Metabolic SyndromeNCT01527253
Effect of a Synergistic Food Basket on Metabolic Syndrome Risk
A study testing Synergistic food basket in people with Metabolic Syndrome and Insulin Resistance, run by Lund University at 1 site in Sweden.
Trial summary
The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance
- What is being tested?
- Synergistic food basket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Dec 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 25 and 32 kg/m2
Who cannot join
- Fasting blood glucose > 6.1 mmol/L
- Medication for high blood pressure and/or elevated blood cholesterol
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Antidiabetic Food Centre, Chemical Centre. Lund University
Lund, Skåne County, 221 00
About this study
Official title: Effects of a Synergistic Food Basket on Markers of Metabolic Syndrome Risk in Healthy Mature Women
The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. It is hypothesized that the medium-term consumption of a diet combining low GI-prebiotic foods may positively influence various biomarkers associated with the risk for developing metabolic syndrome and cardiometabolic disease. Also, the combination of functional mechanisms are expected to result in synergistic effects.
Read the detailed description
The intervention is carried out in healthy women following a randomized crossover design in which an "active" (functional") diet is compared with a control diet formulated in agreement with the Nordic Dietary Recommendations but lacking the functional ingredients of the active regime.
The active diet supplies important daily amounts of dried legumes and wholegrain cereal products.
Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period. Subjects are encouraged to maintain a stable body weight under the whole trial.
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Being tested
- Synergistic food basket
- Keywords
- Cardiometabolic risk, Metabolic syndrome, Prebiotics, Legumes, Wholegrain cereal, Functional diet, Low glycemic index diet
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synergistic food basketOther
A low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease
| Study group | Role | What they receive |
|---|---|---|
| Active Diet | Experimental | Subjects eat a diet designed according to the Nordic Dietary Recommendations containing important amounts of specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics) Receives: Other: Synergistic food basket |
| Control diet | Experimental | Subjects eat a diet designed according to the Nordic Dietary Recommendations but lacks the specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics). Receives: Other: Synergistic food basket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in LDL cholesterol after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Secondary outcomes (11)
Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma triglycerides after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting CRP after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PYY after each dietary period
Satiety signalling hormone PYY
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma insulin after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma glucose after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PAI-1 after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in BMI after each dietary period
Body Mass Index
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in blood pressure after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in HOMA-IR after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in waist circumference after each dietary period
Measured: Week 0 and after 4 weeks (Start and End of the intervention arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Lund UniversityThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Anti-Diabetic Food Centre
- Responsible party
- Principal investigator, Juscelino Tovar, Lund University
- Investigators
- Inger Björck, PhD Prof., Study chair, Antidiabetic Food Centre, Lund UniversityJuscelino Tovar, PhD, Study director, Antidiabetic Food Centre, Lund UniversityAnne Nilsson, PhD, Principal investigator, Lund UniversityMaria Johansson, PhD, Principal investigator, Antidiabetic Food Centre, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527253
- Sponsor's protocol ID
- AFC-Food Basket
- Status last verified
- May 2014
- First submitted
- 31 Jan 2012
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsson A, Ostman E, Preston T, Bjorck I. Effects of GI vs content of cereal fibre of the evening meal on glucose tolerance at a subsequent standardized breakfast. Eur J Clin Nutr. 2008 Jun;62(6):712-20. doi: 10.1038/sj.ejcn.1602784. Epub 2007 May 23.
PubMed 17522615Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.
PubMed 18356328Nilsson AC, Ostman EM, Granfeldt Y, Bjorck IM. Effect of cereal test breakfasts differing in glycemic index and content of indigestible carbohydrates on daylong glucose tolerance in healthy subjects. Am J Clin Nutr. 2008 Mar;87(3):645-54. doi: 10.1093/ajcn/87.3.645.
PubMed 18326603Liljeberg HG, Akerberg AK, Bjorck IM. Effect of the glycemic index and content of indigestible carbohydrates of cereal-based breakfast meals on glucose tolerance at lunch in healthy subjects. Am J Clin Nutr. 1999 Apr;69(4):647-55. doi: 10.1093/ajcn/69.4.647.
PubMed 10197565Tovar J, Nilsson A, Johansson M, Bjorck I. Combining functional features of whole-grain barley and legumes for dietary reduction of cardiometabolic risk: a randomised cross-over intervention in mature women. Br J Nutr. 2014 Feb;111(4):706-14. doi: 10.1017/S000711451300305X. Epub 2013 Sep 24.
PubMed 24063257
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Synergistic Food Basket on Markers of Metabolic Syndrome Risk in Healthy Mature Women
- ClinicalTrials.gov ID
- NCT01527253
- Acronym / sponsor ID
- AFC-Food Basket
- Conditions
- Metabolic Syndrome, Insulin Resistance
- Keywords
- Cardiometabolic risk, Metabolic syndrome, Prebiotics, Legumes, Wholegrain cereal, Functional diet, Low glycemic index diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Anti-Diabetic Food Centre
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Feb 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.
The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. It is hypothesized that the medium-term consumption of a diet combining low GI-prebiotic foods may positively influence various biomarkers associated with the risk for developing metabolic syndrome and cardiometabolic disease. Also, the combination of functional mechanisms are expected to result in synergistic effects.
Detailed description
The intervention is carried out in healthy women following a randomized crossover design in which an "active" (functional") diet is compared with a control diet formulated in agreement with the Nordic Dietary Recommendations but lacking the functional ingredients of the active regime.
The active diet supplies important daily amounts of dried legumes and wholegrain cereal products.
Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period. Subjects are encouraged to maintain a stable body weight under the whole trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Diet | Experimental | Other: Synergistic food basketSubjects eat a diet designed according to the Nordic Dietary Recommendations containing important amounts of specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics) |
| Control diet | Experimental | Other: Synergistic food basketSubjects eat a diet designed according to the Nordic Dietary Recommendations but lacks the specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI between 25 and 32 kg/m2
Key exclusion criteria (2 listed)
- Fasting blood glucose > 6.1 mmol/L
- Medication for high blood pressure and/or elevated blood cholesterol
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 |
|---|---|---|
| Synergistic food basketA low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease | Other | Active Diet, Control diet |
Primary outcome
Change from baseline in LDL cholesterol after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
11 secondary outcomes
Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma triglycerides after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting CRP after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PYY after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma insulin after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma glucose after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in fasting plasma PAI-1 after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in BMI after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in blood pressure after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in HOMA-IR after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
Change from baseline in waist circumference after each dietary period
Time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)
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 23 May 2014.
- Background: PubMed 17522615Nilsson A, Ostman E, Preston T, Bjorck I. Effects of GI vs content of cereal fibre of the evening meal on glucose tolerance at a subsequent standardized breakfast. Eur J Clin Nutr. 2008 Jun;62(6):712-20. doi: 10.1038/sj.ejcn.1602784. Epub 2007 May 23.
- Background: PubMed 18356328Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.
- Background: PubMed 18326603Nilsson AC, Ostman EM, Granfeldt Y, Bjorck IM. Effect of cereal test breakfasts differing in glycemic index and content of indigestible carbohydrates on daylong glucose tolerance in healthy subjects. Am J Clin Nutr. 2008 Mar;87(3):645-54. doi: 10.1093/ajcn/87.3.645.
- Background: PubMed 10197565Liljeberg HG, Akerberg AK, Bjorck IM. Effect of the glycemic index and content of indigestible carbohydrates of cereal-based breakfast meals on glucose tolerance at lunch in healthy subjects. Am J Clin Nutr. 1999 Apr;69(4):647-55. doi: 10.1093/ajcn/69.4.647.
- Results publication: PubMed 24063257Tovar J, Nilsson A, Johansson M, Bjorck I. Combining functional features of whole-grain barley and legumes for dietary reduction of cardiometabolic risk: a randomised cross-over intervention in mature women. Br J Nutr. 2014 Feb;111(4):706-14. doi: 10.1017/S000711451300305X. Epub 2013 Sep 24.
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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.
Inger Björck, PhD Prof. study chair
Antidiabetic Food Centre, Lund University
Juscelino Tovar, PhD study director
Antidiabetic Food Centre, Lund University
Anne Nilsson, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synergistic food basket in people with Metabolic Syndrome and Insulin Resistance, run by Lund University at 1 site in Sweden.
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 1 inclusion and 2 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 23 May 2014. 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 Sweden. 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?
Change from baseline in LDL cholesterol after each dietary period (time frame: Week 0 and after 4 weeks (Start and End of the intervention arm)). 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 NCT01527253, which also lists 5 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 23 May 2014.