The Heart Institute of Spokane Diet Study
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|ClinicalTrials.gov Identifier: NCT00269425|
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : August 24, 2010
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Behavioral: American Heart Association Step 2 diet Behavioral: Mediterranean diet||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Heart Institute of Spokane Diet Intervention and Evaluation Trial (THIS DIET)|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
|Experimental: Mediterranean diet,||
Behavioral: Mediterranean diet
Mediterranean style diet with patient education and diet analysis
|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|
- 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.
- Cardiovascular death [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- Non-cardiovascular death [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- Stroke/TIA [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- Admission for congestive heart failure or unstable angina [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- Cardiovascular revascularization [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- Peripheral revascularization or amputation [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- Doubling of serum creatinine,dialysis,or kidney transplant [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- New hypertension [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- New diabetes [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
- Risk factors (traditional and novel) [ Time Frame: 3,6,12,18,24,36,48,60,72 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269425
|United States, Washington|
|Providence Medical Research Center|
|Spokane, Washington, United States, 99204|
|Principal Investigator:||Katherine R. Tuttle, MD,FASN,FACP||Providence Medical Research Center|