Cardiovascular Outcomes Of Diet Counseling

Sponsor

The Camelot Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00324545

Collaborator

GM Harrington, PhD (Other)

120

Enrollment

Locations

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Obesity	Behavioral: Medium-intensity Minimally-directive Counseling	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets

Actual Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Dec 31, 2002

Study Completion Date :

Dec 31, 2002

Outcome Measures

Primary Outcome Measures

coronary blood flow []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria: BMI greater than 30,

Exclusion criteria: pre-existing co-morbid diseases (documented heart disease, diabetes mellitus, cancer, hypertension, hepatic, renal or gastrointestinal disease), pregnancy or plans for pregnancy. Participants could not be smokers (cigarettes, cigars, pipes or chewing tobacco), take medications (prescription or over the counter medications with the exception of antibiotics), nor take vitamin or mineral supplements. Additionally, they could not currently be on a diet or have been on one during the last 6 months, or have food allergies that would influence food choices.