Clinical trial NCT00269425: The Heart Institute of Spokane Diet Study
Official title: The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Cardiovascular disease
Nutrition
Mediterranean diet
Low fat diet
American Heart Association diet
Monounsaturated fats
Omega-3 fats
Outcomes
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: The Heart Institute of Spokane
name: Providence Medical Research Center
name: Washington State Attorney General's Office
name: Deaconess Medical Center, Spokane, Washington
First posted: 2005-12-23
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* First myocardial infarction

Exclusion Criteria:

* Prior myocardial infarction
* 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

Primary outcomes:
measure: Fatal/non-fatal myocardial infarction
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: Cardiovascular death
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: Non-cardiovascular death
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: Stroke/TIA
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: Admission for congestive heart failure or unstable angina
timeFrame: 3,6,12,18,24,36,48,60,72 months
Secondary outcomes:
measure: Cardiovascular revascularization
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: Peripheral revascularization or amputation
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: Doubling of serum creatinine,dialysis,or kidney transplant
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: New hypertension
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: New diabetes
timeFrame: 3,6,12,18,24,36,48,60,72 months
measure: Risk factors (traditional and novel)
timeFrame: 3,6,12,18,24,36,48,60,72 months
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Providence Medical Research Center
state: Washington
Study officials:
affiliation: Providence Medical Research Center
name: Katherine R. Tuttle, MD,FASN,FACP
role: PRINCIPAL_INVESTIGATOR
References: