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CompletedNCT00269425Updated Aug 24, 2010

The Heart Institute of Spokane Diet Study

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

Phase
Phase 3
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • Cardiovascular disease
  • Nutrition
  • Mediterranean diet
  • Low fat diet
  • American Heart Association diet
  • Monounsaturated fats
  • Omega-3 fats
  • Outcomes
03

In context

Myocardial Infarction

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • First myocardial infarction

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
202 participants (actual)

Study arms

  • Experimental
    Mediterranean diet,

    Behavioral: Mediterranean diet

  • Experimental
    American Heart Association Step 2 diet

    Behavioral: American Heart Association Step 2 diet

  • No intervention
    Case controlled

Interventions

  • BehavioralAmerican Heart Association Step 2 diet

    Low fat diet with patient education and diet analysis

    Also known as: Low fat diet

  • BehavioralMediterranean diet

    Mediterranean style diet with patient education and diet analysis

06

What researchers measure

Primary outcomes

  1. 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

  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

07

Study locations

1 site
  • Providence Medical Research Center
    Spokane, Washington 99204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00269425
Lead sponsor
Providence Health & Services
Collaborators
The Heart Institute of Spokane, Providence Medical Research Center, Washington State Attorney General's Office, Deaconess Medical Center, Spokane, Washington
First posted
Dec 23, 2005
Start date
Oct 2000
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Aug 24, 2010

Study contacts

Katherine R. Tuttle, MD,FASN,FACP
principal investigator · Providence Medical Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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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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