An Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile

NCT ID: NCT02578329

Last Updated: 2016-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-02-28

Brief Summary

The purpose of this study is to determine whether a Mediterranean Diet, personalized in terms of total calories, total lipids and balanced in terms of saturated, mono- and poly-unsaturated lipids, corrects the adverse fatty acid profile of patients with CHD and reduces markers of oxidative stress and inflammation more effectively than a low-fat dietary advice.

Detailed Description

Geographical differences in the incidence of CardioVascular Disease (CVD) show a lower risk in countries of south Europe compared with north and east Europe and USA. The Mediterranean Diet (MD) has been the most frequently invoked factor to explain these differences, but the underlying mechanisms are still unclear. On the other hand, blood fatty acid (FA) composition has been shown to be strongly related to cardiovascular risk, presumably through changes in oxidative stress and inflammatory pathways, two mechanisms involved in the pathogenesis of atherothrombosis. Preliminary data from our group suggest that patients with Coronary Heart Disease (CHD) adhere less to features of MD and exhibit a different fatty acid profile compared to healthy subjects. We speculate that MD may reduce oxidative stress and inflammatory markers, and reverse the unfavorable blood fatty acid profile observed in patients with CHD. Even though single MD components (wine, olive oil, vegetables, fish, etc) have shown beneficial effects on oxidative stress, inflammation and CardioVascular (CV) risk, evidence indicates that these effects are mostly related to the extent of compliance with the whole MD, which comprises possible synergism between food components. For this reason, the present study will consider the whole MD and not single components.

Design: randomized, parallel groups, open-label, intervention trial. Intervention: an intensively advised MD (fatty fish at least 3 times/week; legumes 2-3 times/ week; vegetables twice a day; fruits twice/day; 30-45g olive oil/day; 1-2 glasses of red wine/day, not more than 150g red meat/week), personalized in terms of calories, total lipids and balanced in terms of saturated, mono- and poly-unsaturated lipids (n= 75) vs. usual low-fat dietary advice (n=75) for 3 months. Participants: males and females, age 30-75, with a recent history of coronary revascularization, randomized after clinical stabilization (at least 60 days after any coronary procedure or event).

At baseline and after intervention in both groups:

Dietary assessment: using the EPIC questionnaire, a well validated dietary recall tool.

Blood, urinary and fecal samples: routine biochemical determinations, blood fatty acid composition by gas-chromatography, C reactive protein and oxidative stress markers (urinary isoprostanes, whole blood reduced and oxidized glutathione by Liquid Chromatography- Mass Spectrometry (LC-MS/MS), plasma alpha- and gamma-tocopherol by High Performance Liquid Chromatography (HPLC) with fluorimetric detector), gene expression and/or epigenome in peripheral whole blood cells (as an index of global changes of inflammation/immune response), intestinal microbiome.

Statistical analysis: Principal component analysis to characterize fatty acid patterns. Score of Trichopoulou to assess adherence to MD.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Med Diet

Intensively advised Mediterranean diet

Group Type: EXPERIMENTAL

Intensively advised Mediterranean diet

Intervention Type: BEHAVIORAL

Mediterranean Diet: fatty fish 3 times/week; legumes 2-3 times/week; vegetables twice/day; fresh fruits twice/day; 30 to 45g olive oil/day; 1-2 glasses red wine/day; less than 150g red meat/week

Low Fat diet

usual low-fat dietary advice

Group Type: ACTIVE_COMPARATOR

usual low-fat dietary advice

Intervention Type: BEHAVIORAL

usual low-fat dietary advice for cardiovascular disease

Interventions

Intensively advised Mediterranean diet

Mediterranean Diet: fatty fish 3 times/week; legumes 2-3 times/week; vegetables twice/day; fresh fruits twice/day; 30 to 45g olive oil/day; 1-2 glasses red wine/day; less than 150g red meat/week

Intervention Type: BEHAVIORAL

usual low-fat dietary advice

usual low-fat dietary advice for cardiovascular disease

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of coronary artery disease
• recent history of a first coronary revascularization
• at least 60 days after any coronary procedure or event
• age between 30 and 75 years

Exclusion Criteria

• diagnosis of diabetes mellitus
• food intolerance to any component of the mediterranean diet
• BMI < 19 or > 33
• assuming drugs or food supplements with omega-3 fatty acids or natural or synthetic antioxidants.
• patients already adherent to a full mediterranean diet

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Fabrizio Veglia

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Cardiologico Monzino, IRCCS

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabrizio Veglia, PhD

Role: CONTACT

fabrizio.veglia@ccfm.it

+39 025800 ext. 2827

Monica G Giroli, PhD

Role: CONTACT

monica.giroli@ccfm.it

+39 02 5800 ext. 2617

Facility Contacts

Fabrizio Veglia, PhD

Role: primary

fabrizio.veglia@ccfm.it

+39 02 5800 ext. 2827

Monica G Giroli, PhD

Role: backup

monica.giroli@ccfm.it

+39 02 5800 ext. 2617

Other Identifiers

R194/14 - CCM203

Identifier Type: -

Identifier Source: org_study_id