Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269425
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2005-12-22
Brief Title:
The Heart Institute of Spokane Diet Study
Sponsor:
Providence Health Services
Organization:
Providence Health Services
Study Overview
Official Title:
The Heart Institute of Spokane Diet Intervention and Evaluation Trial THIS DIET
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgd 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
Comparisons 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
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 mgd 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
Comparisons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None