Clinical trial NCT00324545: Cardiovascular Outcomes Of Diet Counseling
Official title: Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Obesity
Keywords: Obesity
Diets
Heart Disease
Randomized controlled trial
Ischemia.
Lead sponsor: The Camelot Foundation
Sponsor class: OTHER
Collaborators: name: GM Harrington, PhD
First posted: 2006-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Eligibility criteria: 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.

Primary outcomes:
measure: coronary blood flow
Secondary outcomes:
measure: weight
measure: BMI
measure: LDLc
measure: Total Cholesterol
measure: HDLc
measure: Triglycerides
measure: Homocysteine
measure: Fibrinogen
measure: Lipoprotein (a)
measure: VLDLc
measure: TC/HDL
measure: TG/HDL (Insulin Resistance)
measure: CRP
measure: IL-6
measure: respiratory quotient
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Keith Block
state: Illinois
city: Omaha
country: United States
facility: Richard M. Fleming, MD
state: Nebraska
Study officials:
affiliation: Camelot Foundation
name: Richard M Fleming, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Northern Iowa
name: Gordon M Harrington, PhD
role: PRINCIPAL_INVESTIGATOR
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