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| Name | Class |
|---|---|
| Vinnova | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control diet | Experimental | Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in LDL cholesterol after each dietary period | Start and End of the intervention arm | Time 0 and after week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight after each dietary period | Start and End of the intervention arm | Week 0 and after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in circulating triglycerides | Start and End of the intervention arm | Week 0 and after 8 weeks |
| Change from base line in the diversity of gut microbiota | Start and End of the intervention arm |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juscelino Tovar, PhD | Antidiabetic Food Centre & Functional Food Science Centre. Lund University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Functional Food Science Centre. Lund University Medicon Village | Lund | SE 223 81 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22472183 | Background | 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. | |
| 23855966 | Background | Nilsson 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. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Control diet | Other | A nutritionally well formulated diet that excludes the functional food items present in the MFD. |
|
| Week 0 and after 8 weeks |
| 26370118 | Result | Tovar 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. |
| 37781111 | Derived | Arroyo 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. |
| 29098426 | Derived | Marungruang 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. |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |