Effects of Dietary Polyphenols and ω-3 Fatty Acids on Cardiovascular Risk Factors in High Risk Subjects

Study Overview
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Brief Summary
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The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk.

Detailed Description
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Fish consumption is associated with a lower cardiovascular risk and dietary supplementation with ω-3 fatty acids reduces plasma triglyceride levels. The mechanisms of action of ω-3 fatty acids are currently not completely understood. It has been hypothesized that polyunsaturated ω-3 fatty acids beneficial effects may be mediated through their ability to facilitate plasmalogen replenishment. Polyphenols are associated with beneficial effects on some cardiovascular risk factors, in particular with a reduced lipid oxidation. Less data are available on their effects on lipid metabolism. Recent data suggest that these effects could be mediated by changes in plasmalogen levels. The effects on lipid metabolism of combining the two dietary approaches (ω-3 fatty acids and polyphenols) are not known. While developed populations live for the most part in the postprandial state, much of the information on lipid metabolism refers to fasting condition. Dietary Intervention Study Design Eighty people at high cardiovascular risk randomly assigned to one of the four different nutritional 8-week interventions: (A) Control diet poor in omega-3 fatty acids and polyphenols (B) Diet rich in omega-3 fatty acids (C) Diet rich in polyphenols (D) Diet rich in omega-3 fatty acids and polyphenols

Official Title
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Effects of Polyphenols and Omega-3 Fatty Acids on Cardiovascular Rik Factors (Focusing on Postprandial Lipids Metabolism) in Subjects With High Risk for Type 2 Diabetes and Cardiovascular Diseases

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Diet rich in omega-3 fatty acids
* Other: Diet rich in polyphenols
* Other: Control diet
* Other: diet rich in omega-3 and polyphenols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bmi >25<35 kg/m2 High waist circumference (men >102 cm, women >88 cm) + one the following components of metabolic syndrome : Fasting plasma triglycerides ≥150 mg/dl Fasting HDL-col <40 mg/dl (men) and <50 mg/dl (women) Fasting plasma glucose 100-125 mg/dl Exclusion Criteria: Fasting plasma triglycerides ≥400 mg/dl and cholesterol >270 mg/dl Cardiovascular events (AMI and/or stroke) in the last 6 months Diabetes mellitus Regular intensive physical activity Kidney (serum creatinine >1.7 mg/dl) and liver (transaminases >double) Hypolipidemic or antinflammatory drugs Anemia (Hb <12 g/dl) or any other chronic disease

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: B group<br>Diet rich in omega-3 fatty acids | Other: Diet rich in omega-3 fatty acids<br>* fish at least 3 times per week, large leaf vegetables<br>|
| Experimental: C group<br>Diet rich in polyphenols | Other: Diet rich in polyphenols<br>* extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee<br>|
| Experimental: D group<br>Diet rich in polyphenols and in omega-3 fatty acids | Other: diet rich in omega-3 and polyphenols<br>* Fish at least 3 times x week,large leaf vegetables + extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee<br>|
| Placebo Comparator: A group (control group)<br>diet with low content of omega-3 fatty acids and polyphenols | Other: Control diet<br>* low content of omega-3 fatty acids and polyphenols (low intake of fish, nuts and legumes,oil rich in monounsaturated fatty acids, vegetables and fruits poor in polyphenols)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity |  | 48 months | 
| plasma and adipose tissue adipokines |  | 48 months | 
| endothelial function |  | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyphenols omega-3 postprandial lipemia adipose tissue