An Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile
RISMED
A Randomized Intervention Study to Assess the Effect of the Mediterranean Diet on the Plasma Fatty Acid Profile
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
October 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJune 7, 2016
June 1, 2016
2.3 years
July 23, 2015
June 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of whole blood fatty acid profile
Urinary isoprostanes (8-iso-PGF2-alpha will be measured at randomization and after dietary intervention by liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods.
three months
Secondary Outcomes (7)
Effect of Mediterranean diet on urinary isoprostanes
three months
Effect of Mediterranean diet on oxidized glutathione
three months
Effect of Mediterranean diet on reduced glutathione
three months
Effect of Mediterranean diet on plasma Vitamin E
three months
Effect of Mediterranean diet on Low-grade systemic inflammatory status
three months
- +2 more secondary outcomes
Study Arms (2)
Med Diet
EXPERIMENTALIntensively advised Mediterranean diet
Low Fat diet
ACTIVE COMPARATORusual low-fat dietary advice
Interventions
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
usual low-fat dietary advice for cardiovascular disease
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Cardiologico Monzino, IRCCS
Milan, MI, 20138, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 23, 2015
First Posted
October 16, 2015
Study Start
July 1, 2015
Primary Completion
October 1, 2017
Study Completion
February 1, 2018
Last Updated
June 7, 2016
Record last verified: 2016-06