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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Diet rich in omega-3 fatty acids; Other: Diet rich in polyphenols; Other: diet rich in omega-3 and polyphenols; Other: Control diet

• Registration Number: NCT01154478
• Lead Sponsor: Federico II University

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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B group	Diet rich in omega-3 fatty acids	Diet rich in omega-3 fatty acids
C group	Diet rich in polyphenols	Diet rich in polyphenols
D group	diet rich in omega-3 and polyphenols	Diet rich in polyphenols and in omega-3 fatty acids
A group (control group)	Control diet	diet with low content of omega-3 fatty acids and polyphenols

Primary Outcome Measures

Name	Time	Method
incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction	48 months

Secondary Outcome Measures

Name	Time	Method
insulin sensitivity	48 months
endothelial function	48 months
plasma and adipose tissue adipokines	48 months

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Napoli, Naples, Italy