Insulin Resistance, Metabolic Syndrome, Overweight
Conditions
Keywords
Cardiometabolic risk, Diet, Dietary prevention, Functional diet, Functional foods, Metabolic Syndrome, Overweight
Brief 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. 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.
Interventions
OTHERMultifunctional diet (MFD)
A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.
OTHERControl diet
A nutritionally well formulated diet that excludes the functional food items present in the MFD.
Sponsors
Vinnova
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 73 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal fasting blood glucose (max 6.1 mmol /l) * BMI between 25 and 32 Kg/m2
Exclusion criteria
* treatment for hypercholesterolemia * treatment for hypertension * history of cardiovascular complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in LDL cholesterol after each dietary period | Time 0 and after week 8 | Start and End of the intervention arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body weight after each dietary period | Week 0 and after 8 weeks | Start and End of the intervention arm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in circulating triglycerides | Week 0 and after 8 weeks | Start and End of the intervention arm |
| Change from base line in the diversity of gut microbiota | Week 0 and after 8 weeks | Start and End of the intervention arm |
Countries
Sweden
Outcome results
None listed