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

• ClinicalTrials.gov Identifier: NCT01154478
• Recruitment Status: Completed
• First Posted: July 1, 2010
• Last Update Posted: June 19, 2013
• Sponsor: Federico II University
• Information provided by (Responsible Party): rivellese angela, Federico II University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: January 2010
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction [ Time Frame: 48 months ]

Secondary Outcome Measures :

1. insulin sensitivity [ Time Frame: 48 months ]
2. plasma and adipose tissue adipokines [ Time Frame: 48 months ]
3. endothelial function [ Time Frame: 48 months ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Della Pepa G, Vetrani C, Vitale M, Bozzetto L, Costabile G, Cipriano P, Mangione A, Patti L, Riccardi G, Rivellese AA, Annuzzi G. Effects of a diet naturally rich in polyphenols on lipid composition of postprandial lipoproteins in high cardiometabolic risk individuals: an ancillary analysis of a randomized controlled trial. Eur J Clin Nutr. 2020 Jan;74(1):183-192. doi: 10.1038/s41430-019-0459-0. Epub 2019 Jun 27.

Bozzetto L, Annuzzi G, Ragucci M, Di Donato O, Della Pepa G, Della Corte G, Griffo E, Anniballi G, Giacco A, Mancini M, Rivellese AA. Insulin resistance, postprandial GLP-1 and adaptive immunity are the main predictors of NAFLD in a homogeneous population at high cardiovascular risk. Nutr Metab Cardiovasc Dis. 2016 Jul;26(7):623-629. doi: 10.1016/j.numecd.2016.01.011. Epub 2016 Apr 14.

Bozzetto L, Annuzzi G, Pacini G, Costabile G, Vetrani C, Vitale M, Griffo E, Giacco A, De Natale C, Cocozza S, Della Pepa G, Tura A, Riccardi G, Rivellese AA. Polyphenol-rich diets improve glucose metabolism in people at high cardiometabolic risk: a controlled randomised intervention trial. Diabetologia. 2015 Jul;58(7):1551-60. doi: 10.1007/s00125-015-3592-x. Epub 2015 Apr 24.

• Responsible Party: rivellese angela, Associate Professor, Federico II University
• ClinicalTrials.gov Identifier: NCT01154478
• Other Study ID Numbers: EpWP5
• First Posted: July 1, 2010
• Last Update Posted: June 19, 2013
• Last Verified: June 2013

Keywords provided by rivellese angela, Federico II University:

polyphenols omega-3 postprandial lipemia adipose tissue

Additional relevant MeSH terms:

Metabolic Syndrome; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases