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
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
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.
Type of controls
Control diet poor in omega-3 fatty acids and polyphenols
Full randomisation method (if any)
Computer random number generator
Compliance assessment (for each treatment)
7-day food records
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
