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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University
ClinicalTrials.gov Identifier:
NCT01154478
First received: June 14, 2010
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Other: Diet rich in omega-3 fatty acids
Other: Diet rich in polyphenols
Other: Control diet
Other: diet rich in omega-3 and polyphenols

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin sensitivity [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • plasma and adipose tissue adipokines [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • endothelial function [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B group
Diet rich in omega-3 fatty acids
Other: Diet rich in omega-3 fatty acids
fish at least 3 times per week, large leaf vegetables
Experimental: C group
Diet rich in polyphenols
Other: Diet rich in polyphenols
extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
Experimental: D group
Diet rich in polyphenols and in omega-3 fatty acids
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
Placebo Comparator: A group (control group)
diet with low content of omega-3 fatty acids and polyphenols
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154478

Locations
Italy
Federico II University
Napoli, Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Study Director: Giovanni Annuzzi Federico II University
  More Information

No publications provided

Responsible Party: rivellese angela, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT01154478     History of Changes
Other Study ID Numbers: EpWP5
Study First Received: June 14, 2010
Last Updated: June 18, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
polyphenols omega-3 postprandial lipemia adipose tissue

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014