Cardiovascular Outcomes Of Diet Counseling
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Obesity |
Behavioral: Medium-intensity Minimally-directive Counseling |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
- 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
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | December 2002 |
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| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00324545 History of Changes |
| Other Study ID Numbers: |
2000-1-1 |
| Study First Received: | May 9, 2006 |
| Last Updated: | May 9, 2006 |
Keywords provided by The Camelot Foundation:
|
Obesity Diets Heart Disease Randomized controlled trial Ischemia. |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2017