, Docent, Marjukka Kolehmainen, PhD, Docent, Leena Pulkkinen, PhD, Docent, David Laaksonen, MD, PhD, MPH, Docent, Kaisa Poutanen, DSc (Tech), Research Professor ABSTRACT… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity, Impaired Glucose Tolerance
- What is being tested?
- Diet with increased intake of rye bread, berries and fish and Increased intake of whole grain and rye bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 2
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- impaired glucose tolerance (oral glucose tolerance test with 2-h glucose concentration 7,8-11,0 mmol/l) OR
- impaired fasting glucose fasting plasma glucose concentration 5,6-6,9 mmol/l = IFG)
- and two of the criteria for metabolic syndrome:
- BMI 26-39 kg/m2
- Waist circumference > 102 cm (men) or > 88 cm (women)
- hypertriglyceridemia (fasting serum triglyceride conc > 1,7 mmol/l),
- HDL-cholesterol (fasting serum HDL conc < 1,0 mmol/l for men and < 1,3 mmol/l for women)
- Blood pressure ≥ 130/≥ 85 mmHg
Who cannot join
- BMI > 40 kg/m2
- fasting serum triglyceride conc > 3.5 mmol/l
- fasting serum cholesterol > 8 mmol/l
- type 1 or 2 diabetes
- abnormal liver, kidney or thyroid function
- large alcohol intake (women >16, men > 24 doses (4cl liquor or equivalent) during week)
Show all 9Show fewer
- inflammatory bowel disease
- disease that prevents participation
- neuroleptic neuroleptic cortisone medication
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Kuopio, Department of Clinical Nutrition
Kuopio, 70211
About this study
Official title: Systems Biology Approach to Understand Dietary Modulation of Gene Expression and Metabolic Pathways in Subjects With Abnormal Glucose Metabolism (Sysdimet)
Professor Matti Uusitupa, University of Kuopio, Department of Clinical Nutrition (www.uku.fi) Docent Matej Oresic, VTT (www.vtt.fi) Ursula Schwab, PhD, Docent, Marjukka Kolehmainen, PhD, Docent, Leena Pulkkinen, PhD, Docent, David Laaksonen, MD, PhD, MPH, Docent, Kaisa Poutanen, DSc (Tech), Research Professor
ABSTRACT
Read more
The metabolic syndrome (MS) and type 2 diabetes (T2DM) are the most important health problems worldwide. In Finland the prevalence of T2DM is 12-15% among middle-aged people. The prevalence of less marked disturbances in glucose metabolism and MS is 30-40%. Because MS and T2DM are important risk factors for cardiovascular diseases (CVD), the leading cause of death in western countries, all efforts to reverse the epidemic increase in the incidence of MS and T2DM are warranted. The investigators have focused for years on the prevention and non-pharmacological treatment of T2DM and its complications including studies on genetic regulation of glucose and lipid metabolism after dietary modifications. In the investigators' recent projects, the investigators have studied the effects of long-term dietary interventions on gene expression profiles of fat tissue in subjects who are at risk of T2DM. The ultimate goal of these projects has been to identify genes and gene clusters and their biological pathways that respond to dietary modification and modulate glucose and lipid metabolism, and to develop dietary strategies for prevention of T2DM. The main goal of this project is to find nutrition related early biomarkers for progression of MS to T2DM by using modern technologies of systems biology (transcriptomics, metabolomics) of carefully conducted dietary interventions involving subjects with MS. The data will be analysed by using bioinformatics. The investigators reflect these new data to well-known risk factors for T2DM and CVD, e.g., insulin sensitivity, insulin secretion, serum lipids and inflammatory factors among others. In addition to interventions conducted earlier, a new intervention with a whole grain-berry-fish diet and a whole grain diet compared to a control diet with refined foods will be performed. The aim is to increase the investigators' understanding on the synergistic effects of these foods, because the investigators' previous interventions have shown that these individual foods have beneficial effects on glucose and lipid metabolism. On the contrary, diets with refined foods may be harmful in long-term due to its high insulin response, which may through chronic stress lead to both insulin resistance and beta-cell damage.
The significance of this project is to increase understanding of the pathophysiology of MS, T2DM and CVD in physiological, cellular and genetic systems, which may lead to more effective and individualised strategies for treatment and prevention, and better identification of high-risk individuals responsive to specific dietary modifications. Increasing knowledge of dietary factors involved in the progression of MS to T2DM and CVD offers new opportunities to individually tailored diets in the management and prevention of these disorders. The results will also be beneficial for the food industry in developing new functional foods. These results and actions may help delay or even stop the epidemic of MS and T2DM and their negative effect on public health currently seen in Finland and worldwide.
- Being tested
- Diet with increased intake of rye bread, berries and fish, Increased intake of whole grain and rye bread, Control diet with decreased intake of rye bread, berries and fish
- Keywords
- Systems biology, Nutrigenomics, Metabolomics, Gene expression, Fat tissue, Peripheral mononuclear cells, Gene clusters, Gene expression profiles, Personal diets, Metabolic syndrome, Type 2 Diabetes, Atherosclerosis
- Medical subject headings
- Metabolic Syndrome, Obesity, Glucose Intolerance, Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet with increased intake of rye bread, berries and fishDietary supplement
Dietary modification with commercial food items
Increased intake of whole grain and rye breadDietary supplement
Dietary modification with commercial food items
Control diet with decreased intake of rye bread, berries and fishDietary supplement
Dietary modification with commercial food items
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Diet with increased intake of rye bread, berries and fish Receives: Dietary Supplement: Diet with increased intake of rye bread, berries and fish |
| B | Experimental | Increased intake of whole grain and rye bread Receives: Dietary Supplement: Increased intake of whole grain and rye bread |
| C | Active comparator | Control diet with decreased intake of rye bread, berries and fish Receives: Dietary Supplement: Control diet with decreased intake of rye bread, berries and fish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles
Measured: By 2010
Secondary outcomes (1)
Interaction between the diet and genetic factors within treatment groups
Measured: By 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marjukka Kolehmainen
- Sponsor type
- University, hospital or other
- Collaborators
- VTT Technical Research Centre, Finland, Wageningen University
- Responsible party
- Sponsor-investigator, Marjukka Kolehmainen, University of Eastern Finland
- Investigators
- Matti IJ Uusitupa, professor, rector, Study director, University of Kuopio, Department of Clinical Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573781
- Sponsor's protocol ID
- 56/2007
- Other IDs
- 117844 by Finnish Academy
- Acronym
- Sysdimet
- Status last verified
- Apr 2012
- First submitted
- 13 Dec 2007
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Karkkainen O, Lankinen MA, Vitale M, Jokkala J, Leppanen J, Koistinen V, Lehtonen M, Giacco R, Rosa-Sibakov N, Micard V, Rivellese AAA, Schwab U, Mykkanen H, Uusitupa M, Kolehmainen M, Riccardi G, Poutanen K, Auriola S, Hanhineva K. Diets rich in whole grains increase betainized compounds associated with glucose metabolism. Am J Clin Nutr. 2018 Nov 1;108(5):971-979. doi: 10.1093/ajcn/nqy169.
PubMed 30256894Lankinen MA, Hanhineva K, Kolehmainen M, Lehtonen M, Auriola S, Mykkanen H, Poutanen K, Schwab U, Uusitupa M. CMPF does not associate with impaired glucose metabolism in individuals with features of metabolic syndrome. PLoS One. 2015 Apr 15;10(4):e0124379. doi: 10.1371/journal.pone.0124379. eCollection 2015.
PubMed 25874636Hanhineva K, Lankinen MA, Pedret A, Schwab U, Kolehmainen M, Paananen J, de Mello V, Sola R, Lehtonen M, Poutanen K, Uusitupa M, Mykkanen H. Nontargeted metabolite profiling discriminates diet-specific biomarkers for consumption of whole grains, fatty fish, and bilberries in a randomized controlled trial. J Nutr. 2015 Jan;145(1):7-17. doi: 10.3945/jn.114.196840. Epub 2014 Nov 12.
PubMed 25527657Lankinen M, Kolehmainen M, Jaaskelainen T, Paananen J, Joukamo L, Kangas AJ, Soininen P, Poutanen K, Mykkanen H, Gylling H, Oresic M, Jauhiainen M, Ala-Korpela M, Uusitupa M, Schwab U. Effects of whole grain, fish and bilberries on serum metabolic profile and lipid transfer protein activities: a randomized trial (Sysdimet). PLoS One. 2014 Feb 28;9(2):e90352. doi: 10.1371/journal.pone.0090352. eCollection 2014.
PubMed 24587337Lappi J, Salojarvi J, Kolehmainen M, Mykkanen H, Poutanen K, de Vos WM, Salonen A. Intake of whole-grain and fiber-rich rye bread versus refined wheat bread does not differentiate intestinal microbiota composition in Finnish adults with metabolic syndrome. J Nutr. 2013 May;143(5):648-55. doi: 10.3945/jn.112.172668. Epub 2013 Mar 20.
PubMed 23514765Lankinen M, Schwab U, Kolehmainen M, Paananen J, Poutanen K, Mykkanen H, Seppanen-Laakso T, Gylling H, Uusitupa M, Oresic M. Whole grain products, fish and bilberries alter glucose and lipid metabolism in a randomized, controlled trial: the Sysdimet study. PLoS One. 2011;6(8):e22646. doi: 10.1371/journal.pone.0022646. Epub 2011 Aug 25.
PubMed 21901116de Mello VD, Schwab U, Kolehmainen M, Koenig W, Siloaho M, Poutanen K, Mykkanen H, Uusitupa M. A diet high in fatty fish, bilberries and wholegrain products improves markers of endothelial function and inflammation in individuals with impaired glucose metabolism in a randomised controlled trial: the Sysdimet study. Diabetologia. 2011 Nov;54(11):2755-67. doi: 10.1007/s00125-011-2285-3. Epub 2011 Aug 26.
PubMed 21870174
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology Approach to Understand Dietary Modulation of Gene Expression and Metabolic Pathways in Subjects With Abnormal Glucose Metabolism (Sysdimet)
- ClinicalTrials.gov ID
- NCT00573781
- Acronym / sponsor ID
- Sysdimet / 56/2007
- Keywords
- Systems biology, Nutrigenomics, Metabolomics, Gene expression, Fat tissue, Peripheral mononuclear cells, Gene clusters, Gene expression profiles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Marjukka KolehmainenUniversity, hospital or other
- Collaborators
- VTT Technical Research Centre, Finland, Wageningen University
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Dec 2007 (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.
Professor Matti Uusitupa, University of Kuopio, Department of Clinical Nutrition (www.uku.fi) Docent Matej Oresic, VTT (www.vtt.fi) Ursula Schwab, PhD, Docent, Marjukka Kolehmainen, PhD, Docent, Leena Pulkkinen, PhD, Docent, David Laaksonen, MD, PhD, MPH, Docent, Kaisa Poutanen, DSc (Tech), Research Professor
ABSTRACT
The metabolic syndrome (MS) and type 2 diabetes (T2DM) are the most important health problems worldwide. In Finland the prevalence of T2DM is 12-15% among middle-aged people. The prevalence of less marked disturbances in glucose metabolism and MS is 30-40%. Because MS and T2DM are important risk factors for cardiovascular diseases (CVD), the leading cause of death in western countries, all efforts to reverse the epidemic increase in the incidence of MS and T2DM are warranted. The investigators have focused for years on the prevention and non-pharmacological treatment of T2DM and its complications including studies on genetic regulation of glucose and lipid metabolism after dietary modifications. In the investigators' recent projects, the investigators have studied the effects of long-term dietary interventions on gene expression profiles of fat tissue in subjects who are at risk of T2DM. The ultimate goal of these projects has been to identify genes and gene clusters and their biological pathways that respond to dietary modification and modulate glucose and lipid metabolism, and to develop dietary strategies for prevention of T2DM. The main goal of this project is to find nutrition related early biomarkers for progression of MS to T2DM by using modern technologies of systems biology (transcriptomics, metabolomics) of carefully conducted dietary interventions involving subjects with MS. The data will be analysed by using bioinformatics. The investigators reflect these new data to well-known risk factors for T2DM and CVD, e.g., insulin sensitivity, insulin secretion, serum lipids and inflammatory factors among others. In addition to interventions conducted earlier, a new intervention with a whole grain-berry-fish diet and a whole grain diet compared to a control diet with refined foods will be performed. The aim is to increase the investigators' understanding on the synergistic effects of these foods, because the investigators' previous interventions have shown that these individual foods have beneficial effects on glucose and lipid metabolism. On the contrary, diets with refined foods may be harmful in long-term due to its high insulin response, which may through chronic stress lead to both insulin resistance and beta-cell damage.
The significance of this project is to increase understanding of the pathophysiology of MS, T2DM and CVD in physiological, cellular and genetic systems, which may lead to more effective and individualised strategies for treatment and prevention, and better identification of high-risk individuals responsive to specific dietary modifications. Increasing knowledge of dietary factors involved in the progression of MS to T2DM and CVD offers new opportunities to individually tailored diets in the management and prevention of these disorders. The results will also be beneficial for the food industry in developing new functional foods. These results and actions may help delay or even stop the epidemic of MS and T2DM and their negative effect on public health currently seen in Finland and worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Diet with increased intake of rye bread, berries and fishDiet with increased intake of rye bread, berries and fish |
| B | Experimental | Dietary Supplement: Increased intake of whole grain and rye breadIncreased intake of whole grain and rye bread |
| C | Active comparator | Dietary Supplement: Control diet with decreased intake of rye bread, berries and fishControl diet with decreased intake of rye bread, berries and fish |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- impaired glucose tolerance (oral glucose tolerance test with 2-h glucose concentration 7,8-11,0 mmol/l) OR
- impaired fasting glucose fasting plasma glucose concentration 5,6-6,9 mmol/l = IFG)
- and two of the criteria for metabolic syndrome:
- BMI 26-39 kg/m2
- Waist circumference > 102 cm (men) or > 88 cm (women)
Key exclusion criteria (9 listed)
- BMI > 40 kg/m2
- fasting serum triglyceride conc > 3.5 mmol/l
- fasting serum cholesterol > 8 mmol/l
- type 1 or 2 diabetes
- abnormal liver, kidney or thyroid function
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 |
|---|---|---|
| Diet with increased intake of rye bread, berries and fishDietary modification with commercial food items | Dietary supplement | A |
| Increased intake of whole grain and rye breadDietary modification with commercial food items | Dietary supplement | B |
| Control diet with decreased intake of rye bread, berries and fishDietary modification with commercial food items | Dietary supplement | C |
Primary outcome
Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles
Time frame: By 2010
1 secondary outcome
Interaction between the diet and genetic factors within treatment groups
Time frame: By 2010
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 17 Apr 2012.
- Derived from this study: PubMed 30256894Karkkainen O, Lankinen MA, Vitale M, Jokkala J, Leppanen J, Koistinen V, Lehtonen M, Giacco R, Rosa-Sibakov N, Micard V, Rivellese AAA, Schwab U, Mykkanen H, Uusitupa M, Kolehmainen M, Riccardi G, Poutanen K, Auriola S, Hanhineva K. Diets rich in whole grains increase betainized compounds associated with glucose metabolism. Am J Clin Nutr. 2018 Nov 1;108(5):971-979. doi: 10.1093/ajcn/nqy169.
- Derived from this study: PubMed 25874636Lankinen MA, Hanhineva K, Kolehmainen M, Lehtonen M, Auriola S, Mykkanen H, Poutanen K, Schwab U, Uusitupa M. CMPF does not associate with impaired glucose metabolism in individuals with features of metabolic syndrome. PLoS One. 2015 Apr 15;10(4):e0124379. doi: 10.1371/journal.pone.0124379. eCollection 2015.
- Derived from this study: PubMed 25527657Hanhineva K, Lankinen MA, Pedret A, Schwab U, Kolehmainen M, Paananen J, de Mello V, Sola R, Lehtonen M, Poutanen K, Uusitupa M, Mykkanen H. Nontargeted metabolite profiling discriminates diet-specific biomarkers for consumption of whole grains, fatty fish, and bilberries in a randomized controlled trial. J Nutr. 2015 Jan;145(1):7-17. doi: 10.3945/jn.114.196840. Epub 2014 Nov 12.
- Derived from this study: PubMed 24587337Lankinen M, Kolehmainen M, Jaaskelainen T, Paananen J, Joukamo L, Kangas AJ, Soininen P, Poutanen K, Mykkanen H, Gylling H, Oresic M, Jauhiainen M, Ala-Korpela M, Uusitupa M, Schwab U. Effects of whole grain, fish and bilberries on serum metabolic profile and lipid transfer protein activities: a randomized trial (Sysdimet). PLoS One. 2014 Feb 28;9(2):e90352. doi: 10.1371/journal.pone.0090352. eCollection 2014.
- Derived from this study: PubMed 23514765Lappi J, Salojarvi J, Kolehmainen M, Mykkanen H, Poutanen K, de Vos WM, Salonen A. Intake of whole-grain and fiber-rich rye bread versus refined wheat bread does not differentiate intestinal microbiota composition in Finnish adults with metabolic syndrome. J Nutr. 2013 May;143(5):648-55. doi: 10.3945/jn.112.172668. Epub 2013 Mar 20.
- Derived from this study: PubMed 21901116Lankinen M, Schwab U, Kolehmainen M, Paananen J, Poutanen K, Mykkanen H, Seppanen-Laakso T, Gylling H, Uusitupa M, Oresic M. Whole grain products, fish and bilberries alter glucose and lipid metabolism in a randomized, controlled trial: the Sysdimet study. PLoS One. 2011;6(8):e22646. doi: 10.1371/journal.pone.0022646. Epub 2011 Aug 25.
- Derived from this study: PubMed 21870174de Mello VD, Schwab U, Kolehmainen M, Koenig W, Siloaho M, Poutanen K, Mykkanen H, Uusitupa M. A diet high in fatty fish, bilberries and wholegrain products improves markers of endothelial function and inflammation in individuals with impaired glucose metabolism in a randomised controlled trial: the Sysdimet study. Diabetologia. 2011 Nov;54(11):2755-67. doi: 10.1007/s00125-011-2285-3. Epub 2011 Aug 26.
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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.
Matti IJ Uusitupa, professor, rector study director
University of Kuopio, Department of Clinical Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diet with increased intake of rye bread, berries and fish and Increased intake of whole grain and rye bread in people with Metabolic Syndrome and Obesity, run by Marjukka Kolehmainen at 1 site in Finland.
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 8 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 17 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 Finland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles (time frame: By 2010). 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 NCT00573781, which also lists 7 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 17 Apr 2012.