Clinical trial NCT02578329: An Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile
Official title: A Randomized Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Mediterranean diet
blood fatty acid
Coronary Artery Disease
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of whole blood fatty acid profile
timeFrame: three months
Secondary outcomes:
measure: Effect of Mediterranean diet on urinary isoprostanes
timeFrame: three months
measure: Effect of Mediterranean diet on oxidized glutathione
timeFrame: three months
measure: Effect of Mediterranean diet on reduced glutathione
timeFrame: three months
measure: Effect of Mediterranean diet on plasma Vitamin E
timeFrame: three months
measure: Effect of Mediterranean diet on Low-grade systemic inflammatory status
timeFrame: three months
measure: Effect of Mediterranean diet on peripheral blood transcriptome
timeFrame: three months
measure: Significant differences in the relative abundance of the operational taxonomic units (OTU) within subjects
timeFrame: three months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino, IRCCS
state: MI
Study officials:
References: