A Phase 3 interventional study of American Heart Association Step 2 diet and Mediterranean diet in Myocardial Infarction, sponsored by Providence Health & Services. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-24.
Sponsored by Providence Health & Services · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether a Mediterranean style diet, enriched in monounsaturated and omega-3 fats, is superior to the American Heart Association Step 2 diet, a traditional low fat diet, for improving rates of survival and cardiovascular complications in persons who have had a first myocardial infarction (heart attack).
Cardiovascular diseases (heart attack, stroke, and other vascular diseases) are major causes of mortality in developed countries. Although medicines and revascularization procedures prolong lives, rates of death and disability remain high. Lifestyle factors greatly contribute to risk. Yet, scientific data regarding the role of lifestyle change in prevention and treatment are limited. In the nutrition area, limitations include observational or uncontrolled study design, and focus on surrogate markers rather than on clinical outcomes.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 202 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Providence Health & Services is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Mediterranean diet
Behavioral: American Heart Association Step 2 diet
Low fat diet with patient education and diet analysis
Also known as: Low fat diet
Mediterranean style diet with patient education and diet analysis
Fatal/non-fatal myocardial infarction
The primary outcome was a composite of end points including all-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina, or stroke.
Time frame: 3,6,12,18,24,36,48,60,72 months
Cardiovascular death
Time frame: 3,6,12,18,24,36,48,60,72 months
Non-cardiovascular death
Time frame: 3,6,12,18,24,36,48,60,72 months
Stroke/TIA
Time frame: 3,6,12,18,24,36,48,60,72 months
Admission for congestive heart failure or unstable angina
Time frame: 3,6,12,18,24,36,48,60,72 months
Cardiovascular revascularization
Time frame: 3,6,12,18,24,36,48,60,72 months
Peripheral revascularization or amputation
Time frame: 3,6,12,18,24,36,48,60,72 months
Doubling of serum creatinine,dialysis,or kidney transplant
Time frame: 3,6,12,18,24,36,48,60,72 months
New hypertension
Time frame: 3,6,12,18,24,36,48,60,72 months
New diabetes
Time frame: 3,6,12,18,24,36,48,60,72 months
Risk factors (traditional and novel)
Time frame: 3,6,12,18,24,36,48,60,72 months
This study is completed, as verified in Dec 2005. You cannot join it, but the record below documents what was studied.
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