Study [ETHERPATHS] study / subjects / design / samples / assays

Basic properties of your study This page shows the basic information about your study, as well as information on the authorizations.

Publications

  • Diets naturally rich in polyphenols improve fasting and postprandial dyslipidemia and reduce oxidative stress: a randomized controlled trial.
    Annuzzi G, Bozzetto L, Costabile G, Giacco R, Mangione A, Anniballi G, Vitale M, Vetrani C, Cipriano P, Della Corte G, Pasanisi F, Riccardi G, Rivellese AA
  • Isoenergetic diets differing in their n-3 fatty acid and polyphenol content reflect different plasma and HDL-fraction lipidomic profiles in subjects at high cardiovascular risk.
    Bondia-Pons I, Pöhö P, Bozzetto L, Vetrani C, Patti L, Aura AM, Annuzzi G, Hyötyläinen T, Rivellese AA, Orešič M
  • Test meals rich in marine long-chain n-3 polyunsaturated fatty acids increase postprandial chylomicron response.
    Griffo E, Di Marino L, Patti L, Bozzetto L, Annuzzi G, Cipriano P, Mangione A, Della Pepa G, Cocozza S, Riccardi G, Rivellese AA
  • Metabolic transformations of dietary polyphenols: comparison between in vitro colonic and hepatic models and in vivo urinary metabolites.
    Vetrani C, Rivellese AA, Annuzzi G, Adiels M, Borén J, Mattila I, Orešič M, Aura AM
  • Polyphenol-rich diets improve glucose metabolism in people at high cardiometabolic risk: a controlled randomised intervention trial.
    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

Contacts

  • Tullin, Mikkel
    Data Submission

Authorization

Public Design
Yes
Readers
zefoteus
mariona.pinart
Mikkel.Tullin
rosalba.giacco
ENPADASI
Writers
zefoteus
mariona.pinart
Mikkel.Tullin
rosalba.giacco
ENPADASI
Study 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
Template
Intervention/Observation study
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
description
Focusing on Postprandial Lipids Metabolism
code
ETHERPATHS
startDate
2010-01-01 00:00:00.0
Study type
Human Intervention
Principle Investigator
Angela Albarosa Rivellese
Primary endpoint
Postprandial lipids metabolism
Objectives
The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids, may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk.
Central conclusion
After 8 weeks polyphenol-rich diet, : 1) reduced plasma levels of triglycerides and VLDL large in the fasting and the postprandial state ;2) reduced urinary excretion of 8- isoprostane (a marker of oxidative stress); 3) after OGTT, reduced the glycemic response, increased the early response of insulin secretion and improved insulin sensitivity.
Main health-related outcome
Metabolic syndrome
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
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
Institute
Federico II University of Naples
Clinicaltrials.gov or similar number
NCT01154478
Did the individuals providing data sign informed consent?
Yes
Study design
Parallel
Description of "Start groups"
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.
Control group
Yes
Type of controls
Control diet poor in omega-3 fatty acids and polyphenols
Randomisation
Yes
Full randomisation method (if any)
Computer random number generator
Blinding (yes/no)
No
Study terminated?
Yes
Compliance assessed?
Yes
Compliance assessment (for each treatment)
7-day food records
Factorial design?
Yes
Number of factors (for factorial designs only)
2
Total number of arms (Give number of distinct treatments in study)
4
Explanatory text (Give a textual account of the overall design leading to the total number of groups) or provide the study protocol.
According to a 2 × 2 factorial design, 86 overweight/obese individuals with a large waist circumference and any other component of the metabolic syndrome were randomly assigned to an isoenergetic diet 1) poor in LCn3s and polyphenols, 2) rich in LCn3s, 3) rich in polyphenols, or 4) rich in LCn3s and polyphenols. The diets were similar in all other components. Before and after the 8-wk intervention, fasting and postmeal TRLs and 8-isoprostane concentrations in 24-h urine samples were measured.
Treatments (Number and types of foods, drugs or other treatments compared)
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
Number of volunteers screened N(M:xx, F: xx)
268 volunteers assessed for elegibility
Number of volunteers enrolled N(M:xx, F: xx)
86 volunteers randomized
Number of subjects (Male; Female)
Seventy-eight participants completed the study (M: 33; F: 45)
Start of recruitment (Start year or date)
2010-01-01 00:00:00.0
End of recruitment (End year or date)
2012-12-31 00:00:00.0
Follow-up planned
No
Follow-up
No

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