Clinical Trials Directory

Trials / Completed

CompletedNCT01154478

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
86 (actual)
Sponsor
Federico II University · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
OTHERDiet rich in omega-3 fatty acidsfish at least 3 times per week, large leaf vegetables
OTHERDiet rich in polyphenolsextra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
OTHERControl dietlow 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)
OTHERdiet rich in omega-3 and polyphenolsFish at least 3 times x week,large leaf vegetables + extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee

Timeline

Start date
2010-01-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2010-07-01
Last updated
2013-06-19

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01154478. Inclusion in this directory is not an endorsement.