Cardiovascular Outcomes Of Diet Counseling
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ClinicalTrials.gov Identifier: NCT00324545 |
Recruitment Status :
Completed
First Posted : May 11, 2006
Last Update Posted : July 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease Obesity | Behavioral: Medium-intensity Minimally-directive Counseling | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
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 : | January 1, 2000 |
Actual Primary Completion Date : | December 31, 2002 |
Study Completion Date : | December 31, 2002 |
- coronary blood flow
- weight
- BMI
- LDLc
- Total Cholesterol
- HDLc
- Triglycerides
- Homocysteine
- Fibrinogen
- Lipoprotein (a)
- VLDLc
- TC/HDL
- TG/HDL (Insulin Resistance)
- CRP
- IL-6
- respiratory quotient

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Ages Eligible for Study: | 30 Years to 59 Years (Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324545
United States, Illinois | |
Keith Block | |
Chicago, Illinois, United States, 60201 | |
United States, Nebraska | |
Richard M. Fleming, MD | |
Omaha, Nebraska, United States, 68114 |
Principal Investigator: | Richard M Fleming, MD | Camelot Foundation | |
Principal Investigator: | Gordon M Harrington, PhD | University of Northern Iowa |
Responsible Party: | RM Fleming, MD, PI, The Camelot Foundation |
ClinicalTrials.gov Identifier: | NCT00324545 |
Other Study ID Numbers: |
2000-1-1 |
First Posted: | May 11, 2006 Key Record Dates |
Last Update Posted: | July 21, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Documents we are uploading onto Clinical Trials site. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | We are uploading information onto the Clinical Trials site. |
Access Criteria: | Direct email request may be made to primary email. |
Obesity Diets Heart Disease Randomized controlled trial Ischemia. |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |