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Completed

NCT Number: NCT00269425

The Heart Institute of Spokane Diet Study

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Providence Medical Research Center

Spokane, Washington, 99204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

American Heart Association Step 2 diet

Behavioral

Low fat diet with patient education and diet analysis

Other names: Low fat diet

Mediterranean Diet

Behavioral

Mediterranean style diet with patient education and diet analysis

Primary outcomes

  1. Fatal/non-fatal myocardial infarction

    Time frame: 3,6,12,18,24,36,48,60,72 months

    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.

  2. Cardiovascular death

    Time frame: 3,6,12,18,24,36,48,60,72 months

  3. Non-cardiovascular death

    Time frame: 3,6,12,18,24,36,48,60,72 months

  4. Stroke/TIA

    Time frame: 3,6,12,18,24,36,48,60,72 months

  5. Admission for congestive heart failure or unstable angina

    Time frame: 3,6,12,18,24,36,48,60,72 months

Secondary outcomes

  1. Cardiovascular revascularization

    Time frame: 3,6,12,18,24,36,48,60,72 months

  2. Peripheral revascularization or amputation

    Time frame: 3,6,12,18,24,36,48,60,72 months

  3. Doubling of serum creatinine,dialysis,or kidney transplant

    Time frame: 3,6,12,18,24,36,48,60,72 months

  4. New hypertension

    Time frame: 3,6,12,18,24,36,48,60,72 months

  5. New diabetes

    Time frame: 3,6,12,18,24,36,48,60,72 months

  6. Risk factors (traditional and novel)

    Time frame: 3,6,12,18,24,36,48,60,72 months

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Collaborators

  • Deaconess Medical Center, Spokane, Washington
  • Providence Medical Research Center
  • The Heart Institute of Spokane
  • Washington State Attorney General's Office

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Dec 23, 2005
Registry last updated
Aug 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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