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The Heart Institute of Spokane Diet Study

The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00269425
Enrollment
202
Registered
2005-12-23
Start date
2000-10-31
Completion date
2008-01-31
Last updated
2010-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Cardiovascular disease, Nutrition, Mediterranean diet, Low fat diet, American Heart Association diet, Monounsaturated fats, Omega-3 fats, Outcomes

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.

Interventions

BEHAVIORALAmerican Heart Association Step 2 diet

Low fat diet with patient education and diet analysis

BEHAVIORALMediterranean diet

Mediterranean style diet with patient education and diet analysis

Sponsors

The Heart Institute of Spokane
CollaboratorUNKNOWN
Providence Medical Research Center
CollaboratorOTHER
Washington State Attorney General's Office
CollaboratorOTHER
Deaconess Medical Center, Spokane, Washington
CollaboratorOTHER
Providence Health & Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fatal/non-fatal myocardial infarction3,6,12,18,24,36,48,60,72 monthsThe primary outcome was a composite of end points including all-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina, or stroke.
Cardiovascular death3,6,12,18,24,36,48,60,72 months
Non-cardiovascular death3,6,12,18,24,36,48,60,72 months
Stroke/TIA3,6,12,18,24,36,48,60,72 months
Admission for congestive heart failure or unstable angina3,6,12,18,24,36,48,60,72 months

Secondary

MeasureTime frame
Cardiovascular revascularization3,6,12,18,24,36,48,60,72 months
Risk factors (traditional and novel)3,6,12,18,24,36,48,60,72 months
Peripheral revascularization or amputation3,6,12,18,24,36,48,60,72 months
Doubling of serum creatinine,dialysis,or kidney transplant3,6,12,18,24,36,48,60,72 months
New hypertension3,6,12,18,24,36,48,60,72 months
New diabetes3,6,12,18,24,36,48,60,72 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026