Cardiovascular Outcomes Of Diet Counseling

Phase 3

Completed

• Conditions: Coronary Artery Disease; Obesity

• Registration Number: NCT00324545
• Lead Sponsor: The Camelot Foundation

Brief Summary

(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Detailed Description

Given the current epidemic of overweight and obesity on a global scale ("globesity") and the consequent world public health objective of reducing that obesity, it is evident as a practical matter that, the main line of attack must be through diet. The public health objective and the lack of information regarding the long-term public health effects of alternative weight-loss diets motivated this comparative study of the three major types of weight-loss diets and their long term effects on coronary blood flow. Secondary endpoints are inflammatory and other variables associated with heart disease and obesity.

Specifically we asked: (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2002-12-31
• Study Completion: 2002-12-31
• Study First Submitted: 2006-05-09
• Study First Submitted QC: 2006-05-09
• Study First Posted: 2006-05-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
coronary blood flow

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol
HDLc
VLDLc
BMI
weight
Fibrinogen
LDLc
Triglycerides
TG/HDL (Insulin Resistance)
CRP
Homocysteine
Lipoprotein (a)
respiratory quotient
TC/HDL
IL-6

Trial Locations

Locations (2)

Keith Block; 🇺🇸 Chicago, Illinois, United States

Richard M. Fleming, MD; 🇺🇸 Omaha, Nebraska, United States