Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01154478
Other study ID # EpWP5
Secondary ID
Status Completed
Phase N/A
First received June 14, 2010
Last updated June 18, 2013
Start date January 2010
Est. completion date June 2012

Study information

Verified date June 2013
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Diet rich in omega-3 fatty acids
fish at least 3 times per week, large leaf vegetables
Diet rich in polyphenols
extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
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)
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

Locations

Country Name City State
Italy Federico II University Napoli Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction 48 months No
Secondary insulin sensitivity 48 months No
Secondary plasma and adipose tissue adipokines 48 months No
Secondary endothelial function 48 months No
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A