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Completed

NCT Number: NCT01154478

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

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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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University

Naples, 80131, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet rich in omega-3 fatty acids

Other

fish at least 3 times per week, large leaf vegetables

Diet rich in polyphenols

Other

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

Control diet

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)

diet rich in omega-3 and polyphenols

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

Primary outcomes

  1. incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction

    Time frame: 48 months

Secondary outcomes

  1. insulin sensitivity

    Time frame: 48 months

  2. plasma and adipose tissue adipokines

    Time frame: 48 months

  3. endothelial function

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: Etherpaths

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 1, 2010
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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