An Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Subjects
Condition: Metabolic Syndrome; Insulin Resistance; Overweight
MeSH terms: Overweight; Metabolic Syndrome; Insulin Resistance; Body Weight
Study type: Interventional

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.
    


Intervention name(s): Multifunctional diet (MFD); Control diet
Intervention type(s): Other; Other
Intervention description(s): A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.; A nutritionally well formulated diet that excludes the functional food items present in the MFD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiometabolic risk; Diet; Dietary prevention; Functional diet; Functional foods; Metabolic Syndrome; Overweight