Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2000-10-31
2008-01-31
Brief Summary
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Detailed Description
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Excess dietary fat has long been associated with cardiovascular diseases. Increased risk is related both to types of fat and calories from fat. Saturated fat, cholesterol, and trans-fatty acids have all been associated with adverse outcomes. Because fat is calorie-laden, high fat diets are commonly associated with weight gain and obesity. Low-fat diets have traditionally been recommended to control lipids and weight. However, these diets are high in carbohydrate and may actually be associated with weight gain if calories are not limited. Such diets have also been associated with worsening of hyperinsulinemia and insulin resistance and an adverse lipid pattern (low HDL cholesterol and high triglyceride levels). In contrast, increased intake of monounsaturated and omega-3 fats is associated with favorable effects on cardiovascular risk factors and markers including: endothelial function, lipids, and levels of insulin and glucose. Results have been consistent across various groups of high-risk patients, including those with hypercholesterolemia, diabetes, and hypertension. Most importantly, a Mediterranean style diet enriched in monounsaturated and omega-3 fats reduced death and cardiovascular complications after myocardial infarction (MI) in the Lyon Heart study.
The American Heart Association (AHA) Step 2 is a low-fat diet traditionally recommended for people with cardiovascular disease. The Mediterranean and AHA Step 2 diets differ primarily in the amount of monounsaturated and omega-3 fats, both of which are higher in the Mediterranean diet. Both diets are low in saturated fat (less than 7%) and cholesterol (less than 200 mg/d). Although the Lyon Heart Study compared a Mediterranean diet to a "prudent Western diet," a low fat diet similar to the AHA diet, the latter group did not achieve recommended intake levels of saturated fat or cholesterol. Furthermore, there was no longitudinal nutritional intervention in the low fat diet group. Therefore, the effect of nutritional intervention per se was not addressed.
Comparison(s): In survivors of a first MI, two longitudinal nutritional interventions, a Mediterranean style diet and an AHA Step 2 diet, will be compared. Both intervention groups will be compared to an untreated control group from our clinical database.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mediterranean diet,
Mediterranean diet
Mediterranean style diet with patient education and diet analysis
American Heart Association Step 2 diet
American Heart Association Step 2 diet
Low fat diet with patient education and diet analysis
Case controlled
No interventions assigned to this group
Interventions
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American Heart Association Step 2 diet
Low fat diet with patient education and diet analysis
Mediterranean diet
Mediterranean style diet with patient education and diet analysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Uncontrolled or secondary hypertension
* New York Heart Association heart failure stage III or IV
* Ventricular arrythmias requiring medical or defibrillatory intervention
* Other diseases that may make study completion difficult or unlikely
18 Years
ALL
No
Sponsors
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The Heart Institute of Spokane
UNKNOWN
Providence Medical Research Center
OTHER
Washington State Attorney General's Office
OTHER
Deaconess Medical Center, Spokane, Washington
OTHER
Providence Health & Services
OTHER
Responsible Party
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Providence Medical Research Center
Principal Investigators
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Katherine R. Tuttle, MD,FASN,FACP
Role: PRINCIPAL_INVESTIGATOR
Providence Medical Research Center
Locations
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Providence Medical Research Center
Spokane, Washington, United States
Countries
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Other Identifiers
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THIS-A20010724157261
Identifier Type: -
Identifier Source: org_study_id
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