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Cardiovascular Outcomes Of Diet Counseling

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00324545
Enrollment
120
Registered
2006-05-11
Start date
2000-01-01
Completion date
2002-12-31
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Obesity

Keywords

Obesity, Diets, Heart Disease, Randomized controlled trial, Ischemia.

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?

Interventions

BEHAVIORALMedium-intensity Minimally-directive Counseling

Sponsors

GM Harrington, PhD
CollaboratorUNKNOWN
The Camelot Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 59 Years
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.

Design outcomes

Primary

MeasureTime frame
coronary blood flow

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026