The Heart Institute of Spokane Diet Study

This study has been completed.
Sponsor:
Collaborators:
The Heart Institute of Spokane
Providence Medical Research Center
Washington State Attorney General’s Office
Deaconess Medical Center, Spokane, Washington
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00269425
First received: December 22, 2005
Last updated: August 23, 2010
Last verified: December 2005
  Purpose

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).


Condition Intervention Phase
Myocardial Infarction
Behavioral: American Heart Association Step 2 diet
Behavioral: Mediterranean diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Fatal/non-fatal myocardial infarction [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
    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.

  • Cardiovascular death [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Non-cardiovascular death [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Stroke/TIA [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Admission for congestive heart failure or unstable angina [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular revascularization [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Peripheral revascularization or amputation [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Doubling of serum creatinine,dialysis,or kidney transplant [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • New hypertension [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • New diabetes [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]
  • Risk factors (traditional and novel) [ Time Frame: 3,6,12,18,24,36,48,60,72 months ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: October 2000
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mediterranean diet, Behavioral: Mediterranean diet
Mediterranean style diet with patient education and diet analysis
Other Name: Mediterranean diet
Experimental: American Heart Association Step 2 diet Behavioral: American Heart Association Step 2 diet
Low fat diet with patient education and diet analysis
Other Name: Low fat diet
No Intervention: Case controlled

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269425

Locations
United States, Washington
Providence Medical Research Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Providence Health & Services
The Heart Institute of Spokane
Providence Medical Research Center
Washington State Attorney General’s Office
Deaconess Medical Center, Spokane, Washington
Investigators
Principal Investigator: Katherine R. Tuttle, MD,FASN,FACP Providence Medical Research Center
  More Information

No publications provided

Responsible Party: Katherine R. Tuttle, MD, Providence Medical Research Center
ClinicalTrials.gov Identifier: NCT00269425     History of Changes
Other Study ID Numbers: THIS-A20010724157261
Study First Received: December 22, 2005
Last Updated: August 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Providence Health & Services:
Cardiovascular disease
Nutrition
Mediterranean diet
Low fat diet
American Heart Association diet
Monounsaturated fats
Omega-3 fats
Outcomes

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014