Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01154478
Acronym
Etherpaths
Enrollment
86
Registered
2010-07-01
Start date
2010-01-31
Completion date
2012-06-30
Last updated
2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

polyphenols omega-3 postprandial lipemia adipose tissue

Brief 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

Interventions

fish at least 3 times per week, large leaf vegetables

OTHERDiet rich in polyphenols

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

OTHERControl 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)

OTHERdiet 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

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction48 months

Secondary

MeasureTime frame
insulin sensitivity48 months
plasma and adipose tissue adipokines48 months
endothelial function48 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026