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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

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.

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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

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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B group

Diet rich in omega-3 fatty acids

Group Type EXPERIMENTAL

Diet rich in omega-3 fatty acids

Intervention Type OTHER

fish at least 3 times per week, large leaf vegetables

C group

Diet rich in polyphenols

Group Type EXPERIMENTAL

Diet rich in polyphenols

Intervention Type OTHER

extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee

D group

Diet rich in polyphenols and in omega-3 fatty acids

Group Type EXPERIMENTAL

diet rich in omega-3 and polyphenols

Intervention Type OTHER

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

A group (control group)

diet with low content of omega-3 fatty acids and polyphenols

Group Type PLACEBO_COMPARATOR

Control diet

Intervention Type OTHER

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)

Interventions

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Diet rich in omega-3 fatty acids

fish at least 3 times per week, large leaf vegetables

Intervention Type OTHER

Diet rich in polyphenols

extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee

Intervention Type OTHER

Control diet

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)

Intervention Type OTHER

diet rich in omega-3 and polyphenols

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

Intervention Type OTHER

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No