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

NCT01154478 | Completed

• 1 other identifier: EpWP5
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

polyphenols omega-3 postprandial lipemia adipose tissue

Outcome Measures

Primary Outcomes (1)

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

  48 months

Secondary Outcomes (3)

• insulin sensitivity

  48 months

• plasma and adipose tissue adipokines

  48 months

• endothelial function

  48 months

Study Arms (4)

B group

EXPERIMENTAL

Diet rich in omega-3 fatty acids

Other: Diet rich in omega-3 fatty acids

C group

EXPERIMENTAL

Diet rich in polyphenols

Other: Diet rich in polyphenols

D group

EXPERIMENTAL

Diet rich in polyphenols and in omega-3 fatty acids

Other: diet rich in omega-3 and polyphenols

A group (control group)

PLACEBO COMPARATOR

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

Other: Control diet

Interventions

Diet rich in omega-3 fatty acids OTHER

fish at least 3 times per week, large leaf vegetables

B group

Diet rich in polyphenols OTHER

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

C group

Control diet OTHER

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)

A group (control group)

diet rich in omega-3 and polyphenols OTHER

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

D group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Napoli, Naples, 80131, Italy

Location

Related Publications (4)

• 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.

  PMID: 34091663 DERIVED

• 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.

  PMID: 31249395 DERIVED

• 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.

  PMID: 27134062 DERIVED

• 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.

  PMID: 25906754 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Fatty Acids, Omega-3; Polyphenols; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Giovanni Annuzzi

  Federico II University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: July 1, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

IT (1)