Metabolic SyndromeNCT02148653
An Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Subjects
A study testing Multifunctional diet (MFD) in people with Metabolic Syndrome and Insulin Resistance, run by Lund University at 1 site in Sweden.
Trial summary
Main scientific question: A previous intervention with an anti-inflammatory multifunctional dietary portfolio (MFD) showed remarkable reductions in cardiometabolic (CM) risk markers compared with a well-designed control diet. Read more about this study
- Who is it for?
- Ages 50 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Insulin Resistance, Overweight
- What is being tested?
- Multifunctional diet (MFD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to Nov 2015
- 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 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal fasting blood glucose (max 6.1 mmol /l)
- BMI between 25 and 32 Kg/m2
Who cannot join
- treatment for hypercholesterolemia
- treatment for hypertension
- history of cardiovascular complications
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Functional Food Science Centre. Lund University Medicon Village
Lund, SE 223 81
About this study
Official title: Efficacy of an Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Overweight Subjects: Studies of Mechanisms Involving Metabolomics and Gut Microbiota Mapping
Main scientific question:
A previous intervention with an anti-inflammatory multifunctional dietary portfolio (MFD) showed remarkable reductions in cardiometabolic (CM) risk markers compared with a well-designed control diet. The study was performed under weight maintenance conditions in healthy subjects in a 4w crossover design (Tovar et al., 2012). MFD consumption also resulted in improved cognitive performance after 4 weeks (Nilsson et al., 2013).
Read more
The present project will further study the preventive potential of MFD, using its unique properties for identification of new biomarkers and to evaluate the potential role of alterations in the gut microbiota. MFD will be tested in healthy at risk subjects in a randomized parallel design in an eight-week intervention with the test or control diet, respectively, allowing for weight loss. Assessment of standard anthropometric/biochemical markers of CM risk, metabolomics analysis and appetite regulating hormone evaluation are also planned. Associations between the gut microbiota composition and measures of CM risk are also included. The project provides unique opportunities to identify mechanisms for the metabolic impact of MFD, for further exploitation in innovative food and/or dietary concepts.
Central hypothesis:
The CM-preventive potential of MFD may be boosted in a medium-term trial under conditions allowing for body weight reduction. Expected additional benefits may be recorded as reduced values for conventional CM-related parameters, markers of modified gut microbiota composition and specific changes in blood metabolite profiles.
Objectives:
- To further improve the effect of MFD on biochemical/anthropometric CM risk markers in healthy subjects by administering the diet under conditions allowing for weight reduction.
- To identify MFD-related changes in the gut microbiota associated with improved CM risk markers.
- To assess MFD-related modification in metabolic pathways, studied with a metabolomics approach, and to correlate them with conventional clinical outcomes, aiming to identify new markers of altered metabolic risk.
- Conditions
- Metabolic Syndrome, Insulin Resistance, Overweight
- Being tested
- Multifunctional diet (MFD), Control diet
- Keywords
- Cardiometabolic risk, Diet, Dietary prevention, Functional diet, Functional foods, Metabolic Syndrome, Overweight
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifunctional diet (MFD)Other
A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.
Control dietOther
A nutritionally well formulated diet that excludes the functional food items present in the MFD.
| Study group | Role | What they receive |
|---|---|---|
| Multifunctional diet (MFD) | Experimental | Subjects eat a diet designed according to the Nordic Nutrition Recommendations with the addition of important amounts of various functional food concepts: Low GI and GI-modulating food items; Natural antioxidant-rich items, Long chain omega-3 fatty acid-rich fish; Betaglucan-rich barley and oat food/drinks; Cholesterol-modulating foods. Receives: Other: Multifunctional diet (MFD) |
| Control diet | Experimental | Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD. Receives: Other: Control diet |
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
Start and End of the intervention arm
Measured: Time 0 and after week 8
Secondary outcomes (1)
Change from baseline in body weight after each dietary period
Start and End of the intervention arm
Measured: Week 0 and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionNov 2015
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova
- Responsible party
- Principal investigator, Juscelino Tovar, Lund University
- Investigators
- Juscelino Tovar, PhD, Study chair, Antidiabetic Food Centre & Functional Food Science Centre. Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148653
- Sponsor's protocol ID
- AFC-JT-MFD
- Status last verified
- Dec 2015
- First submitted
- 22 May 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tovar J, Nilsson A, Johansson M, Ekesbo R, Aberg AM, Johansson U, Bjorck I. A diet based on multiple functional concepts improves cardiometabolic risk parameters in healthy subjects. Nutr Metab (Lond). 2012 Apr 2;9:29. doi: 10.1186/1743-7075-9-29.
PubMed 22472183Nilsson A, Tovar J, Johansson M, Radeborg K, Bjorck I. A diet based on multiple functional concepts improves cognitive performance in healthy subjects. Nutr Metab (Lond). 2013 Jul 15;10:49. doi: 10.1186/1743-7075-10-49. eCollection 2013.
PubMed 23855966Tovar J, Johansson M, Bjorck I. A multifunctional diet improves cardiometabolic-related biomarkers independently of weight changes: an 8-week randomized controlled intervention in healthy overweight and obese subjects. Eur J Nutr. 2016 Oct;55(7):2295-306. doi: 10.1007/s00394-015-1039-2. Epub 2015 Sep 14.
PubMed 26370118Arroyo CB, Ocariz MG, Rogova O, Al-Majdoub M, Bjorck I, Tovar J, Spegel P. A randomized trial involving a multifunctional diet reveals systematic lipid remodeling and improvements in cardiometabolic risk factors in middle aged to aged adults. Front Nutr. 2023 Sep 14;10:1236153. doi: 10.3389/fnut.2023.1236153. eCollection 2023.
PubMed 37781111Marungruang N, Tovar J, Bjorck I, Hallenius FF. Improvement in cardiometabolic risk markers following a multifunctional diet is associated with gut microbial taxa in healthy overweight and obese subjects. Eur J Nutr. 2018 Dec;57(8):2927-2936. doi: 10.1007/s00394-017-1563-3. Epub 2017 Nov 2.
PubMed 29098426
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Overweight Subjects: Studies of Mechanisms Involving Metabolomics and Gut Microbiota Mapping
- ClinicalTrials.gov ID
- NCT02148653
- Acronym / sponsor ID
- AFC-JT-MFD
- Conditions
- Metabolic Syndrome, Insulin Resistance, Overweight
- Keywords
- Cardiometabolic risk, Diet, Dietary prevention, Functional diet, Functional foods, Metabolic Syndrome, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Vinnova
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 May 2014 (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.
Main scientific question:
A previous intervention with an anti-inflammatory multifunctional dietary portfolio (MFD) showed remarkable reductions in cardiometabolic (CM) risk markers compared with a well-designed control diet. The study was performed under weight maintenance conditions in healthy subjects in a 4w crossover design (Tovar et al., 2012). MFD consumption also resulted in improved cognitive performance after 4 weeks (Nilsson et al., 2013).
The present project will further study the preventive potential of MFD, using its unique properties for identification of new biomarkers and to evaluate the potential role of alterations in the gut microbiota. MFD will be tested in healthy at risk subjects in a randomized parallel design in an eight-week intervention with the test or control diet, respectively, allowing for weight loss. Assessment of standard anthropometric/biochemical markers of CM risk, metabolomics analysis and appetite regulating hormone evaluation are also planned. Associations between the gut microbiota composition and measures of CM risk are also included. The project provides unique opportunities to identify mechanisms for the metabolic impact of MFD, for further exploitation in innovative food and/or dietary concepts.
Central hypothesis:
The CM-preventive potential of MFD may be boosted in a medium-term trial under conditions allowing for body weight reduction. Expected additional benefits may be recorded as reduced values for conventional CM-related parameters, markers of modified gut microbiota composition and specific changes in blood metabolite profiles.
Objectives:
- To further improve the effect of MFD on biochemical/anthropometric CM risk markers in healthy subjects by administering the diet under conditions allowing for weight reduction.
- To identify MFD-related changes in the gut microbiota associated with improved CM risk markers.
- To assess MFD-related modification in metabolic pathways, studied with a metabolomics approach, and to correlate them with conventional clinical outcomes, aiming to identify new markers of altered metabolic risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifunctional diet (MFD) | Experimental | Other: Multifunctional diet (MFD)Subjects eat a diet designed according to the Nordic Nutrition Recommendations with the addition of important amounts of various functional food concepts: Low GI and GI-modulating food items; Natural antioxidant-rich items, Long chain omega-3 fatty acid-rich fish; Betaglucan-rich barley and oat food/drinks; Cholesterol-modulating foods. |
| Control diet | Experimental | Other: Control dietSubjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD. |
Who may qualify
- Ages
- 50 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal fasting blood glucose (max 6.1 mmol /l)
- BMI between 25 and 32 Kg/m2
Key exclusion criteria (3 listed)
- treatment for hypercholesterolemia
- treatment for hypertension
- history of cardiovascular complications
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 |
|---|---|---|
| Multifunctional diet (MFD)A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status. | Other | Multifunctional diet (MFD) |
| Control dietA nutritionally well formulated diet that excludes the functional food items present in the MFD. | Other | Control diet |
Primary outcome
Change from baseline in LDL cholesterol after each dietary period
Time frame: Time 0 and after week 8
Start and End of the intervention arm
1 secondary outcome
Change from baseline in body weight after each dietary period
Time frame: Week 0 and after 8 weeks
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 3 Dec 2015.
- Background: PubMed 22472183Tovar J, Nilsson A, Johansson M, Ekesbo R, Aberg AM, Johansson U, Bjorck I. A diet based on multiple functional concepts improves cardiometabolic risk parameters in healthy subjects. Nutr Metab (Lond). 2012 Apr 2;9:29. doi: 10.1186/1743-7075-9-29.
- Background: PubMed 23855966Nilsson A, Tovar J, Johansson M, Radeborg K, Bjorck I. A diet based on multiple functional concepts improves cognitive performance in healthy subjects. Nutr Metab (Lond). 2013 Jul 15;10:49. doi: 10.1186/1743-7075-10-49. eCollection 2013.
- Results publication: PubMed 26370118Tovar J, Johansson M, Bjorck I. A multifunctional diet improves cardiometabolic-related biomarkers independently of weight changes: an 8-week randomized controlled intervention in healthy overweight and obese subjects. Eur J Nutr. 2016 Oct;55(7):2295-306. doi: 10.1007/s00394-015-1039-2. Epub 2015 Sep 14.
- Derived from this study: PubMed 37781111Arroyo CB, Ocariz MG, Rogova O, Al-Majdoub M, Bjorck I, Tovar J, Spegel P. A randomized trial involving a multifunctional diet reveals systematic lipid remodeling and improvements in cardiometabolic risk factors in middle aged to aged adults. Front Nutr. 2023 Sep 14;10:1236153. doi: 10.3389/fnut.2023.1236153. eCollection 2023.
- Derived from this study: PubMed 29098426Marungruang N, Tovar J, Bjorck I, Hallenius FF. Improvement in cardiometabolic risk markers following a multifunctional diet is associated with gut microbial taxa in healthy overweight and obese subjects. Eur J Nutr. 2018 Dec;57(8):2927-2936. doi: 10.1007/s00394-017-1563-3. Epub 2017 Nov 2.
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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.
Juscelino Tovar, PhD study chair
Antidiabetic Food Centre & Functional Food Science Centre. 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 Multifunctional diet (MFD) 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 2 inclusion and 3 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 3 Dec 2015. 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: Time 0 and after week 8). 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 NCT02148653, 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 3 Dec 2015.