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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diet rich in omega-3 fatty acids
Diet rich in polyphenols
Control diet
diet rich in omega-3 and polyphenols
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring polyphenols omega-3 postprandial lipemia adipose tissue

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federico II University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

B group

C group

D group

A group (control group)

Arm Description

Diet rich in omega-3 fatty acids

Diet rich in polyphenols

Diet rich in polyphenols and in omega-3 fatty acids

diet with low content of omega-3 fatty acids and polyphenols

Outcomes

Primary Outcome Measures

incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction

Secondary Outcome Measures

insulin sensitivity
plasma and adipose tissue adipokines
endothelial function

Full Information

First Posted
June 14, 2010
Last Updated
June 18, 2013
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT01154478
Brief Title
Effects of Dietary Polyphenols and ω-3 Fatty Acids on Cardiovascular Risk Factors in High Risk Subjects
Acronym
Etherpaths
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
polyphenols omega-3 postprandial lipemia adipose tissue

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B group
Arm Type
Experimental
Arm Description
Diet rich in omega-3 fatty acids
Arm Title
C group
Arm Type
Experimental
Arm Description
Diet rich in polyphenols
Arm Title
D group
Arm Type
Experimental
Arm Description
Diet rich in polyphenols and in omega-3 fatty acids
Arm Title
A group (control group)
Arm Type
Placebo Comparator
Arm Description
diet with low content of omega-3 fatty acids and polyphenols
Intervention Type
Other
Intervention Name(s)
Diet rich in omega-3 fatty acids
Intervention Description
fish at least 3 times per week, large leaf vegetables
Intervention Type
Other
Intervention Name(s)
Diet rich in polyphenols
Intervention Description
extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
diet rich in omega-3 and polyphenols
Intervention Description
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
Primary Outcome Measure Information:
Title
incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction
Time Frame
48 months
Secondary Outcome Measure Information:
Title
insulin sensitivity
Time Frame
48 months
Title
plasma and adipose tissue adipokines
Time Frame
48 months
Title
endothelial function
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Annuzzi
Organizational Affiliation
Federico II University
Official's Role
Study Director
Facility Information:
Facility Name
Federico II University
City
Napoli
State/Province
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
34091663
Citation
Costabile G, Vetrani C, Bozzetto L, Giacco R, Bresciani L, Del Rio D, Vitale M, Della Pepa G, Brighenti F, Riccardi G, Rivellese AA, Annuzzi G. Plasma TMAO increase after healthy diets: results from 2 randomized controlled trials with dietary fish, polyphenols, and whole-grain cereals. Am J Clin Nutr. 2021 Oct 4;114(4):1342-1350. doi: 10.1093/ajcn/nqab188.
Results Reference
derived
PubMed Identifier
31249395
Citation
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.
Results Reference
derived
PubMed Identifier
27134062
Citation
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.
Results Reference
derived
PubMed Identifier
25906754
Citation
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.
Results Reference
derived

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

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