An Antiinflammatory Diet as Modulator of Cardiometabolic Risk and Body Weight in Healthy Subjects

Study Overview
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Brief Summary
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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: 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.

Official Title
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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

Conditions
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Metabolic Syndrome, Insulin Resistance, Overweight

Intervention / Treatment
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* Other: Multifunctional diet (MFD)
* Other: Control diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifunctional diet (MFD)<br>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. | Other: Multifunctional diet (MFD)<br>* A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.<br>|
| Experimental: Control diet<br>Subjects eat a diet designed according to the Nordic Nutrition Recommendations but lacking the functional items included in the MFD. | Other: Control diet<br>* A nutritionally well formulated diet that excludes the functional food items present in the MFD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Cardiometabolic risk, Diet, Dietary prevention, Functional diet, Functional foods, Metabolic Syndrome